Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biotechnology, competitiveness, consumer protection, foodstuff, foodstuffs legislation, innovation, medical research, pharmaceutical industry, public health, single market

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   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  COM(2025) 1022 final/2 2025/0406 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) {SWD(2025) 1055 final} (Text with EEA relevance)  
 
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Biotechnology  and  biomanufacturing  are  essential  to  the  EU’s  competitiveness,  strategic 
autonomy and economic security. They are a pillar of  the Union’s societal wellbeing in key 
areas such as health and food.  

This strategic importance is underscored by the sector’s rapid expansion. Over the last decade, 
the  EU  biotechnology  industry  has  grown  more  than  twice  as  fast  as  the  overall  EU 
economy  and  is  one  of  the  most  economically  productive  industries.  The  spillover  effect  is 
also  significant,  each  job  in  industrial  biotechnology  generates  3.4  additional  jobs  in  the 
broader economy.  In 2022, it accounted for EUR 38.1 billion of Union GDP and contributed 
to  913 160  jobs,  with  more  than  75%  of  those  jobs  (685 000)  coming  from  the  health 
biotechnology sector 1. 

However, the EU lags behind other global regions when it comes to translating its world-
class  science  and  innovation  into  commercially  viable  products,  and  even  more  so  in 
manufacturing such products at scale. Despite world-leading biotechnology science, reflected 
by  a  publication  record  comparable  to  that  of  the  US  and  China  (Figure  1),  the  EU  faces 
structural  barriers  in  clinical  development,  regulation  and  manufacturing.  As  a  result,  too 
often Union start-ups end up investing, growing, employing, creating value and placing their 
products  on  the  market  abroad  rather  than  in  the  EU.  This  is  especially  true  for  health 
biotechnology,  where  it  is  at  times  challenging  for  the  legislative  frameworks  to  keep  pace 
with the speed of scientific developments. 

Figure 1: Top tier life science publications of the EU compared to the USA and China 

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https://www.europabio.org/wp-content/uploads/2025/03/WifOR_EuropaBio2025.pdf 

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To remain a biotechnology powerhouse, the EU must make the most of its scale. Fragmented 
governance  and  suboptimal  coordination  across  Member  States  weaken  the  EU’s  ability  to 
deploy  industrial  facilities  at  scale,  resulting  in  underused  biomanufacturing  potential  - 
including  in  strategic  areas  such  as  biosimilars,  where  the  EU  has  strong  expertise  but 
insufficiently  exploited  capacity.  It  should  also  ensure  a  strong  alignment  between  the 
available labour supply and the specialised skills that the biotechnology and biomanufacturing 
sectors  will  require  in  the  future.  Current  skill  shortages  across  key  areas  including  R&D, 
regulatory affairs, AI, and data analytics further hinder Europe’s competitiveness. At the same 
time,  the  widening  gender  gap  and  the  untapped  potential  of  a  diverse  workforce  represent 
missed opportunities for innovation and resilience. 

Access to finance for scale-up funding in the EU remains limited compared to other regions. 
US  biopharma  start-ups  received  around  nine  times  more  late-stage  funding  than  EU 
biopharma  start-ups,  with  around  EUR 219  billion  of  venture  capital  focused  on  health 
biotechnology invested in the US compared to EUR 25 billion in the EU between 2015 and 
June 2025 (Figure 2). EU public equity markets for biotechnology also remain comparatively 
underdeveloped,  with  stock  exchanges  still  largely  fragmented  across  EU  Member  States 2. 
As a result, many EU scale-ups choose to list abroad: over the last six years, 66 out of 67 EU 
biotechnology  companies  that  went  public  chose  to  list  on  non-EU  stock  exchanges, 
illustrating the persistent structural disadvantages faced by EU-based innovators 3. 

Figure 2: Health Biotechnology investment in the EU compared to the US and China 

Aligned with the objectives of the AI Continent Action Plan and the Apply AI Strategy, the 
EU must also tap into the massive potential of AI for biotechnologies, addressing obstacles 
like  limited  testing  environments,  fragmented  data,  and  exploiting  the  full  potential  of  AI 
across  the  lifecycle  of  biotechnology  products,  in  particular  for  medicines.  Further, 

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Joint Research Centre (2024), Exploring the global landscape of biotechnology Innovation: preliminary 
insights from patent analysis,  https://publications.jrc.ec.europa.eu/repository/handle/JRC137266. 
From discovery to economic impact: Biotechnology Competitiveness for Europe, Vlaams Instituut voor 
Biotechnologie, 2024 

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Regulation (EU) 2024/1689 (AI Act)4, which entered into force in August 2024, lays down a 
uniform  legal  framework  in  particular  for  the  development,  the  placing  on  the  market,  the 
putting into service and the use of AI systems and models in the Union, in accordance with 
Union values, to promote the uptake of human centric and trustworthy AI. At the same time, 
biotechnology  introduces  new  biosecurity  risks  as  the  wider  accessibility  of  these 
technologies increases their potential for misuse, posing significant health threats. However, 
divergent  or  absent  national  rules  on  screening  biotechnology  products  with  significant 
potential  for  misuse,  such  as  the  synthetic  DNA  of  dangerous  pathogens,  raise  compliance 
costs, fail to offer a level playing field to competitors, and weaken prevention.  

Fragmentation and the complexity of the EU regulatory framework are factors that make 
the  EU  less  attractive  for  translating  cutting-edge  research  and  innovation  into  marketable 
products.  For  instance,  the  global  share  of  commercially  sponsored  clinical  trials  in  the 
European  Economic  Area  has  declined  from  22%  in  2013  to  12%  in  2023,  while  China’s 
share of commercial clinical trials rose from 5% to 18% in the same period, with the US share 
remaining  considerably  more  stable 5.  Importantly,  the  overall  reported  decline  in  small 
molecule  trials  suggests  a  strategic  shift  toward  the  development  of  biological  medicines  at 
the expense of small molecule programs. The drop in the number of small molecule trials was 
the most significant in Phase II trials from 62% in 2015 to 47% in 2024 and in Phase III trials 
from  65%  to  53%  during  the  same  period 6.  In  particular,  the  EU  is  losing  ground  to  other 
regions with increasingly agile regulatory and financial systems. Most of these regions issue 
decisions on validated clinical trial applications within 60 days, whereas in the EU it takes on 
average 113 days for multinational trials.  

Highlight: the need to simplify and streamline the Clinical Trials Regulation (CTR) 

Clinical  trials  in  the  EU  are  crucial  to  provide  patients  with  early  and  equal  access  to 
innovative  treatments,  uphold  scientific  excellence,  and  support  the  EU’s  long-term 
competitiveness  and  prosperity.  By  attracting  investment  in  research  and  development 
(R&D), creating jobs, and reducing healthcare costs, these trials deliver substantial economic 
and  societal  benefits.  They  also  significantly  benefit  patients  by  providing  earlier  access  to 
new therapies, including personalised therapies (e.g. for rare diseases and cancers), improving 
quality  of  life,  and  strengthening  the  evidence  base  for  clinical  guidelines,  marketing 
authorisation  and  health  technology  assessments.  The  share  of  clinical  trials  with  biological 
medicines seems to be increasing at the expense of low molecule trials. Biological medicines 
sales are key drivers of growth. In 2024, the European Union spent €228 Bn on medicines at 
list  prices,  including  €95  Bn  on  biological  medicines,  which  now  comprise  41%  of  total 
pharmaceutical spending. Increased clinical trials in the Union for biological medicines could 
potentially  contribute  to  more  manufacturing  in  the  Union,  higher  number  and  earlier 
regulatory submission of biological medicines for marketing authorisation applications and a 
higher  percentage  of  EU  clinical  data  in  marketing  authorisation  applications.  A  conducive 
environment  for  clinical  trials  is  essential  to  speed-up  market  access  for  novel  medicines, 

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Regulation  (EU)  2024/1689  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  laying 
down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 
167/2013,  (EU)  No  168/2013,  (EU)  2018/858,  (EU)  2018/1139  and  (EU)  2019/2144  and  Directives 
2014/90/EU,  (EU)  2016/797  and  (EU)  2020/1828  (Artificial  Intelligence  Act)  (Text  with  EEA 
relevance), OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj 
European  Federation  of  Pharmaceutical  Industries  and  Association,  Assessing  the  clinical  trial 
ecosystem in Europe (2024) assessing-the-clinical-trial-ecosystem-in-europe.pdf 
Global Trends in R&D 2025 - IQVIA 

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especially  against  global  competition.  There  are  still  significant  regulatory  fragmentations 
across  Member  States  that  limit  the  system’s  efficiency.  Against  this  background,  further 
regulatory  streamlining  and  simplification  of  the  authorisation  and  conduct  of  clinical  trials 
are  imperative.  This  is  a  key  point  of  the  Draghi  report  on  the  future  of  European 
Competitiveness 7,  which  highlights  the  need  to  address  these  inefficiencies,  stressing  the 
importance of reducing regulatory delays and administrative burdens. It calls for harmonised 
templates, stronger coordination between national ethics committees, and a greater emphasis 
on using artificial intelligence (AI) and digital tools to streamline the process. At a time when 
global competitors – particularly the US, China, and Japan – are rapidly improving their R&D 
incentives and regulatory agility, Europe risks losing its competitive edge in clinical research. 
The EU’s position in the global clinical trial landscape has already weakened, and immediate 
action is needed to close this gap. 

This  is  why  a  European Biotech Act was announced by the  President of the European 
Commission in the 2024 - 2029 Political Guidelines of the Commission 8, with the aim of 
creating an enabling environment to make it easier to bring biotechnology products from the 
laboratory  to  the  factory  and  then  onto  the  market,  while  maintaining  the  highest  safety 
standards  for  the  protection  of  the  population  and  the  environment.  As  previously 
acknowledged in the Communication on Biotechnology and Biomanufacturing (March 2024) 
and  the  reports  by  Enrico  Letta 9  (April  2024)  and  Mario  Draghi 10  (September  2024),  it  is 
necessary to address the challenges faced by EU companies, users and consumers to boost the 
EU’s  technological  advancement,  competitiveness  and  economic  growth.  In  its  resolution 
‘Future  of  the  EU  biotechnology  and  biomanufacturing  sector’ 11,  the  European  Parliament 
recommended ‘facilitating a fast and efficient uptake of biotechnology and biomanufacturing 
through  clear  regulatory  frameworks’.  The  European  Parliament  is  now  preparing  an  own-
initiative  report  on  ‘Public  health  aspects  of  biotechnology  and  life  sciences’ 12.  More 
recently, EU Member States urged the Commission to unlock the potential of biotechnologies, 
by  reducing  fragmentation  and  simplifying  the  EU  regulatory  framework  across  policy 
areas13. 

the 

importance  of  health  biotechnology  amongst 

the  other  applications  of 
Given 
biotechnology  as,  it  is  appropriate  that  the  European  Biotech  Act  focusses  on,  and  sets  out 
specific measures for, the health dimension of biotechnology. To ensure the effectiveness of 
this  proposal,  its  scope  of  application  extends  to  health  biotechnology  in  a  comprehensive 
manner  and  cover  health  within  the  wide  meaning  of  Article  168  of  the  Treaty  of  the 
Functioning of the European Union (TFEU) on the protection of public health. In this regard, 
Article 168(1) TFEU emphasises that a high level of human health protection is to be ensured 

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Draghi,  Mario.  The  future  of  European  competitiveness:  A  competitiveness  strategy  for  Europe, 
European Commission, 9 September 2024. 
European  Commission  (2024),  Political  Guidelines  for  the  Next  European  Commission  2024-2029, 
e6cd4328-673c-4e7a-8683-f63ffb2cf648_en 
Enrico Letta (2024), Much more than a Market. Enrico Letta - Much more than a market (April 2024) 
Draghi,  Mario.  The  future  of  European  competitiveness:  A  competitiveness  strategy  for  Europe, 
European Commission, 9 September 2024. 
European Parliament (2025). Future of the EU biotechnology and biomanufacturing sector: leveraging 
research,  boosting  innovation  and  enhancing  competitiveness.  Texts  adopted  -  Future  of  the  EU 
biotechnology  and  biomanufacturing  sector:  leveraging  research,  boosting  innovation  and  enhancing 
competitiveness - Thursday, 10 July 2025 
European Parliament: 2025/2087(INI) 
Council  of  the  European  Union,  A  call  for  action  on  life  sciences  for  the  Union's  competitiveness  - 
Council conclusions (approved on 30 September 2025) (13323/25).  

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when  defining  and  implementing  all  Union  policies  and  activities.  Article  168(4)  TFEU 
clarifies  that  this  objective  is,  amongst  others,  to  be  pursued  through  measures  setting  high 
standards  of  quality  and  safety  for  medicinal  products  and  devices  for  medical  use  and  of 
organs  and  substances  of  human  origin,  blood  and  blood  derivatives,  measures  in  the 
veterinary  and  phytosanitary  fields  which  have  as  their  direct  objective  the  protection  of 
public health. Accordingly, and in line with the One Health approach, this Regulation should 
apply  to  health biotechnology,  understood as the application of biotechnology  in  the human 
medical,  veterinary,  pharmaceutical  and  phytosanitary  areas  for  the  development  of 
biotechnology  products  and  services.  The  Regulation  should  apply  to  their  entire  lifecycle, 
including the related research, access to funding, development, innovation, testing, validation, 
manufacturing, placing on the market and use activities. 

The  proposal  for  a  European  Biotech  Act  acknowledges  the  EU’s  potential  to  be  a  global 
leader.  The  region  combines  a  highly  skilled  workforce,  world-class  scientific  institutes, 
innovative startups and scaleups, advanced infrastructure and large private capital pools that 
could  be  used  to  support  the  domestic  scale-up  of  promising  companies.  The  proposal 
therefore  seeks  to  address  the  barriers  hindering  the  development  of  the  EU’s  health 
biotechnology sector, starting from early-stage research through to later-stage deployment and 
scale-up.  It  introduces  facilitation  measures  in  the  health  biotechnology  areas,  including  a 
framework for the recognition of, and support for, health biotechnology strategic projects and 
high  impact  health  biotechnology  strategic  projects,  aimed  at  reducing  time-to-market,  with 
particular  attention  paid  to  the  needs  of  small  and  medium-sized  enterprises  (SMEs),  and 
includes future-proofing  provisions to anticipate the needs of health biotechnologies.  Acting 
decisively  now  will  allow  the  EU  to  fully  harness  its  fast-moving  biotechnology  sector, 
reinforce strategic autonomy and economic security, and lay the foundations for a competitive 
and forward-looking EU biotechnology sector.   

With  a  view  to  ensure  the  effectiveness  of  the  substantive  provisions  put  forward  in  this 
proposal, amendments to Union legislation in the areas of health and food and feed safety are 
also established for regulatory simplification, that have an impact on innovation and the time 
to  market  for  biotechnology  products  and  services,  including  where  such  legislation  also 
applies  to  products  other  than  biotechnology  products.  In  this  regard,  without  an  efficient, 
accelerated  and  streamlined  legislative  framework  for  clinical  trials  in  the  Union,  the  other 
measures in this Regulation, and in particular the framework for the recognition and support 
of  health  biotechnology  strategic  projects  and  high  impact  biotechnology  strategic  projects 
would  be  deprived  of  their  effectiveness,  as  all  health  biotechnology  medicinal  products 
require state of the art clinical research and a globally competitive regulatory framework for 
clinical trials authorisation. Similarly, a timelier risk assessment process for products subject 
to pre-market authorisation in accordance with Union food and feed legislation, including for 
biotechnology  innovations  where  pre-submission  advice  of  the  European  Food  Safety 
Authority for aspects such as study design is paramount, as well as accelerated procedures are 
needed  for  the  effectiveness  of  the  substantive  facilitation  measures  put  forward  in  this 
proposal.  

In  a  second  stage,  following  this  health-focused  initiative,  the  Commission  will  address  in 
2026 the wider biotech ecosystem beyond health to ensure a competitive internal market for 
all areas of biotechnology. 

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Figure 3: Biotechnology and biomanufacturing sector in Europe, problem tree 

• 

Consistency with existing provisions in the policy area 

The European Biotech Act will seek to streamline the relevant EU legislative frameworks to 
create an enabling environment for innovation and development in order to accelerate time to 
market. With its primary focus on health, the present proposal will amend the Regulation on 
clinical  trials  (CTR)14,  the  Regulation  on  advanced  therapy  medicinal  products 
(ATMPs)15, the Regulation on standards of quality and  safety for substances of human 
origin  intended  for  human  application  (SoHO)16  and  the  Regulation  on  veterinary 
medicinal products (VMPs) 17. In the field of food safety, the proposed measures are built on 
the  General  Food  Law18.  The  proposal  will  also  amend  the  legislation  on  the  deliberate 
release of genetically modified organisms (GMO)19. 

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relevance),  OJ  L 

Regulation  (EU)  No  536/2014  of  the  European  Parliament  and  of  the  Council  of  16  April  2014  on 
clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA 
relevance, OJ L 158, 27.5.2014, pp. 1–76. ELI: http://data.europa.eu/eli/reg/2014/536/oj. 
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 
on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 
121–137. 
(Text  with  EEA 
726/2004 
ELI: http://data.europa.eu/eli/reg/2007/1394/oj. 
Regulation  (EU)  2024/1938  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  on 
standards  of  quality  and  safety  for  substances  of  human  origin  intended  for  human  application  and 
repealing  Directives  2002/98/EC  and  2004/23/EC  (Text  with  EEA  relevance),  OJ  L,  2024/1938, 
17.7.2024. ELI: http://data.europa.eu/eli/reg/2024/1938/oj. 
Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  of  11  December  2018  on 
veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance), OJ L 4, 
7.1.2019, pp. 43–167. ELI: http://data.europa.eu/eli/reg/2019/6/oj. 
Regulation  (EC)  No  178/2002,  of  the  European  Parliament  and  of  the  Council  of  28  January  2002 
laying  down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food 

10.12.2007, 

324, 

pp. 

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The  proposal  also  considers  other  existing  legislation  that  is  being  revised  to  ensure  the 
coherence  of  the  overall  EU  regulatory  system,  in  particular  the  Regulation  on  medical 
devices  (MDR)  and  the  Regulation  on  in  vitro  diagnostic  medical  devices  (IVDR) 20,  as 
well as the proposed simplification measures in food and feed safety legislation (food and 
feed simplification package). 

The Biotech Act will also exploit synergies with other EU legislation. It will complement the 
Critical  Medicines  Act  (CMA) 21  to  strengthen  EU-based  biotechnology  research  and 
manufacturing.  The Act  is  also  in  line with  the  pharmaceutical  strategy for  Europe22  and 
complements  the  ongoing  revision  of  the  EU  pharmaceutical  legislation23  to  create  the 
appropriate conditions for biotechnology  from the innovation stage. Moreover, the proposed 
measures are complementary to the proposed regulation on plants obtained by certain new 
genomic techniques and their use in food and feed.  

Consistency with other Union policies 

• 
As one of the flagship initiatives of the  Competitiveness  Compass24, the proposed Biotech 
Act  aligns  with  the  EU’s  broader  innovation  and  competitiveness  agenda,  translating  the 
priorities of the Compass into concrete actions within the strategic sector of biotechnology. 

In  particular,  the  Biotech  Act  is  part  of  the  Commission’s  life  sciences  strategy25.  It  was 
presented  as  a  central  instrument  to  strengthen  the  Union’s  biotechnology  ecosystem, 
streamline  regulatory  procedural  pathways  and  boost  Europe’s  competitiveness  in  life 
sciences, recognising biotechnology as a strategically critical and cross-sectoral technology. 

Furthermore, the proposed Act is complementary to the other policy initiatives announced in 
the  Compass.  First,  it  aims  to  improve  access  to  later-stage  capital  for  biotechnology  firms, 

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Safety Authority and laying down procedures in matters of food safety,  OJ L 31, 1.2.2002, pp. 1–24. 
ELI: http://data.europa.eu/eli/reg/2002/178/oj. 
Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive  90/220/EEC 
-  Commission  Declaration,  OJ  L  106,  17.4.2001,  pp.  1–39. 
ELI: http://data.europa.eu/eli/dir/2001/18/oj. 
Regulations (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009  and  repealing  Council  Directives  90/385/EEC  and  93/42/EEC  (Text  with  EEA  relevance), 
OJ L 117, 5.5.2017, pp. 1–175. ELI: http://data.europa.eu/eli/reg/2017/745/oj and (EU) 2017/746 of the 
European  Parliament  and  of  the  Council  of  5  April  2017  on  in  vitro  diagnostic  medical  devices  and 
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance), OJ L 
117, 5.5.2017, pp. 176–332. ELI: http://data.europa.eu/eli/reg/2017/746/oj. 
Critical medicines Act - Public Health - European Commission  
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  Pharmaceutical  Strategy  for 
Europe, COM/2020/761 final. 
European Commission website, Reform of the EU pharmaceutical legislation 
European  Commission,  European  Competitiveness  Outlook 
Competitiveness compass - European Commission 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, Choose Europe for life sciences A 
strategy  to  position  the  EU  as  the  world’s  most  attractive  place  for  life  sciences  by  2030, 
COM/2025/525 final. 

(Competitiveness  Compass): 

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aligning with the start-up and scale-up strategy 26 and complementing the Scaleup Europe 
Fund  established  under  that  strategy,  as  well  as  the  Savings  and  Investments  Union 27, 
which seeks to mobilise larger pools of private capital, support investment within the EU, and 
reduce financing costs for Union businesses.  

Second,  the  provisions  on  biosecurity  also  reflect  the  Compass’s  emphasis  on  talent  as  a 
cornerstone  of  innovation  and  on  the  interdependence  between  economic  strength  and 
security. In this context, the Act is consistent with the objectives put forward in the Union of 
Skills 28  and  contributes 
to  EU  security  by  reinforcing  safeguards  for  dual-use 
biotechnologies. It also complements the EU Regulation (EU) 2022/2371 on serious cross-
border threats to health 29, helping  to  ensure a coordinated Union-level  response to  health 
risks  that  may  arise  from  the  misuse  of  emerging  biotechnologies  and  to  the  strategic 
technologies for Europe platform (STEP) 30 that also target biotechnologies. 

Third, the emphasis on the use of AI in the proposed Act also aligns with the Competitiveness 
Compass, and echoes the recent  Apply  AI  strategy 31, the AI continent  action  plan 32, the 
European  AI  Act 33  and  the  Data  Union  strategy 34,  which  stress  the  need  to  strengthen 
Europe’s 
technological  competitiveness  and  secure,  data-driven 
ecosystems while supporting the biotechnology landscape.  

innovation  capacity, 

Overall, the Biotech Act is also consistent with the vision for agriculture and food 35., as it 
amends the General Food Law to broaden the scope of pre-submission advice provided by the 
European Food Safety Authority (EFSA) to study design, and reforms the EFSA Panel system 
to speed up risk assessment procedures. 

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32 
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35 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  The  EU  Startup  and  Scaleup 
Strategy Choose Europe to start and scale, COM/2025/270 final. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, Savings and Investments Union A 
Strategy to Foster Citizens’ Wealth and Economic Competitiveness in the EU, COM/2025/124 final. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, The Union of Skills, COM/2025/90 
final. 
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on 
serious  cross-border  threats  to  health  and  repealing  Decision  No  1082/2013/EU  (Text  with  EEA 
relevance), OJ L 314, 6.12.2022, pp. 26–63. ELI: http://data.europa.eu/eli/reg/2022/2371/oj. 
Strategic Technologies for Europe Platform 
Communication from the Commission to the European Parliament and the Council, Apply AI Strategy, 
COM/2025/723 final. 
https://ec.europa.eu/newsroom/dae/redirection/document/114523  
Regulation  (EU)  2024/1689  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  laying 
down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 
167/2013,  (EU)  No  168/2013,  (EU)  2018/858,  (EU)  2018/1139  and  (EU)  2019/2144  and  Directives 
2014/90/EU,  (EU)  2016/797  and  (EU)  2020/1828  (Artificial  Intelligence  Act),  OJ  L,  2024/1689, 
12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj. 
Communication  from  the  Commission  to  the  European  Parliament  and  the  Council,  Data  Union 
Strategy Unlocking Data for AI, COM(2025) 835 final. 
Communication  from  the  European  Parliament,  the  Council,  the  European  Economic  and  Social 
Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an 
attractive farming and agri-food sector for future generations, COM/2025/75 final 

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Lastly, the proposed Act was informed by the preparation of upcoming and recent initiatives, 
such  as  the  future  European  Innovation  Act 36  and  the  recently  adopted  bioeconomy 
strategy 37, in order to ensure synergies.  

Furthermore, climate change has shown the need to also prioritise the resilience of the Union, 
including,  for instance to focus on sustainable food systems,  stronger health prevention and 
innovative health solutions. In this context, biotechnology has been identified in the Farm to 
Fork Strategy 38, which is a key component of the European Green Deal 39, as a technique 
that is safe for consumers and the environment. The proposed Act is also consistent with the 
European  Commission’s  objectives  to  achieve  climate  neutrality  set  out  in  the  EU  Climate 
Law 40 and the Union’s Strategy on Adaptation to Climate Change 41.  

In  this  context,  the  proposed  European  Biotech  Act,  including  through  its  measures 
supporting  innovation,  will  accelerate  the  placing  on  the  market  of  biotechnology  products 
that  are  adaptable  to  climate  change,  that  contribute  to  health  and  food  security  through 
sustainable  biomanufacturing  and  to  the  protection  of  biodiversity.  Such  biotechnology 
products  have  also  the  potential  to  replace  products  potentially  more  harmful  for  the 
environment  while  providing  great  benefits  for  consumers  and  users.  Biotechnology  and 
biomanufacturing will also need to comply with Union legislation in these areas, such as, the 
Regulation  concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals (REACH)42 or applying without prejudice to the provisions of Regulation (EU) 
2024/1735 regarding sustainable biogas and biomethane technologies and biotechnology 
climate and energy solutions43. 

This also shows that the proposed Act is in line with the ‘do no significant harm’ principle. 
The  positive  environmental  impact  of  biotechnology  and  biomanufacturing  was  also 
recognized by stakeholders in their responses to the Public Consultation. 

36 

37 

38 

39 

40 

41 

42 

43 

(‘European  Climate 

European  Commission  ‘Have  your  say’  website:  https://ec.europa.eu/info/law/better-regulation/have-
your-say/initiatives/14593-European-Innovation-Act_en  
European  Commission  ‘Have  your  say’  website:  https://ec.europa.eu/info/law/better-regulation/have-
your-say/initiatives/14555-Towards-a-circular-regenerative-and-competitive-bioeconomy_en  
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, 
healthy and environmentally-friendly food system, COM/2020/381 final 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  The  European  Green  Deal, 
COM/2019/640 final. 
Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing 
the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 
1–17.  ELI: 
2018/1999 
http://data.europa.eu/eli/reg/2021/1119/oj.  
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, Forging a climate-resilient Europe 
- the new EU Strategy on Adaptation to Climate Change, COM/2021/82 final 
Consolidated text: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 
December  2006  concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing 
Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (Text with EEA relevance). ELI: http://data.europa.eu/eli/reg/2006/1907/2025-09-01 
Consolidated  text:  Regulation  (EU)  2024/1735  of  the  European  Parliament  and  of  the  Council  of  13 
June  2024  on  establishing  a  framework  of  measures  for  strengthening  Europe’s  net-zero  technology 
manufacturing ecosystem and amending Regulation (EU) 2018/1724 (Text with EEA relevance). ELI: 
http://data.europa.eu/eli/reg/2024/1735/2025-08-17 

Law’),  OJ  L 

9.7.2021, 

243, 

pp. 

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Finally,  the  proposed  Biotech  Act  will  support  digital  transformation  in  line  with  the 
‘digital by default’ principle. One of its specific objectives is to “facilitate the application of 
AI  into  the  Union’s  biotechnology  and  health  technology  manufacturing  ecosystems  and 
frameworks, in line with Regulation (EU) 2024/1689”. The Act is expected, among others, to 
support the use of data, digital platforms and analytical methodologies (e.g. reducing the need 
in  biomanufacturing. 
the  development  of  biotechnology  and 
for  clinical  data),  in 
Digitalisation  will  also  be  reinforced  in  networking  cooperation  of  biotechnology  clusters 
(e.g.  through  the  promotion  of  the  development  of  infrastructure  and  digital  platforms,  and 
AI-enabled technologies). Overall, accelerated digitalisation, in particular through greater data 
use and AI integration, aims at contributing to the Union’s technological sovereignty.  

Moreover,  the  proposed  European  Biotech  Act  will  ensure  coherence  with  relevant  digital 
policies, such as the Artificial Intelligence Act44, on development and testing of AI enabled 
biotechnology solutions, as well as the EU Cybersecurity framework45, on access principles 
and security safeguards. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  general  objective  of  this  Regulation  is  threefold:  (i)  to  improve  the  functioning  of  the 
internal  market  by establishing a framework to  strengthen the competitiveness  of the  health 
biotechnology  sector,  from  research  to  production,  (ii)  to  create  the  conditions  for  the 
development  and  timely  placing  on  the  EU  market,  of  biotechnology  innovations,  products 
and  services,  (iii)  while  safeguarding  high  standards  for  the  protection  of  human  health, 
animal health, patients and consumers, the environment, ethics, quality, food and feed safety, 
and biosecurity. 

This general objective translates into the establishment of measures to: 

(i) 

(ii) 

strengthen  the  biotechnology  sector  and  reinforce  the  EU’s  research,  development 
and production capabilities, by establishing a framework for the recognition of, and 
support  measures  for,  strategic  health  biotechnology  projects  and  high  impact 
strategic health biotechnology projects (pillar 1); 

support  funding  of,  investments  in,  and  access  to  capital  for,  biotechnology 
companies  and  projects,  including  through  the  setting  up  of  an  EU  health 
biotechnology  investment  pilot  to  fill  the  gap  in  spending  on  biotechnology 
innovation (pillar 2); 

(iii) 

improve  the  EU  manufacturing  capacity  of,  and  expertise  in  biosimilars,  including 
through international cooperation (pillar 3); 

44 

45 

Regulation  (EU)  2024/1689  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  laying 
down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 
167/2013,  (EU)  No  168/2013,  (EU)  2018/858,  (EU)  2018/1139  and  (EU)  2019/2144  and  Directives 
2014/90/EU,  (EU)  2016/797  and  (EU)  2020/1828  (Artificial  Intelligence  Act)  (Text  with  EEA 
relevance), OJ L, 2024/1689, 12.7.2024. ELI: http://data.europa.eu/eli/reg/2024/1689/oj  
Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA 
(the  European  Union  Agency  for  Cybersecurity)  and  on  information  and  communications  technology 
cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (Text with 
EEA relevance), OJ L 151, 7.6.2019, pp. 15–69. ELI: http://data.europa.eu/eli/reg/2019/881/oj 

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(iv) 

(v) 

(vi) 

(vii) 

facilitate the application of AI into the Union’s biotechnology and health technology 
manufacturing  ecosystems  and  frameworks,  in  line  with  the  Regulation  (EU) 
2024/1689 (pillar 4); 

ensure  a  legislative  framework  that  encourages  innovation  and  takes  account  of 
technological  and  scientific  developments  and  progress,  by  establishing  provisions 
for health biotechnology products (pillar 5);  

prevent  the misuse of biotechnologies and strengthen biodefence capabilities (pillar 
6). 

enable the effectiveness of the measures under the pillars 1 to 6 through a legislative 
framework conducive to the use of biotechnology innovations,  by amending  Union 
legislation  in  particular  on  clinical  trials,  veterinary  medicinal  products,  food  and 
feed safety and related legislation (pillar 7).  

The appropriate legal basis is therefore as follows: 

– 

– 

– 

Article 114 of the Treaty on the Functioning of the European Union (‘TFEU’) which 
allows  the  EU  to  take  measures  that  increase  harmonisation  and  remove 
fragmentation to create a level playing field within, and fully exploit the scale of, the 
EU single market, so that the health biotechnology and biomanufacturing sectors can 
thrive.  In  accordance  with  Article  114(3)  TFEU,  the  proposal  seeks  to  achieve  the 
objective of a high level of health and safety protection. 

Article 168(4) TFEU, which mandates the Union to contribute to the achievement of 
a  high  level  of  human  health  protection  through  the  adoption  -  in  order  to  meet 
common safety concerns - of (i) measures setting high standards of quality and safety 
of organs and substances of human origin, blood and blood derivatives; (ii) measures 
in  the  veterinary  and  phytosanitary  fields  which  have  as  their  direct  objective  the 
protection of public  health; and (iii) measures setting  high standards of  quality and 
safety for medicinal products and devices for medical use. 

Article  173(3)  TFEU,  which  allows  the  Union  to  decide  on  specific  measures  in 
support of action taken in the Member States to ensure the conditions necessary for 
the competitiveness of the Union’s industry, excluding any harmonisation of the laws 
and  regulations  of  the  Member  States.  This  article  provides  a  legal  basis  for  the 
provisions  in  this  Regulation  regarding  the  EU  health  biotechnology  investment 
pilot,  establishing  the  basis  for  future  Union  financial  support  together  with 
implementing  partners,  to  support  the  financing  of,  and  investments  in,  companies 
and projects falling within the scope of the European Biotech Act. 

• 

Subsidiarity (for non-exclusive competence) 

The  objectives  of  the  proposal  cannot  be  achieved  by  Member  States  acting  alone,  as  the 
issues tackled are of a cross-border nature and are not limited to single Member States or to 
several  Member  States.  The  proposed  actions  focus  on  areas  where  there  is  a  demonstrable 
value added in acting at EU level due to the scale, speed, and scope of the efforts needed.  

Furthermore, the market drivers identified are shared across the Member States, affecting the 
functioning of the single market and the global competitiveness of EU companies. Access to 
finance  is  scattered  across  the  EU  and  EU  companies  lack  the  capacity  to  access  private 
finance at a competitive scale, including at later stages of development. Similarly, European 
biotechnology  clusters  are  scattered  across  the  EU,  without  sufficient  continental  scale  to 
compete  globally.  The  development  and  deployment  of  AI  solutions  for  biotechnology 

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remains limited, also due to the low level of storage, access and sharing of data relevant for 
biotechnology in the EU, including across borders. There is also a clear need across the EU to 
attract, reskill and upskill the workforce. 

Moreover,  while  several  Member  States  have  taken  action  to  boost  innovation  in 
biotechnology,  the  above-mentioned  bottlenecks  persist;  improvements  are  expected  to  take 
considerably  more time  and without achieving the levels  needed to  compete at  global level. 
For example, access to finance would remain scattered at EU level. The growth of clusters in 
the EU would also remain limited, without sufficient benefits from cross-border connections. 

Lastly, important regulatory barriers faced by European biotechnology companies stem from 
EU legislation. Therefore, with a view to enable the effectiveness of the substantive measures 
put forward in this proposal, it is proposed to simplify EU legislation in the area of health and 
of  food  and  feed  safety  to  make  it  easier  to  innovate  and  place  biotechnology  products  and 
services on the Union market and to enhance legal clarity.  

• 

Proportionality 

The  selected  measures  under  the  industrial  policy  and  substantive  part  of  the  proposal  are 
targeted at the specific areas of interventions listed below.  

– 

The provisions  on strategic health  biotechnology  projects  and  high-impact strategic 
health  biotechnology  projects  are  proportionate  to  the  aims  pursued,  including  by 
recognising  the  first  category  of  projects  at  Member  State  level,  and  the  second 
category at EU level on the basis of an assessment at Member State level. Moreover, 
the  recognition  of  such  projects  is  based  on  clear  criteria  tailored  to  ensure  that 
projects that contribute substantially to the Union’s competitiveness, resilience, and 
security fall within the enhanced support regime. Moreover, the recognition of such 
projects  does  not  restrict  Member  States’  ability  to  support  additional  projects 
through  other  instruments.  Member  States  benefit  from  flexibility  as  regards  the 
authorities that they intend to designate to recognise strategic  health biotechnology 
projects  and  assess  applications  for  high-impact  strategic  health  biotechnology 
projects. This flexibility also applies to the single points of contact and the provision 
of  administrative,  technical,  and  financial  support,  in  line  with  Union  law  and  the 
national systems. Accelerated permitting timelines apply only to recognised projects 
and  are  designed  to  streamline  procedures  without  lowering  any  environmental, 
health or safety standards. 

Similarly, measures aimed at supporting networking among health biotechnology clusters are 
limited  to  what  is  necessary  to  foster  synergies  in  the  internal  market,  while  the  EU  Health 
Biotechnology Support Network is aiming to build on and complement existing national and 
EU structures, avoiding any duplication. 

– 

– 

On access to funding, the interventions focus on measures mobilising public funding 
and private capital; public funding needs to be in line with State aid rules. 

The  proposed  interaction  modalities  with  Member  States  in  the  context  of  a 
European Health Biotechnology Steering Group allows for priorities to be adjusted, 
including  by  ensuring  that  the  support  measures  for  strategic  health  biotechnology 
project  and  high-impact  strategic  health  biotechnology  projects  remain  closely 
aligned with the Regulation’s general objective. 

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The  proposed  amending  provision  aimed  at  reducing  the  time-to-market  of  biotechnology 
products  and  services  focus  on  certain  sectoral  Union  legislation  where  room  for 
simplification  of 
identified. 
Simplification relates to changes that are necessary with a view to secure the effectiveness of 
the  substantive  provisions  put  forward  in  this  proposal  and  will  improve  the  legal  clarity, 
certainty, and overall efficiency of the concerned EU legislative frameworks.  

regulatory  and  administrative  complexities  has  been 

• 

Choice of the instrument 

The proposal takes the form of a regulation of the European Parliament and of the Council. 

A  regulation  is  the  most  suitable  legal  instrument  for  Pillars  1  to  4,  given  the  need  for  a 
uniform  application  of  the  new  rules,  in  particular  the  conditions  and  procedure  for 
recognising  heath  biotechnology  strategic  projects  and  high  impact  health  biotechnology 
strategic projects, and for their administrative, technical and financial support, and also more 
broadly  for  companies  and  non-profit  organisations  active  in  the  relevant  biotechnology 
sectors across the internal market. This is also the case for Pillar 5, regarding the provisions 
on  biotechnology  health  products,  given  that  they  aim  to  ensure  a  dialogue  and  more 
flexibility  across  the  Union  legislative  frameworks  in  the  area  of  health.  The  choice  of  a 
regulation as a legal instrument is also appropriate for Pillar 6 because only a regulation, with 
its directly applicable legal provisions, can provide the necessary degree of uniformity needed 
to boost EU biodefence and biosecurity and prevent biotechnology misuse. 

In all cases, the choice of the instrument is justified considering that the  Pillar 7 establishes 
provisions  amending  several  existing  Union  regulations  in  the  area  of  health  and  food  and 
feed safety. 

Lastly, a regulation is appropriate for the provisions regarding on evaluating this Regulation 
which do not need to be transposed through national measures and are directly applicable. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

The proposed measures amend several pieces of EU legislation in a targeted manner, without 
modifying their objectives, the overall regulatory framework put in place or their functioning. 
When relevant, these measures were informed by several studies or ongoing evaluations, such 
as the ongoing evaluation of the EFSA. Regarding the Clinical Trials Regulation, an ongoing 
study will contribute to the Commission’s report, which will be presented five years after the 
application date of the legislation (1 January 2022).  

The  extensive  consultation  process  and  a  comprehensive  supporting  study  identifying  over 
200  regulatory  challenges  stemming  from  EU  legislation  have  gathered  evidence  on  the 
challenges and problems, the relevant provisions of the legislation, and issues for which there 
is no legislation.  

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• 

Stakeholder consultations  

Extensive  stakeholder  consultations  were  carried  out  to  prepare  for  the  proposal.  A  call  for 
evidence 46, opened for feedback from 14 May to 11 June 2025, gathered 222 valid individual 
contributions47  from  a  wide  range  of  stakeholders:  business  associations 48  (63),  companies 
(50), non-governmental  organisations (NGOs) (44), academic  and research institutions (20), 
public authorities in the EU (14), EU citizens (14) and other categories (17) 49.  

Figure 4: submissions to the call for evidence 

The  respondents  were  largely  based  in  the  EU  (197  responses  from  15  Member  States). 
Among these, most of the contributions came from Belgium (74), followed by Germany, (29), 
France  (20),  the  Netherlands  (16),  Denmark  (12)  and  Spain  (11).  25  contributions  were 
received  from  7  non-EU  countries  (the  United  States,  Switzerland,  the  United  Kingdom, 
Norway, Canada, Australia and Argentina).  

With  regard  to  current  biotechnology  related  regulation,  various  stakeholder  groups  such  as 
academic/research  institutions,  NGOs,  representatives  of  companies  (including  SMEs),  and 
public  authorities  underlined  slow  and  complex  regulatory  frameworks  that  lead  to  long 
authorisation/approval  processes,  thereby  hindering  innovation  and  delaying  market  access. 
Representatives  from  businesses  (both  associations  and  large  companies)  referred  to  the 
unpredictability 
from 
academic/research  institutions  and  business  associations  also  expressed  concerns  regarding 
outdated  regulatory  frameworks,  while  business  associations  mentioned  in  particular  the 
limited  flexibility  of  the  EU  regulatory  frameworks.  In  addition,  NGOs/others,  large 
companies and SMEs, business associations and trade unions agreed that divergent national 
rules  and  interpretation/implementation  of  EU  rules  create  fragmented  market  entry 

procedures.  Representatives 

authorisation 

some 

of 

46 

47 

48 

49 

European  Commission  ‘Have  your  say’  website:  https://ec.europa.eu/info/law/better-regulation/have-
your-say/initiatives/14627-Biotech-Act_en  
Three submissions were received from a single respondent and have been counted as one response. Two 
submissions were received from another respondent and have been counted as one response. 
Three  respondents  that  selected  trade  unions  are  analysed  together  with  business  associations  as 
representing the industry. 
In the analysis, they are grouped together with feedback from NGOs. 

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conditions. Feedback from small companies indicated high regulatory costs as a result of the 
regulatory fragmentation, while public authorities also acknowledged high compliance costs. 
Lastly,  some  feedback  pointed  to  inconsistencies  between  EU  legislative  frameworks,  in 
particular  the  CTR,  ATMPs  Regulation,  MDR/IVDR,  REACH  Regulation  and  the  General 
Data Protection Regulation (GDPR). 

Most stakeholders also indicated a shortage of risk-tolerant capital. Stakeholders highlight 
fragmented funding schemes, limited early-stage financing, and low EU venture capital 
share  compared  to  the  US  and  China.  For  instance,  representatives  from  academic/research 
institutes  indicated  that  the  EU’s  venture  capital  accounted  for  only  about  5%  of  global 
venture  capital.  Representatives  of  large  companies  particularly  underlined  public  R&D 
under-investment,  indicating  poor  alignment  across  policies  and  programmes.  Some 
contributions  from  NGOs/others  also  indicated  the  risk  of  dependence  on  foreign  capital, 
particularly in health and defense-related biotechnologies. 

Stakeholders stressed the fundamental role of education and skills for the biotechnology and 
biomanufacturing workforce. Stakeholders expressed concerns about talent drain and global 
competition. This is exacerbated by existing regulatory and mobility barriers that hamper 
cross-border  and  cross-sector  mobility,  as  indicated  in  feedback  from  academic/research 
institutions. In addition, stakeholders underlined the limited entrepreneurial pathways from 
academia to  company  building.  Moreover, many stakeholders experienced shortages in  the 
specialised  and 
the  biotechnology  and 
biomanufacturing  workforce.  Other  limitations  mentioned  were  an  insufficient  number  of 
STEM graduates, the lack of funding or low investment in life-long learning (e.g. digital, AI 
competencies), and unequal access to upskilling programmes. 

interdisciplinary  competences  needed  for 

(including  academic/research 

Stakeholders  across  all  groups 
institutions,  business 
associations/trade  unions,  large  companies,  citizens,  as  well  as  NGOs/others  and  public 
authorities)  stressed  the  limited  manufacturing  capabilities  in  the  Union.  Some  of  the 
underlying  factors  mentioned  were,  among  others,  the  high  costs,  infrastructure  and 
investment  gaps,  limited  digitalisation,  supply  chain  vulnerabilities,  and  the  fragmented 
regulatory  frameworks.  SMEs  underscored  this  statement,  also  pointing  to  the  challenges 
related to lack of recognition for quality control technologies. 

Furthermore,  incubation  and  acceleration  limitations  in  the  EU  were  mentioned.  Many 
stakeholder  groups,  such  as  academic/research  institutions,  large  companies,  NGOs/others 
and public authorities, highlighted the need to bridge the gap between research and industry in 
Europe’s  biotechnology  ecosystem.  They  expressed  concerns  on  the  barriers  faced  in 
incubation  and  acceleration,  such  as  funding  gaps  in  early  stages,  a  fragmented  support 
landscape,  regulatory  burdens,  hindrances  in  public-private  collaboration  and  cultural/skill 
barriers.  Business  associations’  and  public  authorities’  feedback  was  in  line  with  this 
statement,  underlining  that  the  EU  lacks  cohesive  pathways  to  commercialisation.  Large 
companies specifically pointed out the lack of financial and administrative capacity of SMEs 
and start-ups to access EU-level funding or to protect their intellectual property. 

Stakeholders overall recognised the pivotal role of AI and data to advance biotechnology. As 
part  of  the  challenges  faced  however,  academic/research  institutions  and  large  companies 
indicated  a  lack  of  access  to  data  and  secure  data  sharing,  fragmented  data  ecosystems 
including  limited  data  interoperability,  unclarity  on  data  governance  and  insufficient 
coordination.  Business  associations  and  public  authorities  also  mentioned  fragmented 
computing  power  and  uneven  access  to  testing  infrastructures.  Furthermore,  SMEs 

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referred to a lack of information and knowledge among companies about AI implementation 
and  compliance.  Feedback  from  NGOs/others  overall  echoed  these  statements,  while  also 
advocating  to  take  into  consideration  the  environmental  impact  of  AI  infrastructures.  Most 
stakeholders additionally pointed out regulatory fragmentation, technical and legal barriers, 
innovation barriers, and governance gaps. AI skills shortages were also mentioned by several 
stakeholder groups, as well as ethical uncertainties. 

stakeholders  mentioned 

Finally,  on  biosecurity, 
that  while  biotechnology  and 
biomanufacturing  offer  transformative  opportunities  across  multiple  application  areas,  these 
must be governed by policies that balance innovation with safety, equity, and environmental 
protection. Various challenges were pointed out by different stakeholder groups in relation to 
biosecurity.  For  instance,  academic/research  institutions,  NGOs  and  public  authorities 
mentioned  a  fragmented  biosecurity  governance  and  regulatory  complexity  as  major 
issues.  Specifically,  disjointed  EU  and  national  regulations  that  hinder  coherent  biosecurity 
frameworks  were  highlighted.  Public  authorities  furthermore  indicated  limited  collaboration 
as a key challenge – for instance gaps in cooperation between national authorities and limited 
cross-border collaboration. Regarding nucleic acid screening, academic/research institutions, 
and NGOs mentioned inconsistent compliance in screening due to current voluntary systems 
as a threat to biosecurity. Finally, dual-use risks were mentioned by SMEs and NGOs. 

A public consultation 50 was carried out from 4 August to 10 November 2025. A total of 359 
contributions  were  received.  No  duplicates  or  campaigns  were  identified.  The  contributions 
considered  for  the  analysis 51  were  submitted  by  91  companies/businesses  and  61  business 
associations,  47  NGOs,  44  academic/research  institutions,  54  EU  citizens  and  9  non-EU 
citizens, and 21 public authorities. A further 2 contributions were submitted by 2 trade unions, 
2  consumer  associations,  and  1  by  an  environmental  organisation 52,  while  27  additional 
respondents identified themselves as ‘Other’. 

50 

51 
52 

European  Commission  ‘Have  your  say’  website:  https://ec.europa.eu/info/law/better-regulation/have-
your-say/initiatives/14627-Biotech-Act/public-consultation_en  
Four trade unions were analysed under business associations. 
In  the  statistics,  the  2  trade  unions,  2  consumer  organisations  and  the  environmental  organisation  are 
reflected with the respondents who identified themselves as ‘other’. 

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16 

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Figures 5 and 6: submissions to the public consultations and industry submissions per 
company size 

Concerning the industry sector, most of the contributions came from SMEs (53 in total out 
of which 12 medium-, 17 small-, and 24 micro-sized SMEs) and 38 contributions came from 
large enterprises. Of the contributing public authorities, 8 had a national remit and 8 had a 
regional scope, 2 of them were local authorities and 3 were international organisations.  

As  part  of  all  contributions  received,  16  respondents  identified  as  private  investors, 
including 13 from the EU and 3 from outside of the EU (Switzerland and the UK). Most of 
them  identified  as  company/business.  When  asked  about  the  type  of  investment  they 
provided, 8 stated that they provided ‘Venture capital’, 5 chose ‘Business Angel’, 4 ‘Private 
equity’, 3‘Corporate Venture Capital (CVC)’, and 1 ‘Other’.  

Lastly, 43 respondents of all contributions received indicated being part of a cluster or of a 
cluster organisation. These represented 26 companies/businesses, 15 business associations, 1 
NGO and 1 ‘Other’. 

There  is  a  strong  overall  interest  from  stakeholders  to  the  biotechnology  sector  and 
acknowledgment  of  its  great  potential,  in  line  with  the  EU’s  economic,  social  and 
environmental  policy  goals.  More  precisely,  a  strong  majority  of  respondents  agreed  that 
biotechnology and biomanufacturing products could positively impact the EU’s economy and 
the  society,  also  recognizing  its  contribution  to  the  environment 53.  Respondents  considered 
biotechnology  and  biomanufacturing  products  that  reached  the  EU  market  to  be  safe  and 
secure 54.  However,  they  did  not  consider  that  information  to  users  and  consumers 55  on 
biotechnology  and  biomanufacturing  products  in  the  EU  was  sufficiently  accessible  and 
broadly communicated. Moreover, only a minority of respondents were willing to pay a price 
premium for such products56. 

Answers to the public consultation  on the EU regulatory framework were in line with the 
focus  of  the  proposed  Act.  The  main  regulatory  barriers 57  identified  by  stakeholders 
concerned  the  assessment  and  obtaining  authorisation  to  market  products,  followed  by 
the pre-commercial testing or clinical trials stage, in commercialising products as well as 
in the scaling-up production or manufacturing and product development.  

Another  finding  of  the  public  consultation  relates  to  the  perception  of  the  EU  regulatory 
environment  compared  to  that  of  some  countries  outside  the  EU.  The  EU  regulatory 
environment is perceived by some stakeholders to have a lower level of predictability58 and 
it  is  also  seen  as  more  complex  and  unclear 59,  leading  to  more  compliance  costs 60  and 

53 
Positive economic impact: 90.3% strongly agreed/agreed (324/359); Positive social impact: 89.7% 
strongly agreed/agreed (322/359); Positive environmental impact: 80.2% strongly agreed/agreed (288/359) 

54 
55 
56 
57 
58 
59 

76.3%: 175 strongly agreed, 99 agreed (out of 359). 
28.1%: 30 strongly agreed, 71 agreed (out of 359). 
15.6%: 13 strongly agreed, 43 agreed (out of 359). 
Agreement/strong agreement on these barriers ranged from 63% to 76%. 
More predictable: 40.8%: 45 strongly disagreed/92 disagreed (out of 336). 
Less complex and clearer: 64.6%: 99 strongly disagreed/116 disagreed (out of 333). 

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slower access to the market 61. Views on whether the EU regulatory environment ensures a 
higher level  of safety and security  were rather  mixed 62. Public authorities (57,9%, 11/19), 
NGOs (46,5%, 20/43), other stakeholders  (48,5%, 15/31) and academic/research institutions 
(42,9%, 18/42) had a positive stance. 

These  findings  underscore  the  urgent  need  to  take  action  to  simplify  and  streamline  the 
regulatory  environment,  making  it  flexible  and  innovation-friendly  so  that  biotechnology 
products and services can reach the EU market more quickly. 

Furthermore, respondents reported low level of access to private investments in the EU, in 
particular in accessing to publicly listing, private equity, debt financing, venture capital (VC) 
across series B (expansion stage) and C (growth stage) and capital markets/shareholders 63. It 
should  be  noted  that  stakeholders  also  expressed  low  level  of  accessibility  to  some  public 
funding,  especially  for  support  for  capacity  expansion,  debt/equity  instruments,  and 
commercialisation  support64.  Stakeholders  indicated  less  difficulties  in  accessing  strategic 
research  or  sales  partnerships/collaborations,  angels,  venture  capital  at  start-up/early-stage 
(series A) and corporate funding 65 and public grants and subsidies 66. 

When  asked  about  the  factors  driving  forward  investments  in  a  biotechnology  company, 
there  were  no  major  differences  in  the  answers.  Some  factors  scored  highly,  which  are  (i) 
groundbreaking  technology;  (ii)  regulatory  certainty;  (iii  innovative  science;  (iv)  scientific 
evidence;  (v)  experienced  management  team;  and  (vi)  sufficient  protection  of  intellectual 
property rights 67. 

On  clusters,  the  five  main  barriers  faced  by  EU  biotechnology  clusters  and/or  cluster 
organisations  preventing  them  from  reaching  their  full  potential  were  identified  as:  (i) 
insufficient financial support; (ii) insufficient public support; (iii) incapacity to reach a critical 
mass  of  stakeholders;  (iv)  insufficient  start-up  incubators  or  business  support  infrastructure; 
and (v) insufficient collaboration among existing clusters68.  

Stakeholders identified the main challenges impacting the EU biomanufacturing sector as: (i) 
global competition; (ii) length and/or complexity of permitting processes for new facilities; 
(iii) difficulty of scaling up from pilot to industrial production; (iv) high energy costs; and 
(v)  the  high  cost  of  raw  material  and/or  of  the  operations69.  A  majority  of  respondents  also 
agreed  that  major  challenges  are  also  posed  by  the  inconsistent  environmental  and 
sustainability policies, vulnerabilities in the supply chains and other operational costs70.  

60 

61 

62 

63 
64 
65 
66 
67 
68 
69 
70 

Leads to lower costs for complying with the regulation: 62%: 98 strongly disagreed/109 disagreed (out 
of 334). 
Enables biotechnology and biomanufacturing products to reach the market faster: 65.7%: 126 strongly 
disagreed/92 disagreed (out of 332) 
Ensures  a  higher  level  of  safety  and  security:  21.4%  disagreed/strongly  disagreed.  (72/337)  36.8% 
agreed/strongly agreed (124/337). 41.8% were neutral or Not applicable/I don’t know (141/337). 
Agreement/strong agreement that there is easy access to these options ranged from 3.9% to 6.7%. 
Agreement/strong agreement that there is easy access to these options ranged from 4.2% to 5.6%. 
Agreement/strong agreement that there is easy access to these options ranged from 11.4% to 21.2%. 
Agreement/strong agreement that there is easy access was 19.2% (69/359). 
Agreement/strong agreement on these factors ranged from 72.4% to 79.9%. 
Agreement/strong agreement on these barriers ranged from 46.2% to 58.5%. 
Agreement/strong agreement on these challenges ranged from 58.2%% to 66.9%. 
Agreement/strong agreement on these challenges ranged from 50.1% to 51.5%. 

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The  public  consultation  also  confirmed  the  challenges  faced  by  the  EU  workforce. 
Stakeholders’  views  were  aligned  on  three  main  challenges:  (i)  the  limited  financial, 
entrepreneurial  skills  and  mindsets;  (ii)  the  insufficient  regulatory  and  quality  assurance 
expertise; and (iii) the shortage of vocational skills71.  

Some stakeholders indicated having difficulties accessing or using data for the development 
of  biotechnology  or  biomanufacturing  products72.  Stakeholders  also  emphasised  that 
technological challenges and challenges in the implementation of regulatory frameworks were 
the  main  barriers  to  both  the  use  of  AI  in  R&D73  and  to  the  deployment  of  AI-based 
biotechnology  products74.  When  asked  about 
types  of  support  needed  for 
biotechnology  companies,  in  particular  for  SMEs,  stakeholders  stressed  (i)  skills 
development  and AI training; (ii)  access  to  annotated datasets;  (iii) partnerships with  public 
research  institutions  or  AI  hubs/factories;  (iv),  dedicated  funding  instruments;  and  (v) 
regulatory sandboxes for testing biotech-related AI models75. 

the 

When  it  comes  to  the  application  of  biotechnology  in  defence  and  security,  the  main 
challenges  identified  by  stakeholders  were:  (i)  the  risks  to  strategic  autonomy  in 
biomanufacturing  (and  availability  of  medical  and  non-medical  countermeasures);  (ii) 
cybersecurity risks to biotechnology infrastructure and AI tools used in biotechnology; (iii) 
vulnerabilities  in  the  resilience  of  biotechnology  supply  chains;  and  (iv)  threats  related  to 
biosecurity and biosafety including misuse of biotechnology76. The four main opportunities 
that biotechnology for defence and security were creating were: (i) to develop new innovative 
medical countermeasures; (ii) to facilitate detecting biological and chemical threats, (iii) 
to  increase  food  security;  and  (iv)  to  develop  materials  with  new  functions  and  /  or 
improved characteristics77. 

In addition, targeted consultation activities were carried out, as detailed below, including in 
the context of an external study announced in the Commission Communication ‘Building the 
future with nature: Boosting Biotechnology and Biomanufacturing in the EU’ (Action 1)78. 

First, the following consultation activities took place on the analysis of  regulatory problems 
and challenges faced by the biotechnology sector and on the mapping of applicable EU and 
national legislations to biotechnologies: 

• 

• 

71 
72 

73 

74 

75 
76 
77 
78 

survey for public authorities; 

survey  for  other  stakeholders,  including  industry  representatives  and  patient 
organisations;  

Agreement/strong agreement on these challenges ranged from 51.8% to 58.5%. 
21.4% replied partially (77/359) and 18.4% replied Yes (66/359) totalling 39.8%. However 44% replied 
Not applicable/I don’t know (158/359 answers) and 16.2% replied No (58/359). 
Technological  challenges:61.3%%:  65  strongly  agreed/155  agreed  (out  of  359);  challenges  in  the 
implementation of regulatory frameworks: 59.1%: 81 strongly agreed/ 131 agreed (out of 359). 
Technological  challenges:51.5%:  63  strongly  agreed/122  agreed  (out  of  359);  challenges  in  the 
implementation of regulatory frameworks: 52.1%: 81 strongly agreed/106 agreed (out of 359). 
Agreement/strong agreement on the needed types of support ranged from 59.1% to 65.5%  
Agreement/strong agreement on the four main challenges ranged from 42.3% to 51.5% 
Agreement/strong agreement on the three main opportunities ranged from 43.7% 48.2%. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the  Committee of the Regions, Building the  future with nature: 
Boosting Biotechnology and Biomanufacturing in the EU, COM(2024) 137 final. 

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• 

• 

interviews with representatives of SMEs and large enterprises, and representatives of 
the spin-off, alliance/platform, scale-up and EU association sectors;  

five  thematic  workshops  covering  (i)  health/pharma;  (ii)  agriculture/environment; 
(iii) food and feed; (iv) bio-based chemicals and plastics; and (v) bio-based materials. 

Second, to analyse the impacts of identified policy provisions, evidence was collected on the 
impacts of these provisions.  

On clinical trials, evidence has been collected (by November 2025) through: 

• 

• 

• 

three workshops organised by the European Commission in June, September, and 
November 202579, with  representatives of national competent  authorities and ethics 
committee  members  from  across  the  EU  to  exchange  views  with  experts  to  inform 
how policy options would be defined; 

targeted interviews;  

targeted survey to various stakeholder groups:  

• 

• 

• 

a survey targeted to sponsors and clinical research organisations received 
48 responses 80.  

another  targeted  survey  collected  views  from  44  public  authorities 
representing 25 EU/EEA countries81. 

a  survey  tailored  to  patient  representatives  received  1  response  from  a 
disease-specific patient representing an organisation at national level. 

Evidence on the impacts of options on genetically modified microorganisms was collected 
through 25 interviews (by November 2025). 

Finally, targeted consultation activities were also conducted as part of the supporting study 
for the evaluation of EFSA. 

• 

Collection and use of expertise  

The major competitiveness gap in biotechnology and the market and regulatory barriers faced 
by  European  companies  were  identified  in  the  Commission  Communication  ‘Building  the 
future  with  nature:  Boosting  Biotechnology  and  Biomanufacturing  in  the  EU’82  and  in  the 
Draghi83 and Letta84 reports. 

79 

80 

81 

82 

83 

CTAG: Clinical Trials Advisory Group; MedEthics-EU, the Clinical Trials Coordination Group of  the 
Heads of Medicines Agencies (HMA) was also invited to the workshop. The EMA is an observer to the 
CTAG. 
32  from  commercial  sponsors,  6  from  non-commercial  sponsors,  3  from  Clinical  Rresearch 
Organisations  (CROs),  and  7  from  other  stakeholders  such  as  non-profits,  hospital  owners,  advocacy 
groups, research infrastructures, trade associations and life sciences providers 
20  responses  from  ethics  committees,  20  from  national  competent  authorities,  3  from  ministries  or 
government bodies, and 1 from a respondent identified as both a ministry and an ethics committee 
 Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the  Committee of the Regions, Building the  future with nature: 
Boosting Biotechnology and Biomanufacturing in the EU, COM(2024) 137 final. 
Draghi,  Mario.  The  future  of  European  competitiveness:  A  competitiveness  strategy  for  Europe, 
European Commission, 9 September 2024. 

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In addition, the above-mentioned external study commissioned by the European Commission 
(‘Analysis of the Regulatory Framework for Biotechnology and Biomanufacturing in the 
EU’)  provides  an  extensive  mapping  of  the  main  pieces  of  EU  and  national  legislation  that 
apply  to  biotechnology  and  biomanufacturing  products  and  processes  –  whether  they  are 
horizontal or sector-specific – and identifies the challenges, their causes and the consequences 
for  stakeholders.  The  study  also  assesses  the  impacts  of  policy  options  related  to  the  EU 
regulatory framework. 

• 

Impact assessments 

Considering the politically urgent need to address the policy challenges identified, an impact 
assessment  could  not  have  been  delivered  in  the  timeframe  available  before  the  proposal’s 
adoption.  Instead,  an  analytical  staff  working  document  (SWD)  will  be  prepared.  The 
analytical SWD will explain the proposal and will present the underlying evidence and impact 
analysis,  including  cost-benefit  analysis.  A  large  number  of  provisions  of  the  proposal 
concern  simplification  measures  which  typically  do  not  offer  viable  alternatives  and  do  not 
modify  the  objectives  of  the  amended  legislation.  Nevertheless,  the  proposed  measures  are 
based on extensive  stakeholder consultations,  complemented with  an  analysis  of the  current 
situation to ensure a transparent, proportionate, and evidence-based approach.  

• 

Regulatory fitness and simplification 

The  proposal  lays  down  measures  to  strength  the  EU  biotechnology  and  biomanufacturing 
ecosystem and reduce time-to-market for biotechnology products in the EU.  

The  proposed  Act  aims  to  simplify  the  existing  regulatory  framework  and  remove 
regulatory burdens  hampering  the  innovation and competitiveness of EU operators.  In 
particular,  the  measures  seek  to  clarify  and  reduce  procedural  timelines  across  the  full 
development  cycle  (e.g.  by  alleviating  complex  and  disproportionate  requirements)  and 
provide a  flexible  regulatory environment for a  fast-growing innovative sector (e.g. through 
regulatory sandboxes and by enabling an increasing use of data and AI). As such, all actors, in 
particular  companies,  will  benefit  from  a  more  predictable  EU  regulatory  framework,  i.e. 
increased  legal  certainty,  reduced  procedural  timelines,  and  a  flexible  and  collaborative 
regulatory  environment.  Overall,  these  measures  are  expected  to  enable  companies  to  bring 
innovation  to  the  market.  SMEs  in  particular  are  expected  to  benefit  from  these  measures 
through  reduced  entry  barriers  in  the  field  of  biotechnology.  The  supporting  measures  also 
target the needs of SMEs, start-ups and scale-ups. 

National and regional authorities will benefit from streamlined, more coherent procedures 
and  improved  coordination,  reducing  duplication  of  work,  and  supporting  more  consistent 
regulatory decisions across the Union.  

The proposed measures are targeted amendments that preserve the objectives of the existing 
regulations  to  maintain  and  safeguard  a  high  level  of  protection  of  health  and  the 
environment.  Similarly,  measures  to  prevent  the  misuse  of  biotechnologies  and  strengthen 
EU biodefence capabilities, including monitoring AI-enabled biological risks, will ensure that 
innovation is accompanied by robust safeguards for public health and security. 

84 

Enrico  Letta  (2024),  Much  more  than  a  Market.  Enrico  Letta  -  Much  more  than  a  market  (April 
2024)https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-
letta.pdf  

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Furthermore,  EU biotechnology businesses, and  in  particular those with the potential  to  be 
transformative  for  the  biotechnology  ecosystem  are  expected  to  have  improved  access  to 
capital  throughout  the  different  stages  of  their  development  and  better  access  to  the 
infrastructure needed to assess the industrial potential of their innovation, thus contributing to 
a thriving biotechnology and biomanufacturing ecosystem in the EU. Strategic biotechnology 
projects, which the proposal aims to foster, may also include activities addressing the growing 
skills  gap  in  biotechnology  and  biomanufacturing  and  are  expected  to  contribute  to  a 
workforce  capable  of 
long-term 
innovation, 
competitiveness. Investors and financial intermediaries will benefit from a more predictable 
pipeline  of  projects  and  clearer  regulatory  certainty,  supporting  greater  availability  of  risk-
tolerant capital in the EU. 

scale-up  and 

supporting 

industrial 

The initiative will foster, in  line with  the Union  policy and legislation on  AI, the use of  AI 
across  the  biotechnology  ecosystem,  giving  companies  –  and  more  particularly  SMEs  – 
more  guidance  and  opportunities  to  integrate  trustworthy,  high-quality  AI  solutions  into 
research, testing and production processes. 

End-users,  including  patients  and  citizens  will  benefit  from  biotechnology  products  that 
meet their needs. Faster time-to-market and, improved clinical-trial performance are expected 
to  result  in  earlier  access  to  safe,  effective,  high-quality  and  affordable  biotechnology 
products, 
innovative 
biomanufactured products which will also benefit healthcare systems. 

therapies,  diagnostics,  biosimilars  and 

including  advanced 

Overall, these targeted measures combined are expected to (i) facilitate the growth of the EU 
biotechnology  and  biomanufacturing 
the  global 
industry 
competitiveness  and  innovation  capacity  of  the  EU’s  biotechnology  companies;  and  (iii) 
increase the EU’s strategic autonomy in critical technological areas.  

the  EU;  (ii) 

improve 

in 

• 

Fundamental rights 

The  Act  respects  the  fundamental  rights  and  principles  laid  down  in  the  Charter  of 
Fundamental Rights of the European Union85.  

The  proposed  measures  simplifying  EU  legislation  and  the  new  initiatives  on  EU  industrial 
policy  are  expected  to  contribute  to  the  smooth  functioning  of  the  internal  market  and,  in 
particular,  support  the  freedom  to  conduct  a  business  (Article  16  of  the  Charter).  The 
measures  under  this  proposal  seek  to  enable  innovation,  expand  the  EU’s  manufacturing 
capacity  and  clarify  procedures  for  biotechnologies  to  reach  the  market.  The  proposed 
measures will also ensure a high level of human health protection and will enhance the right 
of access to preventive healthcare and the right to benefit from medical  treatment under the 
conditions laid down by national laws and practices, as provided in Article 35 of the Charter. 
Similarly, the proposal will help ensure a high level of environmental protection and improve 
the quality of the environment, in line with Article 37 of the Charter. 

4. 

BUDGETARY IMPLICATIONS  

Without  prejudice  to  the  outcome  of  the  negotiations  on  the  next  Multiannual  financial 
framework (MFF) proposal, strategic health biotechnology projects and high-impact strategic 

85 

EN 

Charter 
ELI: http://data.europa.eu/eli/treaty/char_2012/oj 

Fundamental 

of 

Rights 

of 

the 

European 

Union, 

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biotechnology  projects  may  be  supported  by  Union  programmes,  funds  and  instruments,  in 
accordance  with  the  objectives  set  out  in  the  regulations  establishing  those  funds  and 
programmes. A  contribution is expected to come from the “health, biotechnology, agriculture 
and bioeconomy” window under the European Competitiveness Fund which, according to the 
proposal  of  the  Commission,  would  receive  a  total  allocation  of  EUR  20.4  billion  over  the 
MFF 2028-2034. Two  agencies, EMA and EFSA are proposed to  be reinforced in  staff  and 
financially to conduct tasks related to these projects. The necessary financial resources will be 
compensated  from  applicable  programmes  under  the  agencies'  headings  in  the  2028-2034 
MFF  and  where  possible  by  additional  income  to  be  generated  from  third  parties.  The 
Legislative Financial and Digital Statement (LFDS) also presents estimated budgetary impact 
under Heading 4 including related human and administrative resources. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements  

In  the  short  term,  implementation  will  focus  on  completing  the  strategic  mapping  of  the 
Union’s biotechnology ecosystem within six months of the Regulation’s entry into force, and 
on  setting  up  the  new  governance  and  support  structures,  including  the  EU  Health 
Biotechnology Support Network, the Foresight Panel for Emerging Health Innovation and the 
European Health Biotechnology Steering Group. To support Member States in implementing 
the Regulation, to promote a uniform application of the Regulation and to clarify technical or 
operational elements where needed, the Commission may issue guidance on specific matters, 
including  the  criteria  and  procedures  for  recognising  strategic  health  biotechnology  projects 
and high-impact health biotechnology strategic projects, and the coordination between the EU 
Health Biotechnology Support Network and other relevant networks. Member States will be 
required  to  designate  national  single  points  of  contact  and  begin  applying  the  streamlined 
regulatory procedures. 

Monitoring will rely on the strategic mapping as a continuous evidence base, complemented 
by  regularly  updated  information  on  the  list  of  strategic  health  biotechnology  projects  and 
high-impact health biotechnology projects.  

In  the  medium  term,  the  strategic  mapping  of  the  biotechnology  ecosystem  will  be  updated 
periodically and used to inform project selection and guide the deployment of Union support. 
Five  years  after  the  Regulation’s  entry  into  application,  and  every  five  years  thereafter,  the 
Commission will evaluate the Regulation’s effectiveness and impact, and report its findings to 
the European Parliament, the Council, the European Economic and Social Committee and the 
Committee of the Regions. 

• 

Detailed explanation of the specific provisions of the proposal  

Chapter I – Subject Matter, Scope and Definitions 

This  Chapter  sets  out  the  subject  matter  of  this  proposal,  which  consists  of  measures  that 
articulate  its  overall  objective  (i)  to  improve  the  functioning  of  the  internal  market  by 
establishing a framework to strengthen the competitiveness of the biotechnology sector, from 
research to production, (ii) to create the conditions for the development and timely placing on 
the  Union  market,  of  biotechnology  innovations,  products  and  services,  (iii)  while 
safeguarding  high  standards  for  the  protection  of  human  health,  animal  health,  patients  and 
consumers,  the  environment,  ethics,  quality,  food  and  feed  safety,  and  biosecurity.  This 
Chapter  also  specifies  the  scope  of  the  proposal,  which  applies  to  health  biotechnology 

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products  and  services  during  their  entire  lifecycle,  including  related  activities  on  research, 
funding,  development,  innovation,  testing,  validation,  manufacturing,  placing  on  the  market 
and  use.  Lastly,  this  Chapter  establishes  definitions  for  key  terms  used  throughout  the 
proposal, 
including  ‘biotechnology’,  ‘health  biotechnology’,  ‘biotechnology  product’, 
‘biotechnology service’ and ‘biomanufacturing’.  

Chapter II – Union health biotechnology and biomanufacturing 

to  boost  Europe's  competitiveness  and  resilience 

This  Chapter  introduces  the  concepts  of  health  biotechnology  strategic  projects  and  high 
impact health biotechnology strategic projects and establishes a framework for the recognition 
and the support of such projects aimed at strengthening the EU’s industrial biomanufacturing 
capacity and value chains. Strategic projects  should mobilise and focus action at  Union and 
Member State level,  including  on public and private investments  and accelerated permitting 
and  other  support  measures, 
in 
biotechnology.  To  build  a  strong  EU  biotechnology  ecosystem,  provisions  are  included  to 
encourage  pro-competitive  collaboration  between  projects,  networks  and  clusters.  These 
measures  are  to  be  underpinned  by  a  strategic  mapping  of  the  Union’s  biotechnology 
ecosystem  to  identify  capacities,  gaps,  dependencies  and  investment  needs,  thereby  guiding 
the  prioritisation  of  strategic  and  high-impact  projects  and  informing  Union  policy  and 
funding decisions. This Chapter also sets up an EU health biotechnology support network of 
national and regional antennas to support biotechnology projects and innovators in navigating 
identifying 
regulatory  procedural  pathways  relevant 
opportunities  for  funding,  scaling  up  and  networking,  leveraging  and  complementing  the 
activities of existing national and European networks that support SMEs, start-ups and scale-
ups, and innovators. 

to  health  biotechnologies  and 

Finally,  this  Chapter  establishes  the  European  Health  Biotechnology  Steering  Group, 
composed  of  representatives  of  Member  States  and  the  Commission  and  its  tasks,  which 
include  facilitating  communication  among  Member  States,  the  Commission,  and  various 
stakeholders to ensure biotechnology projects are recognised and implemented effectively. 

Chapter III – Access to funding 

This Chapter establishes an EU health biotechnology investment pilot in partnership with the 
European  Investment  Bank  Group  and  other  implementing  partners,  which  brings  together 
equity  instruments  and  venture-style  debt  tailored  to  biotechnology-specific  risk  profiles,  in 
order to mobilise private investment into the sector. Projects contributing to an EU late-stage 
Capital  Booster  Pilot  will  be  recognised  by  the  Commission  as  high-impact  strategic  health 
biotechnology  projects.  Companies,  projects  and  initiatives  falling  within  the  scope  of  this 
Regulation  may  be  considered  for  Union  and  Member  State  financial  support,  in  line  with 
applicable State aid rules. 

Chapter IV – Extension of the supplementary protection certificate 

This  chapter  introduces  an  extension  of  12  months  of  the  Supplementary  Protection 
Certificate (SPC) for medicinal products developed by means of biotechnology processes and 
for  Advanced  Therapy  Medicinal  Products.  This  provision  aims  at  incentivising  the 
development  of  products  developed  with  innovative  biotechnology  technologies  which  will 
bring  a  therapeutic  advantage  to  patients.  This  incentive  will  also  support  the  clinical 

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development  and  the  manufacturing  of  these  products  in  the  Union,  subject  to  compliance 
with applicable competition rules. 

Chapter V - Enhancing competitiveness in biosimilars 

This  Chapter  supports  EU  competitiveness  in  the  field  of  biosimilars  by  encouraging  the 
development  of  EMA  guidelines  on  facilitating  the  authorisation  of  biosimilar  medicinal 
products.  This  Chapter  also  includes  measures  supporting  strategic  health  biotechnology 
projects  focused  on  biosimilar  research,  development,  manufacturing  and  marketing 
authorisation  and  promotes  international  cooperation  between  economic  operators  and 
biotechnology  clusters in  this area, subject  to  compliance with  applicable competition  rules. 
Any funding from Member States should be in line with applicable State aid rules.   

Chapter VI – Artificial intelligence and data as biotechnology enablers  

innovation,  efficiency  and 

This  Chapter  aligns  with  the  AI-first  policy  introduced  in  the  Apply  AI  Strategy  and 
encourages the adoption and integration of AI in actions supporting biotechnology, in order to 
foster 
in  biotechnology  and 
biomanufacturing.  It  also  provides  for  guidance  to  be  issued  by  the  EMA  on  the  use  of  AI 
across the medicinal-product lifecycle and creates trusted AI testing  environments and data-
quality accelerators as high-impact strategic health biotechnology projects to advance safe AI-
enabled biotechnology.  

technological  sovereignty 

Chapter VII – Regulatory tools for novel health biotechnology products  

This  Chapter  sets  out  a  flexible,  collaborative  and  anticipatory  approach  to  regulate  novel 
health  biotechnology  products  by  reinforcing  and  complementing  existing  mechanisms  in 
Union law, notably (i) those introduced in the revised Directive 2001/83/EC on the interaction 
and  combinations  between  medicinal  products  and  medical  devices,  and  on  regulatory 
sandboxes;  and  (ii)  the  mechanisms  provided  under  the  [revised]  MDR,  IVDR,  the  revised 
Pharmaceutical  Regulation  and  the  SoHO  Regulation,  which  allow  for  the  provision  of 
opinions,  recommendations  or  binding  decisions  on  the  regulatory  status  of  products.  This 
Chapter  lays  down  a  Union-wide,  cross-framework  regulatory  status  repository,  which  will 
compile  relevant  opinions,  recommendations,  decisions  and  guidance,  thus  fostering 
transparency,  consistency  and  mutual  learning  across  Union  and  national  authorities. 
Recognising the need for anticipatory governance, this Chapter also sets up a foresight panel 
for  emerging  health  innovation  to  advice  the  Commission  and  conduct  structured  horizon-
scanning  and  cross-framework  dialogue  on  forthcoming  scientific  and  technological 
developments. Lastly, this Chapter provides for the establishment of a Union level regulatory 
sandbox for health biotechnology products at an early stage of development that fall outside 
existing health legal frameworks.  

Chapter VIII – Biodefence and preventing biotechnology misuse 

This Chapter establishes a framework for preventing the misuse of biotechnology products of 
concern.  It  includes provisions for screening,  reporting, and tracking  suspicious transactions 
of  biotechnology  products  of  concern,  and  enforcement  mechanisms  to  ensure  compliance. 
This  Chapter  sets  out  specific  conditions  for  the  Commission  to  recognise  high-impact 
strategic health biotechnology projects in the form of EU biodefence capability projects, that 
may  be  given  particular  consideration  for  funding  under  Union  basic  acts,  subject  to 
compliance with applicable State aid rules. Ultimately, the Regulation seeks to promote a high 

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level  of  protection  against  biotechnological  threats,  while  fostering  innovation  and 
competitiveness in the biotechnology sector. 

Chapter IX –  Amendments to Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) 
No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 

This Chapter introduces amendments to EU legislative frameworks in the areas of health and 
food and feed safety with the aim of simplifying procedures and accelerating time to market 
that are necessary to ensure the effectiveness of the substantive provisions established in this 
proposal  by  creating  legislative  frameworks  conducive  to  innovation.  Further,  it  establishes 
amendments to Regulation (EU) 2024/795 (STEP Regulation)86 regarding the status of health 
biotechnology  strategic  projects  and  of  high  impact  health  biotechnology  strategic  projects 
under that Regulation.  

Amendments to Regulation (EC) No 178/2002 (General Food Law)  

This  Regulation  proposes  amendments  to  Regulation  (EC)  No  178/200287  laying  down  the 
general  principles  and  requirements  of  food  law,  in  order  to  streamline  risk  assessment 
processes.  Key  changes  include  (i)  broadening  pre-submission  advice  to  include  scientific 
matters, such as study design and testing strategies, while merging it with the renewal-related 
advice into a single, unified procedure to simplify application procedures; (ii) shortening the 
procedural  delay  for  non-compliance  with  the  study  notification  requirements  at  pre-
submission  phase  from  six  to  three  months  to  reduce  time-to-market;  (iii)  requiring  EFSA 
staff  to  chair  panels  and  serve  as  vice-chairs  of  the  Scientific  Committee  (without  voting 
rights) to improve efficiency and coherence across Panels; and (iv) introducing provisions for 
regulatory  sandboxes,  allowing  Member  States  to  test  innovative  technologies  under 
harmonised conditions that foster innovation while safeguarding consumer health and safety. 
Such  amendments  should  contribute,  amongst  others,  to  accelerating  the  risk  assessment 
process  carried  out  by  EFSA  for  products  that  are  subject  to  pre-market  authorisation  in 
accordance with Union food and feed law and foster innovation in the sector. As such, those 
are necessary amendments with a view to ensure the effectiveness of the substantive measures 
put forward in this proposal towards the strengthening of an innovative biotechnology sector 
in food and feed safety. 

Amendments  to  Regulation  (EC)  No  1394/2007  (Advanced  Therapy  Medicinal  Products 
Regulation) 

To  speed  up  access  to  advanced  investigational  therapy  medicinal  products  that  consist  or 
contain  GMOs  that  are  complex  innovative  products,  this  Regulation  proposes  special 
provisions  for  facilitating  related  clinical  trials.  In  this  regard,  it  is  proposedto  amend 
Regulation  (EC) No 1394/2007  to  provide that when controlling  under Regulation  (EU) No 
536/2014 for risks from the deliberate release into the environment of GMOs, sponsors are to 

86 
Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 
establishing  the  Strategic  Technologies  for  Europe  Platform  (STEP),  and  amending  Directive 
2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, 
(EU)  No  223/2014,  (EU)  2021/1060,  (EU)  2021/523,  (EU)  2021/695,  (EU)  2021/697  and  (EU) 
2021/241, ELI: http://data.europa.eu/eli/reg/2024/795/oj 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority  and  laying  down  procedures  in  matters  of  food  safety,  OJ  L  31,  1.2.2002,  pp.  1–24.  ELI: 
http://data.europa.eu/eli/reg/2002/178/oj 

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be exempted from the requirement to submit an environmental risk assessment in respect of 
certain  clearly  delineated  categories  of  advanced  investigational  therapy  medicinal  products 
that  consist  or  contain  GMOs  which  present  no  or  negligible  risks  to  human  health  and  the 
environment.  Sponsors  of  clinical  trials  are,  however,  to  submit  a  declaration  as  part  of  the 
clinical  trial  application  that  explains  why  the  advanced  investigational  therapy  medicinal 
products concerned fall into one or more of the specific categories of products presenting no 
or  negligible  risks  to  human  health  and  the  environment.  The  Committee  for  Medicinal 
Products  for  Human  Use  (CHMP)  referred  to  in  Article  [148]  of  Regulation  […]  [revised 
Regulation No (EC) 726/2004] is to verify this declaration. For the same considerations of a 
risk-proportionate  approach,  this  Regulation  also  proposes  that  the  above-mentioned 
categories  of  advanced  investigational  therapy  medicinal  products  be  exempted  from  the 
GMO  related  requirements  of  Regulation  (EU)  No  536/2014  regarding  manufacturing  and 
import.  

Scientific  and  technological  advances  are  driving  forward  the  development  of  ATMPs.  To 
future-proof  the  ATMP  regulatory  framework  and  ensure  that  it  can  encompass  certain 
innovative products that could benefit from the ATMP framework, without them falling under 
other EU legal frameworks, the [revised Directive 2001/83/EC] empowers the Commission to 
adopt  delegated acts  to  amend the definitions laid down in  the ATMP Regulation  of a gene 
therapy  medicinal  product  and  a  somatic  cell  therapy  medicinal  product,  without  extending 
the scope of these  definitions. It  should be also  possible to  amend the definition of a tissue 
engineered product in the light of technical and scientific advancements.  

Amendments to Regulation (EU) No 536/2014 (Clinical Trials Regulation)  

This  Chapter,  critical  to  improving  Europe’s  clinical-trial  framework,  aims  to  cut  approval 
timelines,  foster  greater  collaboration  across  borders,  and  improve  regulatory  efficiency, 
without compromising safety, quality, or ethical standards. Simplification and acceleration of 
procedures are necessary for ensuring the effectiveness of the enabling substantive measures 
put  forward  in  this  proposal.  Authorisation  timelines  will  be  shortened  for  multinational 
clinical trials from 106 days to 75 days, including validation and ethical review. When there is 
no request for information to the sponsor, timelines for initial clinical trial authorisations will 
be reduced from 75 days to 47 days from submission to decision. Given the growing scientific 
and regulatory expertise in ATMPs, the additional 50 days for assessing these products will be 
eliminated. The assessment period for substantial modifications will be reduced from 96 days 
to  47  days,  with  options  for  parallel  substantial  modifications.  If  there  is  no  request  for 
information to sponsor, the timelines for the assessment of substantial modifications  will be 
reduced from 64 days to 33 days from submission till decision. The reporting Member State’s 
role will be strengthened so that it can lead the scientific, ethical, and regulatory assessment 
harnessing  mutual  trust  between  Member  States  and  reliance  on  the  assessment  of  the 
reporting  Member  State.  Communication  between  sponsors  and  Member  States  will  be 
improved during assessments. A single, core dossier for investigational products will simplify 
clinical  trials  using  the  same  investigational  medicine  and  help  the  conduct  of  registration 
trials  and  the  preparation  of  marketing  authorisation  applications  in  Europe.  Simplifications 
for low-intervention clinical trials will be further supported by introducing a new category of 
‘minimal-intervention’  clinical  trials.  Mandatory  EU  harmonised  templates  will  enable 
harmonisation.  A  single  assessment  process  will  be  defined  for  combined  studies  involving 
the investigation of a medicine together with a medical device or an in-vitro diagnostic. The 
legal basis for processing personal data in clinical trials in accordance with Regulation (EU) 
2016/679    requirements  will  be  harmonised.  Accelerated  and  simplified  procedures  will 
enable  multinational  clinical  trials  to  be  carried  out  on  in  relation  to  public  health 

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emergencies. The uptake of the use of AI systems and digitalisation in clinical trials will be 
fostered.  Clinical  trial  sandboxes  will  be  created  to  test  innovative  approaches.  Annex  I  to 
Regulation (EU) No 536/2014 is also amended to ensure consistency with the amendments to 
Regulation  (EC)  No  1394/2007  proposed  in  this  Regulation,  regarding  certain  categories  of 
advanced investigational therapy medicinal products containing or consisting of GMOs.  

Amendments to Regulation (EU) 2019/6 (Veterinary Medicine Products Regulation)  

Biological  veterinary  medicinal  products,  derived  from  living  sources,  have  more  complex 
lifecycle  and  variation  handling  than  chemically  synthesised  medicines.  Regulation  (EU) 
2019/688  introduced  variations  not  requiring  assessment  to  reduce  administrative  burden, 
which will be further optimised in  this section without affecting quality,  safety,  or  efficacy. 
To  cut  administrative  burden  for  innovations,  this  section  foresees  that  the  assessment  of 
human  health  and  environmental  impacts  of  veterinary  medicinal  products  containing 
genetically  modified  organisms  should  be  made  solely  under  the  Environmental  Risk 
Assessment  (ERA)  pursuant  to  Regulation  (EU)  2019/6,  removing  the  need  for  assessment 
under  the  Union  GMO  legislation,  while  reinforcing  obligations  under  Regulation  2019/6. 
The  section  also  clarifies  that  administering  veterinary  medicinal  products  does  not  place 
treated animals or their products under the Union GMO legislation. Also, the Commission is 
empowered to adapt technical requirements in Annex II to Regulation 2019/6 to scientific and 
technical  progress.  Veterinary  medicinal  products  developed  by  means  of  biotechnology 
processes to diagnose, treat or prevent zoonotic diseases are entitled to an extra year of SPC. 
Finally, the introduction of regulatory sandboxes for animal health innovation will allow new 
technologies,  methods,  or  products  to  be  tested,  marketed,  or  used  under  proportionate 
oversight  where  no  specific  EU  legislation  exists,  fostering  responsible  innovation  in 
veterinary medicine 

Amendments to Regulation (EU) 2024/795 (STEP Regulation) 

This  provision  introduce  amendments  to  Regulation  (EU)  2024/795  to  establish  that  health 
biotechnology  strategic  projects,  including  high-impact  health  biotechnology  strategic 
projects recognised in accordance with this Regulation are to be deemed to contribute to the 
STEP  objectives referred to  in  Article 2 paragraph 1, point (a)(iii) or point (b) of the STEP 
Regulation, as appropriate.  

Amendment to Regulation (EU) 2024/1938 (SoHO)  

Substances  of  human  origin  (SoHO)  are  a  key  pillar  of  biotechnology  as  they  can  become 
starting  materials  for  innovative  medicinal  products.  This  section  introduces  a  regulatory 
sandbox  in  the  SoHO  framework.  It  enables  access  to  very  innovative  but  regulatory 
challenging  therapies  and  products  while  generating  insights  that  can  inform  updates  to 
regulatory frameworks, ensuring that they remain flexible, adaptive and fit for purpose in the 
face of evolving scientific and technological advancements.  

Chapter X – Final provisions 

88 

Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  of  11  December  2018  on 
veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance), OJ L 4, 
7.1.2019, pp. 43–167. ELI: http://data.europa.eu/eli/reg/2019/6/oj 

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This Chapter contains provisions on (i) monitoring; (ii) delegation of power; (iii) committee 
procedure, (iv) an obligation for the Commission to prepare regular reports to the  European 
Parliament  and  to  the  Council  for  the  evaluation  of  this  Regulation;  (v)  handling  of 
confidential information, and entry into force and application. 

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2025/0406 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on establishing a framework of measures for strengthening Union’s biotechnology and 
biomanufacturing sectors particularly in the area of health and amending Regulations 
(EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 
and (EU) 2024/1938 (European Biotech Act) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Articles 114, 168(4) and 173(3) thereof,  

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 

Having regard to the opinion of the European Economic and Social Committee,  

Having regard to the opinion of the Committee of the Regions,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

Biotechnology  is  a  strategic  technology  central  for  the  Union’s  competitiveness, 
strategic  autonomy  and  innovation  leadership.  It  has  applications  across  several 
sectors, with prominence in the health area.  In 2021, the Union was the second largest 
contributor  to  the  global  value  of  biotechnologies.  Between  2008  and  2018,  the 
biotechnology  industry  in  the  Union  grew  more  than  twice  as  fast  as  the  overall 
economy,  making  it  one  of  the  fastest  growing  innovative  industries  in  the  Union. 
Health  biotechnology  specifically  contributes  over  80%  to  the  value  of  the  overall 
biotechnology  market  and  it  is  a  key  driver  of  today’s  innovative  medical  industry. 
Biological  medicines,  including  biosimilars  count  for  40%  of  overall  pharmaceutical 
sales in the Union. 

(2)  While  recognised  globally  for  its  scientific  excellence,  the  Union  continues  to  face 
structural  challenges  in  translating  cutting-edge  research  and  innovation  into  large-
scale  development,  testing,  manufacturing  and  deployment  of  biotechnology.  As  a 
result, the significant potential of biotechnology applications across several sectors to 
contribute to major societal challenges, modernise the Union economy and strengthen 
Union strategic autonomy and security remains largely underexploited.  

(3) 

This is due in particular to limited access to risk capital and other sources of funding, 
skills  shortages  within  the  internal  market,  slow  permitting  processes  that  hinder  the 
timely  deployment  of  projects  and  initiatives  aiming  to  bring  biotechnology 
innovations  to  the  market,  as  well  as  fragmented  and  at  times  complex  regulatory 
frameworks.  

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(4) 

(5) 

(6) 

(7) 

To  address  this  competitiveness  gap,  this  Regulation  should  aim  to  improve  the 
functioning  of  the  internal  market  by  establishing  a  framework  to  strengthen  the 
competitiveness  of  the  health  biotechnology  sector  from  research  and  innovation  to 
production, to  create the conditions  for  research,  development, timely placing  on the 
Union  market  and  production  of  health  biotechnology  innovations,  products  and 
services, including by simplifying and streamlining the Union legislative frameworks, 
while  safeguarding  high  standards  for  the  protection  of  human  and  animal  health, 
patients, the environment, ethics, quality, food and feed safety and biosecurity. 

Given  the  importance  of  health  biotechnology  amongst  the  other  applications  of 
biotechnology  as  referred  to  in  recital  (1),  it  is  appropriate  that  this  Regulation 
focusses on, and sets out specific measures for, the health dimension of biotechnology. 
To ensure the effectiveness of this Regulation, its scope of application should extend 
to health biotechnology in a comprehensive manner and cover health within the wide 
meaning of Article 168 TFEU on the protection of public health. 

Article 168(1) TFEU emphasises that a high level of human health protection is to be 
ensured  when  defining  and  implementing  all  Union  policies  and  activities.  Article 
168(4)  TFEU  clarifies  that  this  objective  is,  amongst  others,  to  be  pursued  through 
measures  setting  high  standards  of  quality  and  safety  for  medicinal  products  and 
devices  for  medical  use  and  of  organs  and  substances  of  human  origin,  blood  and 
blood  derivatives, measures in  the veterinary  and phytosanitary fields  which have as 
their direct objective the protection of public health. 

Accordingly, and in line with the One Health approach, that aims to comprehensively 
and sustainably balance and optimise the health of people, animals, and ecosystems1, 
this Regulation should apply to health biotechnology, understood as the application of 
biotechnology  in  the  human  medical,  veterinary,  pharmaceutical  and  phytosanitary 
areas  for  the  development  of  biotechnology  products  and  services.  This  Regulation 
should apply to their entire lifecycle, including the related research, access to funding, 
development, innovation, testing, validation, manufacturing, placing on the market and 
use activities.  

(8)  With a view to ensuring the effectiveness, consistence and unity of some of the legal 
acts  that  this  Regulation  should  amend  to  foster  the  Union’s  competitiveness  in 
biotechnology,  this  Regulation  should  in  certain  cases  also  apply  to  products  and 
activities other than biotechnology products and activities, so as to avoid the creation 
of  different  sets  of  rules  for  biotechnology  and  non-biotechnology  products  and 
activities.  This  is  in  particular  the  case  in  the  area  of  health  for  Union  legislation 
regarding clinical trials, and in the food and feed safety area, for Regulation (EC) No 
178/2002 of the European Parliament and of the Council2.  

(9) 

This Regulation should apply without prejudice to the harmonised legal framework for 
the  development,  the  placing  on  the  market,  the  putting  into  service  and  the  use  of 

1 

2 

European Commission: Group of Chief Scientific Advisors and Directorate-General for Research and 
Innovation, One Health governance in the European Union, Publications Office of the European Union, 
2024, https://data.europa.eu/doi/10.2777/8697309 .  
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority  and  laying  down  procedures  in  matters  of  food  safety,  OJ  L  31,  1.2.2002,  p.  1. 
ELI: http://data.europa.eu/eli/reg/2002/178/oj. 

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artificial  intelligence  (AI),  laid  down  by  Regulation  (EU)  2024/16891689  of  the 
European Parliament and of the Council3. 

(10)  This Regulation should not affect to the application of the Directive 2010/63/EU of the 
European  Parliament  and  of  the  Council4  on  the  protection  of  animals  used  for 
scientific purposes and of Regulation (EC) 2006/1907 of the European Parliament and 
of the Council5.  

(11)  The Union has adopted other initiatives to strengthen the competitiveness of particular 
sectors  of  the  Union  economy.  In  this  regard,  Regulation  (EU)  2024/1735  of  the 
European  Parliament  and  of  the  Council6  focuses  on  clean  and  resource-efficient 
technologies  which  include,  in  particular,  net-zero  technologies.  That  Regulation 
establishes  a framework  to  ensure  the  Union’s  access  to  a secure  and  sustainable 
supply of net-zero technologies listed in Article 4 thereof. Such technologies include 
sustainable biogas and biomethane technologies and biotechnology climate and energy 
solutions. However, as  acknowledged by Regulation (EU) 2024/795 of the European 
Parliament  and  of  the  Council7,  biotechnologies  have  applications  beyond  the  clean 
and  resource-efficient  technologies.  It  is  therefore  appropriate  that  this  Regulation 
applies  without  prejudice  to  the  provisions  of  Regulation  (EU)  2024/1735  regarding 
sustainable biogas and biomethane technologies and biotechnology climate and energy 
solutions. 

(12)  Health  biotechnology  strategic  projects  should  serve  as  targeted  instruments  to 
mobilise public and private investments through coordinated action among the Union, 
the  Member  States,  the  industry,  the  research  community  and  other  relevant  actors. 
They  should  contribute  to  the  Union’s  biotechnology  objectives,  by  strengthening 
industrial  capacity  and  value  chains,  scaling  up  critical  research  and  technology 
infrastructures,  accelerating  innovation  and  technology  deployment  such  as  New 
Approach  Methodologies  (NAMs),  or  advanced  data  and  digital  platforms. 
Accordingly,  this  Regulation  should  lay  down  provisions  for  the  recognition  and 
support of such projects by the Member States  and should establish criteria for such 

3 

4 

5 

6 

7 

Regulation  (EU)  2024/1689  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  laying 
down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 
167/2013,  (EU)  No  168/2013,  (EU)  2018/858,  (EU)  2018/1139  and  (EU)  2019/2144  and  Directives 
2014/90/EU,  (EU)  2016/797  and  (EU)  2020/1828  (Artificial  Intelligence  Act)  (OJ  L,  2024/1689, 
12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj). 
Consolidated  text:  Directive  2010/63/EU  of  the  European  Parliament  and  of  the  Council  of  22 
September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance). 
ELI: http://data.europa.eu/eli/dir/2010/63/2019-06-26 
Consolidated text: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 
December  2006  concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing 
Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (Text with EEA relevance). ELI: http://data.europa.eu/eli/reg/2006/1907/2025-09-01. 
Regulation  (EU)  2024/1735  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  on 
establishing  a  framework  of  measures  for  strengthening  Europe’s  net-zero  technology  manufacturing 
ecosystem and amending Regulation (EU) 2018/1724 (Text with EEA relevance), OJ L 1735 28.6.2024, 
p. 1. ELI: http://data.europa.eu/eli/reg/2024/1735/oj. 
Regulation  (EU)  2024/795  of  the  European  Parliament  and  of  the  Council  of  29  February  2024 
establishing  the  Strategic  Technologies  for  Europe  Platform  (STEP),  and  amending  Directive 
2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, 
(EU)  No  223/2014,  (EU)  2021/1060,  (EU)  2021/523,  (EU)  2021/695,  (EU)  2021/697  and  (EU) 
2021/241 (OJ L, 2024/795, 29.2.2024. ELI: http://data.europa.eu/eli/reg/2024/795/oj). 

EN 

32 

  EN 

 
 
recognition.  With  a  view  to  facilitate  the  implementation  and  ensure  a  consistent 
approach across the Union, the Commission could issue guidance on the application of 
those  criteria.  Recognition  of  health  biotechnology  strategic  projects  would  deliver 
clear benefits for the most innovative businesses by accelerating permitting, reducing 
administrative  burden,  improving  legal  certainty  and  facilitating  access  to  financial 
support.  It  would  thus  strengthen  their  capacity  to  scale  biotechnology  innovations 
faster. For authorities, the framework streamlines coordination, avoids duplication of 
assessments, and supports consistent, efficient decision-making. 

(13)  NAMs  applied  in    biological  research,  early  discovery,  preclinical  development,  and 
the  regulatory  and  quality  testing  of  medicinal  products  and  medical  technologies, 
have the potential to generate scientific and technological data that are comparable to, 
or  in  some  cases  more  informative  and  generated  more  rapidly  than,  those  obtained 
through  current  standard  methods.  The  resulting  advantage  will  contribute  to 
strengthen  the  innovation  ecosystem  and  enhanced  European  competitiveness  in 
biotechnology.   

(14)  Certain health biotechnology strategic projects have the potential to contribute to the 
Union’s  objectives  in  biotechnology  in  a  manner  that  is  systemic  and  can  produce  a 
multiplier  effect.  Such  projects  act  as  catalysts  for  cooperation  between  academia, 
industry  and  public  authorities,  and  can  serve  as  anchors  for  regional  biotechnology 
clusters  and  innovation  ecosystems  across  Member  States.  Experience  in  several 
Member  States  has  shown  that  such  projects  can  quickly  raise  industrial  capability, 
attract  investment  and  strengthen  the  Union’s  position  in  global  value  chains. 
Accordingly, such projects should be recognised as high impact health biotechnology 
strategic projects  by the Commission and  could be given particular consideration for 
Union funding, priority access to administrative support and fast-tracked procedures at 
Member  State  level.  As  regards  national  funding  of  such  projects,  Regulation  (EU) 
2024/7958  provides  measures  for  the  support  of  critical  and  emerging  strategic 
technologies and their respective value chains within programmes implemented under 
shared  management.  That  Regulation  amends  the  basic  acts  of  several  shared-
management  funds,  namely  Regulations  (EU)  2021/10569,  (EU)  2021/105710    and 
(EU) 2021/1058 of the European Parliament and of the Council11 , in order to enable 
Member States to steer their national and regional programmes towards investments in 
critical  technologies,  including  biotechnologies.  Without  prejudice  to  the  applicable 
rules  governing  each  such  funding  instrument,  and  in  line  with  applicable  State  aid 
rules,  this  approach  may    therefore  be  applied  to  high-impact  health  biotechnology 
strategic  projects,  which  are  deemed  in  accordance  with  this  Regulation  as  to 
contribute to the STEP objectives. 

8 

9 

10 

11 

Regulation  (EU)  2024/795  of  the  European  Parliament  and  of  the  Council  of  29  February  2024 
establishing  the  Strategic  Technologies  for  Europe  Platform  (STEP),  and  amending  Directive 
2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, 
(EU)  No  223/2014,  (EU)  2021/1060,  (EU)  2021/523,  (EU)  2021/695,  (EU)  2021/697  and  (EU) 
2021/241, ELI: . 
Regulation (EU) 2021/1056 of the European Parliament and of the Council of 24 June 2021 establishing 
the Just Transition Fund (OJ L 231, 30.6.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/1056/oj). 
Regulation (EU) 2021/1057 of the European Parliament and of the Council of 24 June 2021 establishing 
the  European  Social  Fund  Plus  (ESF+)  and  repealing  Regulation  (EU)  No  1296/2013  (OJ  L  231, 
30.6.2021, p. 21, ELI: http://data.europa.eu/eli/reg/2021/1057/oj). 
Regulation  (EU)  2021/1058  of  the  European  Parliament  and  of  the  Council  of  24  June  2021  on  the 
European  Regional  Development  Fund  and  on  the  Cohesion  Fund  (OJ  L  231,  30.6.2021,  p.  60,  ELI: 
http://data.europa.eu/eli/reg/2021/1058/oj). 

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(15)  The strategic importance of  biotechnology  for European competitiveness  has  already 
been  established,  including  through  the  proposed  a  European  Competitiveness  Fund 
(ECF)  for  the  Multiannual  Financial  Framework  (MFF)  period  2028-2034,  which 
includes  a  dedicated  ‘Health,  Biotech,  Agriculture  and  Bioeconomy’  window.  The 
Draghi  Report  on  the  Future  of  European  Competitiveness12  recommends  that  the 
Union should focus resources on a limited number of world-class centres of excellence 
in life sciences and biotechnology. High impact biotechnology health strategic projects 
have the potential to contribute to this focus of efforts and be a tool for an impactful 
use of resources in the MFF period 2028-2034, to help position the Union among the 
leading  regions  for  biotechnology.  Examples  of  categories  of  such  high  impact 
projects  and  specific  criteria  should  be  established  for  their  recognition  by  the 
Commission.  Amongst  those  categories,  high  impact  health  biotechnology  strategic 
projects  in  the  form  of  biotechnology  development  accelerators  providing,  amongst 
others, 
real-world 
biomanufacturing  processes,  should  play  a  key  role  in  translating  Europe’s  scientific 
excellence  into  productive  industrial  capacity.  By  pooling  advanced  equipment  and 
expertise  and  offering  criteria-based  access,  including  for  small  and  medium-sized 
enterprises, start-ups and scale-ups, such projects should reduce duplication of efforts, 
lower  entry  barriers,  and  foster  the  specialised  skills  required  for  advanced 
biomanufacturing. Similarly, high impact health biotechnology strategic projects in the 
form of centres of excellence for advanced therapies, including for advanced therapy 
medicinal  products,  should  combine  research,  regulatory  science  and  manufacturing 
capabilities,  enabling  faster,  safer  and  more  efficient  development  of  innovative 
therapies.  When  connected  to  digital  and  data  infrastructures,  they  should  have  the 
potential to accelerate clinical translation, improve quality control and facilitate patient 
access across the Union.  

testing  or  demonstration 

replicating 

facilities 

trusted 

(16)  To  maximise  the  Union-wide  benefits  of  investments  made  in  projects  or  entities 
operating  infrastructures,  facilities  and  services  supported  and  established  or 
recognised in accordance with this Regulation, such projects or entities should provide 
open,  non-discriminatory,  transparent  and  criteria-based  access  to  users  from  all 
Member  States,  including  academic  institutions,  industrial  undertakings,  with 
particular  attention  to  SMEs,  start-ups  and  scale-ups,  and  public  research  bodies. 
Access  conditions  should  be  proportionate  and  ensure  fair  treatment  among  users, 
taking  into  account  the  objectives  and  capacity  of  each  infrastructure,  the  need  to 
guarantee  equitable  opportunities  for  SMEs,  start-ups  and  scale-ups,  and  research 
actors,  and  appropriate  safeguards  to  protect  security,  confidentiality,  intellectual 
property and economic-security interests. 

(17)  Effective  implementation  of  objectives  pursued  in  this  Regulation  relies  on  good 
governance  and  partnership  between  all  actors  at  the  relevant  territorial  levels  and 
socio-economic  actors.  In  particular,  biotechnology  strategic  projects  aimed  at 
to  supporting  biotechnology  and 
targeting 
biomanufacturing  industries  and  to  ensuring  a  workforce  capable  to  supporting 
innovation, industrial scale-up and long-term competitiveness should be designed and 
developed  with  the  full  involvement  of  the  relevant  social  partners.  Such  active 
engagement is essential to ensure that social implications are addressed from the outset 
and to foster responsible innovation.   

talent  and  skills  shortages  vital 

12 

Draghi,  Mario.  The  future  of  European  competitiveness:  A  competitiveness  strategy  for  Europe, 
European Commission, 9 September 2024. 

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34 

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(18)  Directive (EU) 2022/2555 of the European Parliament and of the Council13 lays down 
obligations  for  essential  and  important  entities  to  ensure  a  high  common  level  of 
cybersecurity  throughout  the  Union,  including  requirements  on  risk  management, 
incident reporting and the protection of network and information systems.  Therefore, 
entities established or supported under this Regulation and falling within the scope of 
the  Directive  (EU)  2022/2555  should  comply  with  the  requirements  set  out  in  that 
Directive. 

(19) 

In order to safeguard the Union’s security, public order and strategic interests, access 
to biotechnology infrastructures and datasets of health biotechnology strategic projects 
and  of  high  impact  health  biotechnology  strategic  projects  recognised  in  accordance 
with this Regulation and that receive funding in accordance with Union programmes, 
in  relation  to  such  infrastructures  or  datasets,  should  be  governed  by  the  rules 
established in  those programmes.  This  addresses risks linked to  unlawful technology 
transfer, hostile interference or strategic dependency. 

(20)  To  provide  an  evidence  base  for  future  Union  action  to  further  strengthen  the 
biotechnology  and  biomanufacturing  sectors,  the  Commission  should  carry  out  a 
strategic  mapping  of  the  Union’s  biotechnology  ecosystem.  That  mapping  should 
analyse  industrial  capacities,  infrastructures  and  facilities  relevant  to  biotechnology 
research,  development,  testing  and  manufacturing,  and  assess  factors  affecting  the 
Union’s ability to attract and retain investment in biomanufacturing, including  access 
to public and private risk-tolerant capital across all stages of the innovation cycle, the 
development  and  coordination  of  biotechnology  clusters  and  biomanufacturing 
ecosystems  across  the  Union,    and  assess  challenges  and  needs  in  terms  of  the 
workforce. 

(21)  Recognising  the transformative role of data and  AI in  the  area of biotechnology  and 
biomanufacturing, that mapping should also assess access to data, computing capacity 
and digital infrastructure for the health biotechnology sector and identify measures to 
foster  responsible  AI-enabled  biotechnology  innovation  and  possible  measures  to 
mitigate  related  risks,  building  on  analyses  done  in  the  context  of  existing  Union 
initiatives  such  as  the  European  Health  Data  Space14  ,  the  Apply  AI  Strategy15,  the 
Data Union Strategy16, the AI Continent Action Plan17 and the European Strategy for 
AI  in  Science18.  With  a  view  to  ensuring  appropriate  cooperation  with  the  Member 
States and optimising the use of relevant knowledge and expertise available at Union 

13 

14 

15 

16 

17 
18 

Directive  (EU)  2022/2555  of  the  European  Parliament  and  of  the  Council  of  14  December  2022  on 
measures  for  a  high  common  level  of  cybersecurity  across  the  Union,  amending  Regulation  (EU)  No 
910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive), OJ 
L 333, 27.12.2022, pp. 80. ELI: http://data.europa.eu/eli/dir/2022/2555/oj. 
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the 
European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ 
L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj). 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions: Apply AI Strategy, COM(2025)723 
final of 8 October 2025. 
Communication  from  the  Commission  to  the  European  Parliament  and  the  Council,  Data  Union 
Strategy, Unlocking Data For AI, COM(2025) 835 final, 19 November 2025. 
https://ec.europa.eu/newsroom/dae/redirection/document/114523  
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the  Committee of the Regions:  European Strategy for Artificial 
Intelligence  in  Science  –  Harnessing  AI  for  research,  innovation  and  excellence  in  the  Union, 
COM(2025)724 final of, 8 October 2025. 

EN 

35 

  EN 

 
 
level,  such  mapping  should  be  conducted  by  the  Commission  in  cooperation  with 
relevant  Union  agencies  and  bodies,  including,  where  relevant,  the  AI  Board 
established  under  the  Regulation  (EU)  2024/1689,    and  with  the  European  Health 
Biotechnology  Steering Group (‘the Steering Group’) established in  accordance  with 
this Regulation, to facilitate its implementation, provide advice to the Commission and 
to the Member States, and ensure coordinated action in particular with regard to health 
biotechnology  strategic  projects  and  high  impact  health  biotechnology  strategic 
projects.  

In order to ensure a transparent, coherent and efficient process for the identification of 
health  biotechnology  strategic  projects,  each  Member  State  should  designate  a 
competent  authority  responsible  for  assessing  and  verifying  whether  a  project  fulfils 
the conditions set out in this Regulation for its recognition as a health biotechnology 
strategic project. The designated authority should carry out the assessment through a 
fair,  transparent  and  time-bound  process.  Where  a  project  is  found  to  fulfil  the 
conditions  for  recognition  as  a  biotechnology  strategic  project,  the  designated 
authority should issue a formal recognition decision. 

(22) 

(23)  Considering their systemic and cross-border relevance and the benefits associated with 
their  status  as  high  impact  health  biotechnology  strategic  project,  the  recognition  of 
such  projects  should  take  place  through  a  two-tier  process,  involving  authorities 
designated  by  the  Member  States  for  that  purpose  and  the  Commission.  Such 
authorities  should  assess  and  transmit  the  applications  and  their  assessment  to  the 
Commission in view of the adoption of a Commission decision. This two-tier process 
should  ensure  that  such projects  are  subject  to  an  additional  Union-level  verification 
and  benefit  from  consistent  recognition  standards  across  the  Union.  With  a  view  to 
ensure peer review, cooperation with the Member States and coherent implementation 
across the Union, in adopting its decision the Commission should take into account the 
views  of  the  European  Health  Biotechnology  Steering  Group  established  by  this 
Regulation.  

(24)  With a view to enabling the efficient alignment between the Union funding procedures 
and  the  objectives  of  this  Regulation  regarding  the  support  to  high  impact  strategic 
health  biotechnology  projects,  and  to  ensure  that  projects  with  the  highest  Union 
added value can rapidly benefit from priority support, in addition to the recognition of 
such  projects  through  a  Commission  decision,  the  Commission  could  have  the 
possibility  to  recognise  such  projects  also  in  the  context  of  calls  for  proposals 
launched under the relevant Union funding programmes.  

(25)  To achieve critical mass and ensure that strategic investments deliver wider benefits, 
creating  positive  spill-over  effects  that  reinforce  the  Union’s  competitiveness, 
networking  and  cooperation  among  health  biotechnology  strategic  projects,  high 
impact  health  biotechnology  strategic  projects,  research  organisations,  industrial 
clusters and other relevant actors across borders, should be promoted and facilitated by 
the  Commission  and  the  Member  States,  with  a  view  to  help  pooling  national  and 
interoperable 
Union 
infrastructures  and  digital  platforms  and  facilitate  knowledge 
transfer.  This 
cooperation should be in compliance with Union competition law. 

the  development  of 

facilities,  promote 

resources  and 

(26)  Such  networking  and  cooperation  should  integrate,  collaborate  with,  or  build  upon, 
existing  networks  emerging  from  other  Union  initiatives  relevant  for  biotechnology, 
including  those  operating  under  the  European  Cluster  Collaboration  Platform,  the 
European  Cluster  Alliance,  networks  supported  under  Horizon  Europe,  the  Smart 

EN 

36 

  EN 

 
(27) 

Specialisation  Partnerships,  and  the  European  Network  of  Centres  of  Excellence  for 
Advanced  Therapy  Medicinal  Products  (ATMPs)  announced  by  the  Commission  in 
the  European  Strategy  for  Life  Sciences19,  the  European  Reference  Networks  as 
defined in Directive 2011/24/EU of the European Parliament and of the Council20 and 
the  EU  Network  of  Comprehensive  Cancer  Centres  announced  by  Europe’s  Beating 
Cancer Plan21. Such cooperation should aim to reinforce synergies, facilitate access to 
regional  and  Union  level  funding,  and  enhance  the  coordination  of  biotechnology-
related innovation ecosystems across the Union. 

In order to reduce complexity and increase efficiency, transparency and consistency in 
the permit-granting process for health biotechnology strategic projects and high impact 
health  biotechnology  strategic  projects,  there  should  be  a  single  point  of  contact  at 
national  level  that  is  responsible  for  facilitating  and  coordinating  the  entire  permit-
granting  process.  The  single  point  of  contact  should  be  the  interface  between  the 
promoters  of  health  biotechnology  strategic  projects  or  of  high  impact  health 
biotechnology  strategic  projects  and  the  relevant  permitting  authorities.  To  that  end, 
Member States should establish or designate one or more authorities as single points 
of  contact.  With  a  view  to  ensure  streamlined  processes,  that  single  point  of  contact 
should  be  the  same  as  the  single  point  of  contact  referred  to  in  Regulation  (EU)  ../.. 
[Regulation  on  speeding-up  environmental 
impact  assessmentsc  -  permitting 
the 
regulation],  responsible  for  facilitating  and  coordinating  all  aspects  of 
environmental assessments. It should be for Member States to decide whether a single 
point  of  contact  is  also  an  authority  that  makes  permitting  decisions.  To  ensure  the 
effective implementation of their responsibilities, Member States should provide their 
single  points  of  contact,  as  well  as  any  authority  involved  in  the  permit-granting 
process with sufficient personnel and resources. 

(28)  The  Union  has  progressively  recognised  health  biotechnology  as  a  strategic  sector 
contributing  to  Union’s  overall  resilience.  Regulation  (EU)  2024/795  identifies 
biotechnology  among  the  strategic  technologies  essential  for  reducing  the  Union’s 
strategic  dependencies  and  strengthening  its  economic  and  industrial  resilience.  The 
Commission  Communication  Commission  Communication  ‘Building  the  future  with 
nature:  Boosting  Biotechnology  and  Biomanufacturing  in  the  EU’  further  identifies 
biotechnology  and  biomanufacturing  as  strategic 
for  Europe’s 
competitiveness,  resilience  and  autonomy,  and  furthermore  explicitly  recognises  that 
health  biotechnology  is  essential  for  health-system  resilience.  In  view  of  this 
consistent  Union  framework  confirming  biotechnology’s  systemic  contribution  to 
resilience,  health  biotechnology  strategic  projects  and  high 
impact  health 
biotechnology  strategic  projects  should  therefore  be  deemed  to  contribute  to  the 
objectives  referred  to  in  Article  14  of  Regulation  […]  [Regulation  on  speeding-up 
environmental assessments – permitting regulation]. 

technologies 

19 

20 

21 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  A  strategy  for  European  life 
sciences: Choose Europe for life sciences – A strategy to position the EU as the world’s most attractive 
place for life sciences by 2030, COM(2025) 525 final of 2 July 2025. 
Directive  2011/24/EU  of  the  European  Parliament  and  of  the  Council  of  9  March  2011  on  the 
application  of  patients’  rights 
in  cross-border  healthcare,  OJ  L  88,  4.4.2011,  pp.  45–65. 
ELI: http://data.europa.eu/eli/dir/2011/24/oj. 
Communication from the Commission to the European Parliament and the Council, Europe's Beating 
Cancer Plan, COM/2021/44 final of 3 February 2021. 

EN 

37 

  EN 

 
 
(29) 

(30) 

In  light  of  their  contribution  to  the  Union’s  competitiveness,  resilience  and 
preparedness, health biotechnology strategic projects recognised by the Member States 
in  accordance  with  this  Regulation  should be  considered to  be in the public interest. 
Similarly, Member States should grant such projects the highest national significance 
available  under  their  national  law,  meaning  the  strongest  designation  applicable  to 
major  strategic  projects,  and  should  apply  the  corresponding  procedural  advantages, 
including  priority  treatment  and  coordinated  and  accelerated  permit-granting,  and 
adopt facilitation measures in compliance with Union law.  

In view of the potential for cross-border and systemic benefits of high impact  health 
biotechnology  strategic  projects,  on  the  basis  of  its  case-by-case  assessment,  a 
permitting  authority  can  conclude  that  the  public  interest  served  by  the  project 
overrides the  public interests related to  nature  and environmental protection and that 
consequently  the  project  can  be  authorised,  provided  that  all  relevant  conditions  set 
out  in  Directives  2000/60/EC22,  2009/147/EC23  or  92/43/EEC24  of  the  European 
Parliament and of the Council, or in  Union legislative acts  on nature  restoration, are 
met. 

(31)  To  ensure  predictability  and  administrative  efficiency,  the  overall  duration  of  the 
permit-granting process should be limited to ten months from the acknowledgement of 
a  complete  application,  for  biotechnology  health  strategic  projects,  and  to  eight 
months,  for  high  impact  health  biotechnology  strategic  projects,  given  the  need  to 
prioritise  the  speed  of  their  implementation  over  any  other  type  of  biotechnology 
project.  In  exceptional  and  duly  justified  circumstances  an  extension  of  up  to  three 
months should be permitted. 

(32)  Member  States  whose  territories  are  concerned  by  health  biotechnology  strategic 
projects  or  high  impact  health  biotechnology  strategic  projects  should  take  all 
appropriate  measures  to  facilitate  their  timely  and  effective  development  and 
deployment.  Such  measures  should  include  the  provision  of  administrative  support, 
upon  the  request  of  project  promoters,  as  well  as,  without  prejudice  to  Union 
competition law, of public financial and technical support, with a particular attention 
paid to SMEs, start-ups and scale-ups. 

(33)  The  Commission  should  complement  the  action  of  the  Member  States  in  support  of 
health  biotechnology  strategic  projects,  closely  cooperating  with  them,  including 
through  the  European  Health  Biotechnology  Steering  Group  established  by  this 
Regulation,  to  ensure  synergy  and  optimal  outcomes.  In  particular,  the  Commission 
should assist project promoters in identifying relevant funding opportunities available 
under existing Union funding programmes, including through actions of the EU Health 
Biotechnology  Support  Network  established  in  this  Regulation  with  the  purpose  of 
assisting  biotechnology  actors 
in  navigating  regulatory  health  biotechnology 
procedural pathways and identifying funding, scaling up and networking opportunities 
across  the  Union.  Further,  to  strengthen  the  Union’s  biotechnology  innovation 
ecosystem,  the  Commission  should  also  promote  measures  that  enhance  access  of 

22 

23 

24 

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a 
framework  for  Community  action  in  the  field  of  water  policy,  OJ  L  327,  22.12.2000,  p.  1.  ELI: 
http://data.europa.eu/eli/dir/2000/60/oj. 
Directive  2009/147/EC  of  the  European  Parliament  and  of  the  Council  of  30  November  2009  on  the 
conservation of wild birds, OJ L 20, 26.1.2010, pp. 7-25. ELI: http://data.europa.eu/eli/dir/2009/147/oj. 
Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna 
and flora, OJ L 206, 22.7.1992, p. 7. ELI: http://data.europa.eu/eli/dir/1992/43/oj 

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small  and  medium-sized  enterprises,  start-ups  and  scale-ups  to  research  and 
technological infrastructures, including those funded through Union programmes. 

(34)  High  impact  health  biotechnology  strategic  projects  should  benefit  from  financial, 
technical  and  administrative  support  measures.  In  addition,  in  order  to  ensure  that 
Union  resources  for  biotechnology  are  channelled  towards  the  actions  that  have  the 
potential to deliver the most benefits at Union level, high impact health biotechnology 
strategic projects  could be given particular consideration for financial support, in the 
context of the preparation, adoption and implementation by the Commission of work 
programmes for the relevant Union programmes, funds and instruments.  

(35)  The  scale  and  nature  of  the  Union  support  for  high  impact  health  biotechnology 
strategic  projects  might  require  long-term  coordination  and  large-scale  public  and 
private  investment.  In  this  context,  public-private  partnerships  play  a  key  role  in 
pooling  expertise,  sharing  risks  and  accelerating 
innovation. 
Consequently,  the  Commission  could  envisage  to  propose  in  the  future  the 
establishment of appropriate legal entities to mobilise investments, coordinate research 
and  innovation  activities  and  support  for  the  industrial  deployment  of  biotechnology 
and  biomanufacturing  capacities  across  Member  States,  while  ensuring  close 
alignment with Union policy objectives. Those legal arrangements could take the form 
of  European  Partnerships  where  the  Union  together  with  private  and/or  public 
partners,  acting  in  full  compliance  with  competition  rules,  commit  to  jointly 
supporting  the  development  and  implementation  of  a  programme  of  activities, 
including those related to market, regulatory or policy uptake. 

the  uptake  of 

(36)  With a view to ensuring that the most favourable provisions apply cross-frameworks, 
the  provisions  of  this  Regulation  regarding  the  permit  granting  process,  the  priority 
status  of  health  biotechnology  strategic  projects  and  of  high  impact  health 
biotechnology strategic projects and the administrative, technical or financial support 
for  such  projects  should  apply  without  prejudice  to  more  favourable  provisions  laid 
down in other Union legislation. 

(37)  Biotechnology undertakings, especially SMEs, start-ups and scale-ups, and non-profits 
face  challenges  in  navigating  the  regulatory  processes,  financing,  scaling  up  and 
networking opportunities in the Union. To address those challenges, the Commission 
should  manage,  coordinate  and  support  an  EU  Health  Biotechnology  Support 
Network, composed of national and regional antennas, leveraging and complementing 
existing  structures  such  as  the  European  Enterprise  Network.  The  Network  should 
assist developers and project promoters, in particular SMEs, start-ups, and scale-ups, 
in  navigating  more  efficiently  the  legislative  framework,  health  biotechnologies 
regulatory pathways and funding opportunities at Union and national level. Moreover, 
the  EU  Health  Biotechnology  Support  Network  should  provide  support  for  health 
biotechnology  strategic  projects  and  enhanced  assistance  for  high  impact  health 
biotechnology  strategic  projects.  The  Commission  should  make  available  to  the 
Network an AI powered interactive tool to assist developers and project promoters, in 
particular SMEs, start-ups, and scale-ups, in navigating more efficiently the regulatory 
framework and pathways and funding opportunities at EU and national level.  

(38)  The European Health Biotechnology Steering Group (‘the Steering Group’) should be 
established to provide advice to the Commission and to the Member States with a view 
to  facilitate  the  implementation  of  this  Regulation,  foster  cooperation  with  the 
Commission  and  among  the  Member  States,  and  the  exchange  of  best  practice.  The 

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Steering Group should be composed of representatives from all Member States and the 
Commission.  

(39)  Member States should provide to the Steering Group, on an annual basis, an overview 
of  the  health  biotechnology  strategic  projects  and  of  the  high  impact  health 
biotechnology  strategic  projects  that  they  recognise,  as  well  as  of  the  existing  and 
emerging cooperation initiatives and networks among such projects. Such overview is 
aimed at  informing  monitoring of progress  in  the implementation  of this Regulation, 
supporting  coordination  and  proposals  of  measures  to  enhance  the  Union’s 
biotechnology  and  biomanufacturing  ecosystem  and  facilitate  exchange  of  best 
practices.  In  such  overview,  Member  States  should  identify  progress,  obstacles  and 
best practices.  

(40)  To  ensure  effective  governance  and  learning  across  the  Union,  the  Steering  Group 
should  periodically  review  systemic  challenges  in  the  financing  and  deployment  in 
particular  for  high  impact  health  biotechnology  strategic  projects  and  recommend 
corrective measures to the Commission and to Member States. 

(41)  Given  the  capital-intensive  nature  of  biotechnology  and  the  high  probability  of  non-
commercialisation  of  individual  projects,  access  to  finance  is  a  structural  bottleneck 
for  the  sector.  To  boost  the  potential  of  biotechnology  to  contribute  to  the  Union’s 
competitiveness, resilience and the creation and maintenance of quality jobs, sufficient 
funding tailored to the sector’s risk profile needs to be mobilised across the financing 
life cycle.  

(42)  To  address  key  challenges  in  the  functioning  of  Union  capital  markets,  the 
Commission is implementing the Savings and Investment Union (SIU)  Strategy. The 
SIU  will  reduce  market  fragmentation,  create  better  investment  opportunities  for 
citizens and help to expand funding options for businesses. In particular, it will seek to 
improve access to equity and debt financing for all companies, including startups and 
scaleups,  strengthen  the  role  of  venture  capital  and  institutional  investors  and  better 
align  Union  public  funding  instruments  with  SIU  objectives.  Recent  Commission 
guidance on legislative programmes25 also clarifies that the biotechnology  sector can 
be the target of Union, national and regional legislative programmes via reference to 
the  Competitiveness  Compass,  supporting  favourable  prudential 
treatment  of 
investments made under such programmes.  

(43)  The  Union’s  biotechnology  sector  faces  a  persistent  financing  gap  compared  with 
other  leading  regions,  particularly  for  the  scale-up  and  industrial  deployment  stages. 
The  Union  has  been  acting  to  address  this,  including  through  the  flagship  InvestEU 
programme established by Regulation (EU) 2021/523 of the European Parliament and 
of  the  Council26.  InvestEU  supports  biotechnology  investments  in  a  transversal 
manner,  enabling  investment  in  biotechnology  projects  and  enterprises  targeting  all 
stages  of  development,  including  start-up  to  scale-up  stages  as  well  as  deployment. 
The recent agreement between the Council and the European Parliament on enhancing 
the InvestEU programme increases the Union guarantee by EUR 2.9 billion unlocking 
nearly  EUR  55  billion  in  additional  public  and  private  investments,  including 
investment  into  biotechnology.  Overall,  InvestEU  has  already  mobilized  EUR  7.5 

25 
26 

C(2025) 7231 final 
Regulation  (EU)  2021/523  of  the  European  Parliament  and  of  the  Council  of  24  March  2021 
establishing the InvestEU Programme and amending Regulation (EU) 2015/1017, OJ L 107, 26.3.2021, 
pp. 30–89. ELI: http://data.europa.eu/eli/reg/2021/523/oj. 

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billion of biotechnology investments. During the 2026-2027 period, mobilization of at 
least  EUR  4  billion  of  additional  biotechnology  investments  is  expected.  InvestEU 
implementing  partners  play  a  key  role  in  helping  to  stimulate  investment  in 
biotechnology  projects  and  enterprises.  Both  the  EIB  as  well  as  EIF  support 
biotechnology  –  including  health  biotechnology  –  via  several  InvestEU  financial 
products.  HERA  Invest  further  boosts  investments  in  health  biotechnology.  The 
project pipeline is strengthened through InvestEU advisory, supporting initiatives such 
as the European Tech Championship Initiative of the European Investment Bank. 

(44) 

 Complementing  the  European  Innovation  Council  support  for  deep  tech  and 
disruptive  innovators  in  the  area  of  biotechnology,  an  EU  Health  Biotechnology 
Investment Pilot to mobilise public and private investment and strengthen the Union’s 
competitiveness  and  resilience  should  be  created  in  partnership  with  the  European 
Investment Bank Group (EIBG) or other implementing partners, for implementation in 
indirect  management,  linking  equity  and  guarantee  instruments  with  venture  debt 
tailored to biotech-specific risk profiles.  

(45)  The  Health  Biotechnology  Investment  Pilot  would  aim  to  mobilise  a  substantial 
amount of capital, from the EIBG, Union budget, public national schemes and private 
sector  investors  (including  institutional  investors),  to  narrow  the  sector  investment 
gap, currently estimated at EUR 40 billion annually, amounting to EUR 400 billion for 
the  next  10  years,  and  ensure  the  sector's  long  term  competitiveness  and  strategic 
autonomy. 

(46)  The  Health  Biotechnology  Investment  Pilot  should  be  tailored  to  biotechnology  risk 
profiles  and  lifecycle  needs  on  the  Union  market.  It  should  be  possible  to  include 
newly created and established instruments, encompassing advisory services, direct and 
indirect individual investments, direct and indirect intermediated financing or portfolio 
financing.  The  detailed  instruments,  eligibility  and  risk  parameters,  and  indicative 
allocations should be specified in the operational design of the Pilot. 

(47)  The  Pilot  may  receive  Union  financial  support  through  Union  programmes.  Pending  
the establishment of the Pilot, a scheme, also covering ongoing investment activities, 
launched  with  the  support  of  the  EIBG  under  the  current  Multiannual  Financial 
Framework  2021-2027  and  supported  under  the  InvestEU  programme,  will  mobilise 
up to 10 billion in investments in the biotechnology sector in 2026 and 2027 . 

(48)  Union public equity markets for biotechnology remain shallow relative to global peers, 
which  constrains  late-stage  financing  and  exit  options  for  European  start-ups  and 
scale-ups.  Stock  exchanges  are  still  largely  fragmented  across  Member  States,  with 
limited  specialised  research  coverage  and  dedicated  market-making,  prompting 
European scale-ups to list abroad. To address this bottleneck for a competitive Union 
biotechnology  sector  and  complement  the  SIU  strategy,  which  seeks  to  promote 
integration and increase the depth of Union capital markets, projects contributing to a 
Union  late-stage  capital  booster  pilot  should  be  recognised  by  the  Commission  as 
high-impact health biotechnology strategic projects in accordance with the conditions 
laid down in this Regulation.  

(49)  Biotechnology  is  central  for  the  Union’s  sovereignty,  strategic  autonomy  and 
innovation  leadership.  In  this  regard,  the  Union  is  taking  action  to  pursue  its  policy 
objectives  in  biotechnology,  including  through  the  Framework  Programme  for 
Research  and  Innovation  established  by  Regulation  (EU)  2021/695  of  the  European 

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Parliament  and  of  the  Council27  which  is  supporting  the  implementation  of  the  Life 
Sciences Strategy, and other relevant ‘Choose Europe’ initiatives.  

(50)  The  Commission  has  proposed  a  European  Competitiveness  Fund  (ECF)28  for  the 
MFF  period  2028-2034,  aiming  to  increase  European  competitiveness,  notably  in 
strategic  sectors  and  technologies  along  the  investment  journey.  It  is  proposed  to  be 
structured  along  four  policy  windows  reflecting  strategic  priorities  crucial  to  Union 
competitiveness  and  resilience.  It  proposes  funding  to  support  the  biotechnology 
sector through a ‘Health, Biotech, Agriculture and Bioeconomy’ window. 

(51)  Companies, projects and initiatives falling within the scope of this Regulation could be 
given  particular  consideration  for  financial  support  from  Union  led  initiatives, 
including  those  that  aim  to  leverage  private  capital,  and  from  Union  funding 
programmes  and  instruments,  as  projects  in  a  strategic  technology  and,  where 
appropriate,  in  a  strategic  deep  tech  area.  Such  initiatives,  programmes  and 
instruments  include  the  cohesion  policy  programmes,  the  InvestEU  programme,  the 
EIBG’s TechEU programme and the European Tech Champions Initiative, supported 
by  InvestEU,  and  launched  by  the  EIBG  with  several  Member  States,  and  the 
European  Innovation  Council  established  under  the  Horizon  Europe  Programme,  as 
well instruments for the duration of the MFF 2028-2034. 

(52)  Further,  high-impact  health  biotechnology  strategic  projects  are  projects  with  a  high 
European  added  value,  including  cross-border  projects,  expected  to  bring  structural 
economic  transformation,  productivity,  long-term  growth  and  quality  jobs  in  the 
biotechnology  sector,  and benefiting the  Single  Market. Considering the necessity  to 
align Union, public and private spending with Union competitiveness priorities29, such 
projects could be given particular consideration for Union financial support including 
in  the  form  of  blended  financing,  under  Union  programmes,  funds  and  financial 
instruments.  

(53)  Regulation (EU) 2024/795 establishes that the development and manufacturing in the 
Union of biotechnologies, together with digital technologies and deep tech innovation, 
clean and resource-efficient technologies are essential for the purpose of reducing the 
Union’s strategic dependencies, and for the green and digital transitions, thus ensuring 
the  sovereignty  and  strategic  autonomy  of 
the 
competitiveness  and  sustainability  of  the  Union’s  industry.  Accordingly,  that 
Regulation establishes a Strategic Technologies for Europe Platform (STEP) to better 
channel and mobilise resources within the existing Union programmes towards critical 
investment,  including  in  Union-wide  and  cross-border  projects,  that  have  the  aim  of 
supporting  the  development  or  manufacturing  of  critical  and  emerging  technologies 
and their respective value chains, in strategic sectors, including in biotechnology.  

the  Union  and  promoting 

27 

28 

29 

Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing 
Horizon  Europe  –  the  Framework  Programme  for  Research  and  Innovation,  laying down  its  rules  for 
participation  and  dissemination,  and  repealing  Regulations  (EU)  No  1290/2013  and  (EU)  No 
1291/2013, OJ L 170, 12.5.2021, pp. 1. ELI: http://data.europa.eu/eli/reg/2021/695/oj. 
As  per  Proposal  for  a  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE 
COUNCIL  on  establishing  the  European  Competitiveness  Fund  ('ECF’),  including  the  specific 
programme for defence research and innovation activities, repealing Regulations (EU) 2021/522, (EU) 
2021/694,  (EU)  2021/697,  (EU)  2021/783,  repealing  provisions  of  Regulations  (EU)  2021/696,  (EU) 
2023/588, and amending Regulation (EU) [EDIP]. 
Commission  Staff  Working  Document,  Impact  Assessment  Report  on  the  European  Competitiveness 
Fund, SWD(2025) 555 final.  

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(54)  Union-level  funding  may  be 

leveraged 

investments 

to  facilitate 

in  health 
biotechnology  strategic  projects  and  high  impact  health  biotechnology  strategic 
projects  recognised  in  accordance  with  this  Regulation.  Such  projects  may  benefit 
from  access  to  existing  Union  funding  instruments,  where  they  fulfil  the  criteria 
established  in  those  instruments.  Authorities  in  charge  of  the  Union  programmes 
covered  by  Regulation  (EU)  2024/795  should  consider  supporting  biotechnology 
health  strategic  projects  and  high  impact  health  biotechnology  strategic  projects 
recognised in accordance with this Regulation. Therefore, Regulation (EU) 2024/795 
should  be  amended  to  provide  that  health  biotechnology  strategic  projects  and  high-
impact  health  biotechnology  strategic  projects  recognised  in  accordance  with  this 
Regulation  should be deemed to  contribute to  the STEP  objectives  of supporting  the 
development  or  manufacturing  of  critical  technologies  in  biotechnologies  throughout 
the Union, or safeguarding and strengthening their respective value chains and also in 
addressing shortages of labour and skills critical to all kinds of quality jobs in support 
of that objective, as appropriate. 

(55)  Member  States  may  provide  financial  support  to  biotechnology  as  a  strategic 
technology for the Union’s innovation capacity, sovereignty, resilience and leadership, 
including  in  the  implementation  of  the  relevant  Union  programmes.  In  this  regard, 
Member States should act in compliance with Union competition law and make use as 
appropriate  of  the  relevant  frameworks.  This  includes  the  criteria  for  the  analysis  of 
the  compatibility  with  the  internal  market  of  State  aid  to  promote  the  execution  of 
important projects of common European interest30 (IPCEIs), the guidance on the basis 
of a compatibility assessment conducted by the Commission regarding aid to promote 
research,  development  and  innovation31,  the  Commission  Regulation  (EU)  No 
651/201432 and the Clean Industrial Deal State Aid Framework33. 

(56)  Strategic projects in health biotechnology may require blended financing from private, 
national and Union sources. National funding should be in full compliance with State 
Aid  rules.  The  Commission,  including  through  the  European  Biotechnology  Support 
Network,  should  support  project  promoters  in  liaising  with  potential  investors. 
Similarly,  the  European  Health  Biotechnology  Steering  Group  established  by  this 
Regulation should coordinate financing for biotechnology health strategic projects and 
high-impact health biotechnology strategic projects. 

(57)  Medicinal products developed with innovative biotechnology technologies which will 
bring a therapeutic advantage to patients should be incentivised with an extension of 
the Supplementary Protection Certificate.  

(58)  The significant advances in analytical methodologies and biocompatibility assessment 
tools  enable  more  precise  demonstration  of  comparability  between  biosimilar 
medicines  (‘biosimilars’)  and  their  reference  biological  medicinal  products.  Building 

30 

31 

32 

33 

Communication  from  the  Commission  Criteria  for  the  analysis  of  the  compatibility  with  the  internal 
market of State aid to promote the execution of important projects of common European interest 2021/C 
528/02, C/2021/8481, OJ C 528, 30.12.2021, pp. 10.  
Communication  from  the  Commission  Framework  for  State  aid  for  research  and  development  and 
innovation 2022/C 414/01, C/2022/7388, OJ C 414, 28.10.2022, pp. 1.  
Commission  Regulation  (EU)  No  651/2014  of  17  June  2014  declaring  certain  categories  of  aid 
compatible with the internal market in application of Articles 107 and 108 of the Treaty Text with EEA 
relevance, OJ L 187, 26.6.2014, pp. 1. ELI: http://data.europa.eu/eli/reg/2014/651/2023-07-01. 
COMMUNICATION FROM THE COMMISSION – Framework for State Aid measures to support the 
Clean Industrial Deal (Clean Industrial Deal State Aid Framework), C/2025/7600, OJ C, C/2025/3602, 
4.7.2025. 

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on its ongoing work on a Reflection paper on a tailored clinical approach in biosimilar 
development34, the European Medicines Agency35 (‘the Agency’) should develop non-
binding  guidance  giving  consideration  to  a  potential  reduction  of  the  clinical  data 
required for the development and marketing authorisation procedures for biosimilars, 
based on robust analytical and other non-clinical evidence. 

(59)  The  manufacturing  capacity  and  expertise  for  biosimilars  in  the  Union  can  greatly 
contribute  to  ensure  Union  competitiveness,  strategic  autonomy  and  resilience,  both 
from  a  health  and  sustainability  perspective.  Therefore,  Member  States  should 
recognise, and support projects that fulfil the conditions laid down in this Regulation 
for strategic projects for biosimilars manufacturing.  

(60)  Biosimilars can play an important role in diversifying and strengthening supply chains, 
promoting competition and fostering economic growth in the Union and for its global 
partners.  Accordingly,  the  promoters  of  strategic  projects  for  biosimilars  and  the 
companies  active  in  this  area  should  be  encouraged  to  establish  or  strengthen 
cooperation with international biotechnology clusters.  

(61)  AI can enhance the development, safety, efficiency and scale-up of biotechnology and 
biomanufacturing,  provided  that  its  use  is  responsible  and  aligned  with  Union 
legislation. To pursue this, the Commission and the Member States should promote an 
AI-first  policy  approach  as  introduced  in  the  Apply  AI  Strategy  when  implementing 
this Regulation and the exchange of knowledge, standards and best practices relevant 
to the responsible application of the AI-First Policy Approach36. The responsible and 
effective  integration  of  AI  can  enhance  research,  development  and  regulatory 
processes  and 
in 
biotechnology.  The  Commission  and  the  Member  States  should  therefore  encourage 
the uptake of such approaches and facilitate the exchange of knowledge, standards and 
best  practices  relevant  to  their  application.  That  cooperation  should  remain  fully 
compliant with Union competition rules. 

the  competitiveness  of  Union 

thereby  support 

innovators 

(62)  The  rapid  expansion  and  increasing  complexity  of  AI  applications  throughout  the 
medicinal-product  lifecycle requires structured  and coherent  guidance to  ensure their 
safe,  effective  and  trustworthy  use.  The  Agency  is  developing  expertise  in  this  area 
through  initiatives  such  as  the  Good  Manufacturing  Practice  (GMP)  Annex  22  – 
Artificial  Intelligence,  Q&A  in  AI  in  Pharmacovigilance,  the  GCP  Annex  to  the 
Guideline  on  computerised  systems  and  electronic  data  in  clinical  trials  and  AI  in 
Clinical  Development.  It  is  therefore  appropriate  for  the  Agency  to  develop  non-
binding  guidance  on  the  deployment  and  use  of  systems  based  on  advanced 
technologies,  including  of  AI  systems  and  of  general-purpose  AI  models  across 
development,  manufacturing,  clinical  trials,  and  post-authorisation  activities  for 
compliance with applicable Union legislation in the health area. To ensure consistency 

34 

35 

36 

at: 

EMA Reflection paper on a tailored clinical approach in biosimilar development, 17 March 2025, draft 
accessible 
https://www.ema.europa.eu/en/documents/other/reflection-paper-tailored-clinical-
approach-biosimilar-development_en.pdf 
[Revised  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL  laying 
down Union procedures for the authorisation and supervision of medicinal products for human use and 
establishing  rules  governing  the  European  Medicines  Agency,  amending  Regulation  (EC)  No 
1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation 
(EC) No 141/2000 and Regulation (EC) No 1901/2006] 
Communication from the Commission to the European Parliament and the Council,  Apply AI Strategy, 
COM/2025/723 final.  

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across the health and digital domains, when developing or updating such guidance, the 
Agency  should  cooperate  with  the  Commission,  including  the  AI  office  and  should 
consult  relevant  national  competent  authorities  and  stakeholders,  and  relevant  expert 
coordination groups established under Union legislation in the health and digital areas, 
as appropriate. 

(63)  Moreover,  the  Agency  should  develop  non-binding  guidance  on  the  deployment  and 
use  of  AI  systems  and  of  general-purpose  AI  models  also  in  the  procedures  for  the 
authorisation  of  medicinal  products,  with  a  view  to  optimising  processes  and 
increasing efficiency of regulatory activities. Such guidance should be developed and 
published  in  agreement  with  the  Commission,  the  AI  Board  and  the  competent 
authorities. 

(64) 

the  Union 

requires  dedicated 

In order to accelerate the development and scale-up of biotechnology innovations that 
are  enabled,  enhanced  or  significantly  supported  by  AI  and  advanced  computational 
methods, 
that  combine 
experimental, computational and data-driven capabilities. Given their essential role for 
supporting  AI-enabled  biotechnology  innovations,  it  is  appropriate  to  establish 
requirements in this Regulation for the recognition by the Commission and the support 
for  high-impact  health  biotechnology  strategic  projects  in  the  form  of  biotechnology 
testing environments, under certain conditions. 

testing  environments 

(65)  Such environments could provide the wet-lab, bioprocess, pilot-line and translational 
validation capacities necessary for AI-enabled biotechnology development, and should 
complement,  without  duplicating,  the  functions  of  regulatory  sandboxes  established 
under  Union  or  national  law  as  well  as  the  testing  and  experimentation  facilities 
established  in  accordance  with  Regulation  (EU)  2024/1689.  Where  relevant,  they 
should  also  leverage  health  data  and  the  European  Health  Data  Space  in  accordance 
with  Union  legislation.  These  infrastructures  should  support  the  development  of 
biotechnology  applications  where  the  use  of  AI  has  the  potential  to  accelerate 
progress, in particular in health-related areas such as advanced therapies, where AI can 
improve  efficacy  and  safety  —  for  example  through  optimised  CRISPR  site 
prediction,  tumour  antigen  identification,  sequence  engineering,  delivery-vehicle 
design, or the matching of diverse patient cancer-cell variants with CAR-T cell types. 

(66)  Having high-quality, interoperable, provenance-verified and well-annotated datasets is 
essential for the development, testing and validation of trustworthy and competitive AI 
systems  and  models  used  in  biotechnology  applications.  For  example,  datasets 
generated in the course of provision of healthcare are usually recorded in a way that 
supports  their  initial  purpose,  such  as  diagnosis  or  treatment.  Often,  they  are 
technically not easily usable and fit for training, testing and validation of AI systems, 
for example due to the use of different data standards or lacking annotations. Given the 
potential  of  AI  systems  and  models  to  support  research  and  innovation  in 
biotechnology  applications,  it  is  important  to  ensure  that  high-quality  data  are 
available  for  training,  testing  and  validating  AI  systems  and  models  used  in  health 
biotechnology applications. To make such data more easily usable for those purposes, 
it is appropriate to facilitate the enhancement of the quality of that data. Therefore, this 
Regulation should lay down provisions for the recognition by the Commission of high 
impact  health  biotechnology  strategic  projects  in  the  form  of  biotechnology  data 
quality accelerators, to provide assistance to entities that lawfully hold relevant data to 
improve data quality, standardize such data and make further improvements.  

EN 

45 

  EN 

 
(67)  Such  biotechnology  data  quality  accelerator  projects  should  complement  Union 
initiatives such as data labs37 and by addressing the specific data-quality requirements 
of  biotechnology,  ensuring 
that  biological  and  health  datasets  are  reliable, 
interoperable and usable for the development of advanced AI models.  

(68)  The processing of personal data by the entities that lawfully hold the relevant data and 
by  the  biotechnology  data  quality  accelerators,  in  the  context  of  biotechnology  data 
quality  accelerators  projects,  takes  place  in  the  public  interest.  The  Commission 
should  specify  in  the  decision  recognising  the  project  as  a  high  impact  health 
biotechnology  strategic  project,  the  specific  provisions  concerning  the  processing  of 
personal  data  necessary  in  order  to  achieve  the  objectives  of  the  project.  Such 
provision  may  in  particular  include  the  categories  of  data,  the  specific  roles  of  the 
parties engaged in the processing, and the entities to which the personal data may be 
disclosed.  Where  biotechnology  data  quality  accelerators  are  recognised  by  the 
Commission  through  calls  for  proposals,  the  Commission  should  be  empowered  to 
adopt, by means of an implementing act, specific provisions concerning the processing 
of personal data, through a decision prior to the launch of the call and the beneficiaries 
of the call should be subject to the obligations laid down in that decision. 

(69)  Electronic  health  data  referred  to  in  Article  51  of  Regulation  (EU)  2025/327  of  the 
European  Parliament  and  of  the  Council38,  enhanced  by  biotechnology  data  quality 
accelerators  should  be  made  available  in  accordance  with  that  Regulation.  The 
biotechnology data quality accelerators support the objectives of the European Health 
Data  Space  by  contributing  to  improving  the  quality  of  data  that  is  to  be  made 
available under that space. 

(70)  To enable innovation and competitiveness in biotechnology, it is necessary to ensure 
that  SMEs,  start-ups  and  scale-ups,  and  research  organisations  can  access  the  high 
computing capacity and AI resources required for advanced research, development and 
biomanufacturing.  Those  actions  may  be  supported 
through  Union  funding 
programmes,  funds  and  financial  instruments,  in  accordance  with  the  regulations 
governing  them.  The  Commission  should  ensure  effective  coordination  with  other 
Union  initiatives  offering  computing  capacities  to  maximise  efficiency  and  avoid 
duplication. The Commission, including through the European Biotechnology Support 
Network, should provide information and support, in particular to SMEs, start-ups and 
scale-ups,  for  accessing  high  computing  capacity  and  AI  resources  relevant  to 
biotechnology and biomanufacturing activities. 

(71)  Very  innovative  health  biotechnology  products  or  services  vary  significantly  in  the 
degree  to  which  they  align  or  can  align  with  existing  Union  legislative  frameworks 
and  procedures.  These  products,  despite  their  complexity,  should  however  be 
efficiently  and  adequately  assessed  within  a  single  regulatory  pathway,  possibly 
through  a  combination  pathway.  This  is  notwithstanding  the  fact  that  such  health 
biotechnology products  or services, in the form of preparations, devices, diagnostics, 
or  other,  for  human  use,  exhibit  characteristics  that  challenge  the  Union  legislative 

37 

38 

Proposed  in  the  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the 
European Economic and Social Committee and the Committee of the Regions, A European Strategy for 
Artificial Intelligence in Science – Paving the way for the Resource for AI Science in Europe (RAISE), 
COM(2025) 724 final of 8 October 2025. 
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the 
European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847, OJ 
L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj . 

EN 

46 

  EN 

 
 
frameworks  in  the  area  of  health  (‘health  biotechnology  products’),  for  example 
because they are under development and could potentially fall under the scope of an 
Union legislative framework but  there are questions related to  the relevance of other 
Union  legislative  frameworks;  and/or  because  they  combine  different  products, 
technologies,  processes,  or  components  regulated  under  different  Union  legislative 
frameworks; and/or because they require targeted adaptations of certain requirements 
of  the  applicable  Union  legislative  frameworks,  ideally  at  an  early  stage  of 
development. These characteristics are not mutually exclusive and may overlap.  

(72)  Developers  of  such  health  biotechnology  products  can consequently face  regulatory 
uncertainty,  potentially  delaying  or  preventing  patient  access 
to  beneficial 
technologies  and  creating  barriers  to  innovation  and  access  to  finance,  hampering 
competitiveness.  To  offer  developers  efficient  and  predictable  regulatory  procedural 
pathways, the Union legislative frameworks in the health area should be equipped with 
the  right  tools  and  should  integrate  consultative  and  collaborative  approaches,  to  be 
able to assess these health biotechnology products efficiently and timely. In addition, 
developers  of  health  biotechnology  products  should  be  supported  in  navigating 
regulatory  procedural  pathways  for  their  products  in  the  best possible  way.  This 
Regulation  should  therefore  provide  for  measures  and  facilitators  to  ensure  efficient 
pathways  to  developers  with  reduced  time-to-market,  while  safeguarding  all  existing 
provisions to protect public health.  

(73)  At  the  same  time,  the  Union  has  the  strong  experience  and  expertise  to  handle 
regulatory  complexity,  and  important  measures  to  deal  with  health  biotechnology 
products  have  already  been  proposed.  Directive  2001/83/EC  of  the  European 
Parliament  and  of  the  Council39  clarifies  which  legislative  frameworks  apply  to 
combinations  of  medicinal  products  and  other  products  and  establishes  a  single 
authorisation pathway for them. In addition, existing Union legislative frameworks in 
the  area  of  health  such  as  [revised  Regulation  (EU)  2017/745  of  the  European 
Parliament  and  of  the  Council,  [revised  Regulation  (EU)  2017/746],  [revised 
Regulation  No  (EC)  726/2004],  Regulation  (EU)  2024/1938  of  the  European 
Parliament  and  of  the  Council40  contain  specific  mechanisms  to  manage  the 
determination  of  the  regulatory  status  of  products  that  do  not  fall  clearly  within  a 
Union  legislative  framework  in  the  area  of  health.  These  mechanisms  include  the 
possibility  of  requesting  a  recommendation  or  opinion  from  the  respective  advisory 
bodies or the Agency, as applicable, at Union level, and eventually the possibility for 
binding  decisions  of  the  Commission  on  the  regulatory  status.  These  mechanisms 
should ensure predictability and conclusive opinions for products of which the status is 
being debated, avoiding cases where it remains unclear which framework applies, and 
the assessment of the product is consequently halted or delayed. 

(74)  Developers of health biotechnology products, in particular SMEs, start-ups and scale-
ups, often lack the regulatory expertise and capacity needed to identify, anticipate and 
plan  their  entry  into  the  appropriate  regulatory  procedural  pathways.  In  order  to 

39 

40 

Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community  code  relating  to  medicinal  products  for  human  use,  OJ  L  311,  28.11.2001,  p.  67,  ELI: 
http://data.europa.eu/eli/dir/2001/83/oj.  
Regulation  (EU)  2024/1938  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  on 
standards  of  quality  and  safety  for  substances  of  human  origin  intended  for  human  application  and 
(OJ  L,  2024/1938,  17.07.2024,  ELI: 
repealing  Directives  2002/98/EC  and  2004/23/EC 
http://data.europa.eu/eli/reg/2024/1938/oj). 

EN 

47 

  EN 

 
 
address  this  challenge,  the  EU  Health  Biotechnology  Support  Network,  acting  as  a 
service provider, should provide preliminary support to such developers by facilitating 
information on, and access to, applicable legislative frameworks, and should point to 
relevant opinions, recommendations, guidance and decisions. 

(75)  To allow developers to anticipate and navigate procedures to determine the regulatory 
status,  a  Union-wide  and  cross-framework  Regulatory  Status  Repository  should  be 
established.  That  Repository  should  compile  relevant  opinions,  recommendations, 
decisions  and  guidance  developed  under  the  mechanisms  established  in  the  Union 
legislative  frameworks  in  the  area  of  health  with  a  view  to  determine  the  regulatory 
status of a product. That Repository should also include the recommendations on the 
classifications of products as advanced therapy medicinal products (ATMPs) issued by 
the  Committee  for  Advanced  Therapies,  established  in  accordance  with  Regulation 
(EC) No 1394/2007 of the European Parliament and of the Council41 prior to the date 
of application of Regulation (EC) No 726/2004. Such repository should be accessible 
for  developers  and  authorities  to  enable  them  to  understand  how  similar  health 
biotechnology  products  are  evaluated in  terms of status,  and what  considerations  are 
put forward. This will guide developers and authorities, to improve efficiency, foster 
transparency,  and  ensure  consistency  and  mutual  learning  across  Union  and  national 
authorities.  This  Regulatory  Status  Repository  should  not 
include  opinions, 
recommendations, decisions and guidance on the regulatory status of AI systems and 
models within the scope of the Regulation (EU) 2024/1689. 

(76)  Existing  mechanisms  for  addressing  health  biotechnology  products,  including  those 
for  determining  their  regulatory  status  as  described  above,  provide  for  consultation 
among  various  advisory  bodies  and  the  Agency.  However,  such  procedures  are 
typically focused on individual products on a case-by-case basis. There is, therefore, a 
need for more systematic coordination across Union  legislative frameworks to  better 
identify  and  prepare  for  emerging  innovations  driving  the  development  of  health 
biotechnology  products  that  may  challenge  existing  Union  legislative  frameworks  in 
the area of health. With an expected increase in health biotechnology products entering 
the  regulatory  system,  there  is  a  growing  need  for  horizontal  foresight  anticipating 
technological developments through structured horizon-scanning activities which will 
enable the regulators to adopt regulatory approaches proactively, rather than reactively 
addressing each new difficult case. 

(77)  To  that  end,  this  Regulation  should  establish  a  Foresight  Panel  for  Emerging  Health 
Innovation to complement existing mechanisms by providing a platform for horizontal 
coordination  and  forward-looking  analysis.  The  Panel  should  conduct  horizon 
scanning to identify emerging technologies at an early stage and discuss cross-cutting 
regulatory 
informing  and  anticipating  discussions  on  health 
biotechnology  products  that  may subsequently  arise within individual  frameworks. It 
should  provide  expertise  on  emerging  science  and  technology  in  the  field  of  health 
underpinning  the  development  of  health  biotechnology  products  to  the  Commission, 
the Agency and to relevant Union-level advisory bodies and competent authorities and 
other entities in the Member States in the area of health. 

thereby 

issues, 

41 

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 
on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 
726/2004, OJ L 324, 10.12.2007, p. 121. ELI: http://data.europa.eu/eli/reg/2007/1394/oj. 

EN 

48 

  EN 

 
 
(78)  This  Panel 

should  complement,  without 

replacing,  existing  classification 
mechanisms established under  the  respective  Union  legislative  frameworks,  which 
remain  exclusively  competent  to  provide  opinions,  recommendations  or  binding 
determinations  on  the  regulatory  status  of  specific  products.  Member  States,  as 
authorities primarily responsible for decisions on regulatory status, should be closely 
involved  in  the  Panel’s  work,  sharing  practical  expertise  and  experience  to  inform 
cross-framework  dialogue,  support  harmonisation  efforts,  and  designate  experts  that 
bring the Member State perspective. 

of 

and 

that 

further 

flexibility 

necessitate 

legislation, 

(79)  Health biotechnology products increasingly challenge Union legislation  in the area of 
health 
in 
particular regarding health  biotechnology  products  that  could  be  candidates  for 
regulatory  sandboxes  under  such  frameworks.  The  development  and  implementation 
of  those  sandboxes  can  clearly  benefit  from  effective  consultation  across  the 
authorities  responsible  for  regulatory  sandboxes  falling  within  the  scope  of  Union 
legislative acts other than this Regulation. By facilitating the exchange of information 
regulatory  approaches, 
and  experiences  between 
technological  challenges,  and  emerging  scientific  understanding,  the  Union  can 
develop  more  coherent  and  responsive  regulatory  responses  to  health  biotechnology 
products.  The  activities  of  sandboxes  should  be  carried  out  in  full  compliance  of 
antitrust  information  exchanges  provisions  under  Union  competition  law.  The 
Foresight Panel for Emerging Health Innovation could play a role in promoting such 
coherence and knowledge sharing. 

including  on 

sandboxes, 

(80)  The  Commission  should  be  able  to  establish  regulatory  sandboxes  for  health 
biotechnology products which are at a very early stage of development and do not fall 
within the scope of existing Union legislative acts in the area of health, thus not being 
in a position to benefit from the regulatory sandboxes established in accordance with 
those other acts. Those sandboxes should provide a controlled environment in which 
to  explore  and  assess  innovative  technologies.  The  sandboxes  should  operate 
according  to  a  specific  sandbox  plan  that  specifies  the  duration  of  the  sandbox,  risk 
mitigation  measures  and  supervision  arrangements.  For  the  development  and 
implementation  of the sandbox plan for such products,  the Commission  may consult 
advisory bodies and Agencies established under the Union legislative acts  in the area 
of health for example to determine which requirements or rules laid down in those acts  
could, or could not, be applied to the products concerned. The outcome of the sandbox 
would be a recommendation by the Commission on an existing appropriate regulatory 
procedural pathway for authorising the product in question. The lessons learned from 
those sandboxes should lead to reflections on possible regulatory actions to be taken at 
Union  level  for  the  products  or  categories  of  products  concerned.  Accordingly,  this 
approach  would  provide  a  flexible  Union  response  to  emerging  innovations  while 
building an evidence base for potential future legislative developments.  

(81)  Biotechnologies are critical for the Union’s defence and security. Closer coordination 
between  civil  and  defence  research,  development  and  manufacturing  can  accelerate 
safe  innovation  and  reduce  fragmentation.  Therefore,  this  Regulation  should  make 
provisions for the recognition by the Commission and support of projects contributing 
to  an  EU  Biothreat  Radar  as  high  impact  health  biotechnology  strategic  projects, 
subject to conditions established in this Regulation.  

(82)  Furthermore,  this  Regulation  should  make  provisions  for  the  recognition  by  the 
Commission and support of high impact biodefence capability projects, as part of the 
category of high impact  health biotechnology strategic projects, subject to conditions 

EN 

49 

  EN 

 
laid down in this Regulation. Such projects should make a significant contribution to 
objectives  such  as  the  prevention  or  mitigation  of  the  misuse  of  biotechnologies.  As 
such, those projects should benefit from priority status in administrative procedures in 
accordance  with  this  Regulation  and  could  be  given  particular  consideration  for 
support  under  national  and  Union  funding  programmes  and  instruments,  including 
from those budgets allocated to defence. 

(83)  Without prejudice to Member States’ competences and in accordance with the Union 
funding  programmes  and  instruments,  biotechnology  activities  relevant  to  defence, 
security,  safety,  preparedness,  and  resilience,  including  dual-use  technologies  could  
be given particular consideration, where appropriate, for support under the European 
Defence Fund, the Union Research Framework Programmes and other Union funding 
instruments. 

(84)  Moreover,  where  national  authorities  so  decide,  expenditure  on  such  dual-use 
infrastructures  and  related  biodefence  activities  may  be  counted  toward  relevant 
defence spending targets. 

(85)  The  biotechnology  landscape  is  evolving  at  an  unprecedented  speed,  driven  by 
advances  in  synthetic  biology  and  genome  editing,  which,  coupled  with  AI,  make 
biotechnology  stand  at 
innovation,  offering  unprecedented 
opportunities  for  advancing  health  and  protecting  against  biological  threats.  These 
advances  also  make  biotechnological  misuse  faster,  cheaper,  and  more  accessible. 
Biotechnologies  can  pose  serious  and  distinctive  risks  that  call  for  continuous 
assessment  and  anticipatory  safeguards.  Therefore,  a  limited  set  of  biotechnology 
products  with  significant  potential  for  misuse  (‘biotechnology  products  of  concern’) 
require a specific framework to prevent and protect against their misuse.  

the  forefront  of 

(86)  Union  and  international  rules  address  certain  aspects  related  to  biological  threats, 
biological incidents or biological risks, in particular in relation to serious cross-border 
threats  to  health42,  the  control  of  exports,  brokering,  technical  assistance,  transit  and 
transfer  of  dual-use  items43,  resilience  in  biosafety  and  biosecurity  through  the 
Biological  and  Toxin  Weapons  Convention  (BTWC)44,  the  Chemical  Weapons 
Convention  (CWC),  the  contained  use  of  genetically  modified  micro-organisms45, 
workers’  protection  from  risks  related  to  exposure  to  biological  agents  at  work46,  in 
relation to  AI systems and models through Regulation (EU) 2024/1689. However, the 

42 

43 

44 

45 

46 

threats 

to  health  and 

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on 
serious  cross-border 
repealing  Decision  No  1082/2013/,  p.  26. 
ELI: http://data.europa.eu/eli/reg/2022/2371/oj.  
Regulation (EU) 2021/821 of the European Parliament and of the Council of 20 May 2021 setting up a 
Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use 
items , OJ L 206, 11.6.2021, pp. 1. ELI: http://data.europa.eu/eli/reg/2021/821/oj. 
Council Decision (CFSP)  2023/2636 of 20 November 2023 amending Decision (CFSP)  2021/2072 in 
support of building resilience in biosafety and biosecurity through the Biological and Toxin Weapons 
Convention, 
ELI: 
http://data.europa.eu/eli/dec/2023/2636/oj 
 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained 
use of genetically modified micro-organisms (Recast) (Text with EEA relevance), OJ L 125, 21.5.2009, 
p. 75. ELI: http://data.europa.eu/eli/dir/2009/41/oj. 
Directive  2000/54/EC  of  the  European  Parliament  and  of  the  Council  of  18  September  2000  on  the 
protection  of  workers  from  risks  related  to  exposure  to  biological  agents  at  work  (seventh  individual 
directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 262, 17.10.2000, p. 21. 
ELI: http://data.europa.eu/eli/dir/2000/54/oj. 

22.11.2023, 

2023/2636, 

longer 

force. 

OJ 

no 

L, 

in 

EN 

50 

  EN 

 
 
 
approach  remains  fragmented  and  does  not  sufficiently  address  all  aspects  related  to 
the  misuse  related  to  biotechnologies.  A  consistent  and  high  level  of  protection 
throughout the Union should therefore be ensured in order to guarantee biotechnology 
remains  trustworthy  and  provides  legal  certainty  for  economic  operators  in  the 
biotechnology sector.  

(87)  There  are  divergent  requirements  in  Member  States  for  screening,  verification, 
reporting  and  tracking  of  suspicious  transactions  for  biotechnology  products  of 
concern, which includes benchtop equipment and sequences of concern. This lack of 
harmonisation  creates  additional  costs  for  economic  operators,  especially  for  those 
with strong security systems in place, and might distort competition within the internal 
market as well as potentially create barriers to trade and innovation.  

(88)  A  Union  framework  for  strengthening  monitoring  of  the  potential  misuse  of 
biotechnology  products  of  concern  is  therefore  needed  and  requested  by  industry 
actors, including SMEs, to safeguard the free movement of goods and ensure a level 
playing field in the internal market. This framework needs to take into account recent 
international  developments  and  good  practices  in  other  jurisdictions  and  relevant 
industry consortia and standard-setting fora, including to promote interoperability for 
Union operators active globally and providing for a level playing field in the internal 
market. 

(89)  To  ensure  that  oversight  remains  proportionate  and  appropriately  calibrated  to  the 
risks,  and  in  line  with  existing  Union  harmonisation  legislation,  the  complementary 
harmonisation measures established in this Regulation to prevent misuse should only 
apply to a limited subset of biotechnology products of concern which pose the highest 
risk  of  misuse,  and  whose  misuse  has  the  highest  consequences,  such  as  certain 
sequences  of  concern  or  benchtop  nucleic  synthesis  equipment  able  to  create  such 
sequences  of  concern.  For  the  purposes  of  legal  clarity  and  certainty,  such  products 
should  be  listed  in  Annex  I  to  this  Regulation.  As  biotechnology  will  continue  to 
rapidly  evolve,  the  Union  framework  should  remain  flexible  and  capable  of 
responding  to  emerging  biotechnology  products,  materials,  and  scientific  evidence 
regarding  potential  risks.  Therefore,  the  Commission  should  be  empowered  to  adopt 
delegated  acts  to  amend  Annex  I  to  respond  swiftly  to  scientific  and  security 
developments and in consultation with relevant experts including the Advisory Group 
on  Biosecurity  established  under  this  Regulation,  while  following  the  existing 
international and other relevant regulatory frameworks 

(90)  The Union framework should be comprehensive to apply to the making available to, 
introduction,  or  use  of,  biotechnology  products  of  concern,  by  any  natural  or  legal 
person in the Union as well as to the making available to any natural or legal person 
outside the Union.  

(91)  To reduce risks at the point of sale within the Union, economic operators should verify 
the  legitimate  need  and  peaceful  purposes  of  prospective  customers  before  making 
available  the  biotechnology  products  of  concern  included  in  Annex  I  to  this 
Regulation.  

(92)  Apart from economic operators, other natural and legal persons that are not economic 
operators, including  researchers, laboratories,  universities, or research institutes, may 
also make available and use biotechnology products of concern. Such persons should 
be subject to the same screening obligations as economic operators, while preserving 
freedom  of  research  and  academic  freedom  in  accordance  with  Article  13  of  the 
Charter of Fundamental  Rights of the European Union and Article 179 of the Treaty 

EN 

51 

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on the Functioning of the European Union, except where knowledge and material are 
shared with persons employed within the same legal entity. Biotechnology products of 
concern should not be made available to members of the general public.  

(93)  Benchtop  nucleic  acid  synthesis  equipment  poses  a  particular  challenge  to  the 
verification  of  legitimate  need  and  the  tracking  and  monitoring  of  sequences  of 
concern. Such equipment should therefore contain an automatic mechanism to screen 
for sequences of concern. 

(94)  This  Regulation  should  lay  down  provisions  requiring  economic  operators  to  report 
suspicious  transactions  throughout  the  supply  chain,  regardless  of  whether  the 
prospective  customer  is  a  member  of  the  general  public  or  an  economic  operator, 
private  or  public,  and  should  apply  in  relation  to  biotechnology  products  that  are 
considered  of  concern  provided  the  risk  or  threat  they  may  pose,  which  includes 
certain sequences of concern and biotechnology products. Reporting and recording for 
three years the suspicious transactions would allow other operators to be aware of the 
risks  of  the  concerned  product,  while  avoiding  duplicate  reporting,  and  allowing 
authorities to monitor and assess the risks and verify compliance with the obligations 
laid down in this Regulation. 

(95)  Suspicious  transactions  should  be  detected  and  reported  rapidly  through  harmonised 
procedures, with Member States designating national contact points that provide clear 
reporting  channels,  as  well  as  record  data  and  ensure  compliance,  with  a  view  to 
contributing to safeguarding national and Union’s safety. 

(96)  Where a biotechnology product of concern falls also under categories regulated under 
other  Union  legislation,  to  avoid  duplication  of  reporting,  where  a  suspicious 
transaction of that biotechnology product of concern has already been reported under 
one legal framework, it should not be reported again. 

(97)  Licensed  biotechnology  products  containing  nucleic  acid  sequences,  including 
authorised medicinal products for human and veterinary use, should not be subject to 
verification of legitimate need, as they have undergone regulatory assessment and do 
not  constitute  independent  biological  threats.  However,  the  stand-alone  nucleic  acid 
sequences in synthetic form should fall within the scope of legitimate-need screening, 
as they may be misused and be relevant to biosecurity oversight. 

(98)  Certain tools with a potential to be misused without further modification and to cause 
serious  harm  to  public  health  and  safety,  agricultural  crops  and  other  plants,  to 
animals,  the  environment,  material  or  government  security  (dual-use  research  of 
concern  - ‘DURC’) are increasingly affordable and accessible, also through progress 
in  AI  capabilities,  which  elevates  the  risk  of  misuse  by  actors  lacking  appropriate 
competence,  oversight,  legitimate  or  peaceful  intent.  A  proportionate  and  risk-based 
framework  is  therefore  necessary  to  minimise  opportunities  for  misuse  of  DURC, 
including  on  AI  models  in  biological  applications,  while  preserving  legitimate 
research and innovation.  

(99)  Supervision by the public authorities is needed to ensure that research, innovation and 
commercial operations are conducted responsibly and securely. This in turn can build 
public trust in biotechnology. Effective supervision requires adequately resourced and 
trained  national 
investigative  powers, 
complemented  by  risk-based  audits  to  verify  the  effectiveness  of  the  screening 
obligations laid down in this Regulation, as well as training and awareness-raising for 
the  staff  of  the  designated  inspection  authorities  and  stakeholders,  and  regular 

inspection  authorities  with  adequate 

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exchanges  among  inspection  authorities and  economic operators, including operators 
involved in online marketplaces. Moreover, Member States should lay down rules on 
penalties  applicable  to  infringemens  of  the  provisions  laid  down  in  this  Regulation 
regarding the prevention of biotechnology misuse. Such penalties should be effective, 
proportionate and dissuasive.  

(100)  The Commission should monitor Member States in the enforcement of this legislation, 
including by requesting information and records to check the screening and suspicious 
transaction reporting frameworks of economic operators.  

(101)  Considering the evolving biosecurity landscape and the misuse risks of biotechnology 
products  of  concern,  this  Regulation  should  establish  an  Advisory  Group  on 
Biosecurity  (‘the  Advisory  Group’)  to  monitor  the  landscape  of  biological  risks  and 
alert the Commission when it identifies new biotechnology products of concern.  The 
Advisory  Group  should  complement  the  work  of  existing  expert  groups  in  health 
security.  It  should  be  composed  of  globally  leading  independent  scientists.  Its 
members should be selected and operate in accordance with the Commission Decision 
of  30  May  2016  establishing  horizontal  rules  on  the  creation  and  operation  of 
Commission expert groups. The members of the Advisory Group should be appointed 
by the Commission based on up-to-date scientific or technical expertise in the area of 
biosecurity, biodefence and AI.  

(102)  AI offers significant potential to enhance the Union’s competitiveness and innovation 
capacity, including in the area of biotechnology.  This potential should be realised in a 
safe  and  responsible  manner.  In  this  regard,  Regulation  (EU)  2024/1689  lays  down 
harmonised rules for placing on the market putting into service and use of AI systems 
and  models  in  the  Union,  prohibitions  of  certain  AI  practices,  harmonised 
transparency  rules  for  certain  AI  systems,  rules  on  market  monitoring,  market 
surveillance, governance and enforcement as well as measures to support innovation. 
AI systems and general-purpose AI models can lower the barrier for actors to misuse 
biotechnology.  The  provisions  of  Regulation  (EU)  2024/1689  governing  AI  systems 
and general-purpose AI models aim to mitigate this. Further, AI models, as described 
in Regulation (EU) 2024/1689, used in biological applications, that are not covered by 
Regulation  (EU)  2024/1689    (‘AI  models  in  biological  applications’)  can  also  pose 
risks, including different types of systemic biological risks.  

(103)  AI  models  in  biological  applications  encompass  both  specialised  tools  and  more 
general models  trained on large datasets  of biological  sequences that can be  adapted 
for a variety  of downstream  tasks. Such models  in  biological  applications can aid  in 
the development of novel, more dangerous biological threats, increasing the ceiling of 
harm  of  biotechnology  misuse.  Capabilities  of  such  AI  models  in  biological 
applications  therefore  need  to  be  monitored,  investigating  and  assessing  risks  to 
identify  any  models  posing  biological  systemic  risks  and  ensuring  necessary  risk 
mitigation measures are taken. In addition, systemic resilience would need to improve 
to prevent, detect and respond to any misuse incidents. 

(104)  The  Advisory  Group  should  therefore  monitor  the  capabilities  of  AI  models  in 
biological  applications,  working  closely  with  scientists  and  companies  developing 
such  models  and  should  be  tasked  to  issue  a  qualified  alert  to  the  Commission  if  it 
identifies that an AI model in biological applications not covered by Regulation (EU) 
2024/1689  poses  biological  systemic  risk.  The  Advisory  Group  should  inform  the 
Scientific  Panel  of  independent  experts  established  under  Article  68  of  Regulation 
(EU) 2024/1689, if it has reasonable grounds to suspect that an AI model covered by 

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that  Regulation  poses  biological  systemic  risks.  That    panel  could  in  turn  issue  a 
qualified  alert  to  the  AI  Office  in  accordance  with  Regulation  (EU)  2024/1689. 
Considering  that  the  AI  Office  established  by  Commission  Decision  C(2024)  39047 
has as its mission to develop Union expertise and capabilities in the field of AI and to 
contribute to the implementation of Union law on AI, that office should participate in 
the establishment of the Advisory Group.   

(105)  The  European  Health  Biotechnology  Steering  Group  established  by  this  Regulation 
should  also  ensure  proper  coordination  and  information  exchanges  among  Member 
States on the enforcement of the biosecurity provisions in this Regulation, consulting 
the  Advisory  Group,  other  relevant  existing  bodies  and  external  experts  where 
appropriate. 

(106)  This  Regulation  should  establish  a  framework  of  measures,  in  particular  for  health 
biotechnology  strategic  projects  and  high  impact  health  biotechnology  strategic 
projects, to ensure the growth of the health biotechnology sector. This Regulation and, 
in particular, the measures in Chapters II to VIII, should serve the aim of creating and 
reinforcing  favourable  conditions  for  health  biotechnology,  from  research  and 
development  to  the  timely  placing  on  the  Union  market  and  production  of 
biotechnology innovations and products. The pathway to placing on the the market of 
health  biotechnology  innovations  and  products  are  governed  by  important  and 
comprehensive  sets  of  regulatory  rules  and  procedures.  Reviewing  and  streamlining 
these  rules  and  procedures  is  an  inherent  part  to  achieve  the  aim  of  facilitating  and 
accelerating  the  development,  placing  on  the  market  and  production  of  health 
biotechnology innovations and products. The practical effectiveness of the measures of 
this Regulation, in particular those in Chapters II to VIII, depends to a large extent on 
a  review  and  streamlining  of  certain  rules  and  procedures  applicable  to  health 
biotechnology innovations and products so as to facilitate timely access to the market. 
As  set  out  in  recitals  [5 to  7],  health  biotechnology  must  be  understood broadly  and 
encompasses  also  the  veterinary  and  phytosanitary  fields  which  have  as  their  direct 
objective the protection of public health. 

(107)  For instance, a timelier and facilitated risk assessment process for products subject to 
pre-market  authorisation  in  accordance  with  Union  food  law,  accelerated  procedures 
and  measures  facilitating  innovation,  such  as  measures  on  regulatory  sandboxes  are 
needed for the efficiency of the facilitation measures laid down in this Regulation.  

(108)  Regulation  (EC)  No  178/2002  lays  down  the  general  principles  and  requirements  of 
food  law,  so  as  to  form  a  common  basis  for  measures  governing  food  law  at  both 
Union  and  national  level.  For  the  purposes  of  risk  assessment  at  Union  level,  it 
establishes  the  European  Food  Safety  Authority  (‘the  Authority’),  as  the  responsible 
Union risk assessment body in matters primarily relating to food and feed safety. 

(109)  Considering  the  increasing  prevalence  of  diet-related  health  issues,  it  is  essential  to 
expand the Authority’s mandate to encompass all aspects of nutrition and to enable it 
to provide advice concerning the nutritional properties of food products and practices, 
including those derived from advanced biotechnological processes.  

(110)  It has been observed that a significant number of application and notification dossiers 
submitted  to  the  Authority  are  either  incomplete  or  do  not  meet  the  applicable 

47 

Commission  Decision  of  24.1.2024  establishing  the  European  Artificial  Intelligence  Office  C(2024) 
390.  

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regulatory  and  scientific  specifications  requirements  to  enable  the  best  quality 
scientific assessment by the Authority, resulting in the need for requests for additional 
information  during  the  risk  assessment  process  and,  consequently,  leading  to 
sometimes  significant  delays.  This  is  also  the  case  where  biotechnology  innovations 
and  products  are  concerned,  as  such  products  would  benefit  strongly  from  pre-
submission  scientific  advice  on  study  design  and  testing  strategies.  Applicants  or 
notifiers  of  such  products,  in  particular  small  and  medium-sized  enterprises  do  not 
always  have  a  clear  understanding  of  the  applicable  regulatory  and  scientific 
requirements  when  compiling  application  dossiers,  in  particular  as  regards  the  types 
and  details  of  studies  to  conduct.  It  is  thus  appropriate  to  enlarge  the  scope  of  the 
general pre-submission advice provided by the Authority at the request of a potential 
applicant  or  notifier  to  encompass  non-committal  advice  on  regulatory  aspects 
including  applicable  rules  and  guidance  documents,  as  well  as  scientific  advice  on 
study  design  and  testing  strategies.  This  advice  should  be  provided  by  the  staff  and 
experts  of  the  Authority  to  ensure  the  most  updated  scientific  advice.  Given  the 
broadening  of  the  scope  of  the  general  pre-submission  advice  which  is  already 
available  for  both  new  and  renewals  of  approvals/authorisations,  it  is  no  longer 
necessary to provide for a specific pre-submission advice for renewals.  

(111)  Practice  has  shown  that  the  existing  procedural  consequences  in  the  event  of  non-
compliance  with  the  notification  requirement  of  commissioned  studies  at  pre-
submission  phase  appear  to  be  too  severe,  particularly  for  small  and  medium-sized 
enterprises, and could impede competitiveness and innovation in the food chain. It is 
therefore necessary to shorten the existing procedural consequence in the event of non-
compliance  from  six  months  to  three  months  following  the  re-submission  of  the 
relevant application or notification.  

(112)  In  order  to  strengthen  the  coherence  of  risk  assessments  carried  out  by  different 
Scientific  Panels  within  the  Authority,  foster  stronger  synergies  and  promote  greater 
harmonisation  across  guidance  documents  and  scientific  opinions,  for  the  benefit  of 
applicants  while  enhancing  the  effectiveness  and  efficiency  of  the  Authority’s  risk 
assessment  processes,  it  is  appropriate  that  the  staff  of  the  Authority  chairs  the 
Scientific  Committee  and  the  Scientific  Panels,  without  voting  rights.  The  Scientific 
Committee should continue to be composed by experts.  

(113)  The food and feed sector is experiencing rapid technological advancements, including 
biotechnology,  AI,  smart  farming  techniques,  development  of  new  approach 
methodologies,  that  could  contribute  to  reduction  of  animal  testing  and  circular 
economy practices promoting resource efficiency and waste reduction. It  is therefore 
appropriate  to  provide  Member  States  with  the  possibility  of  setting  up  regulatory 
sandboxes  that  can  provide  an  environment  for  the  testing  of  those  innovations  in  a 
controlled  manner,  incentivising  research  and  development,  whilst  allowing  for 
adaptive regulatory practices that can be modified based on feedback and results from 
live trials. Regulation (EC) No 178/2002 should therefore be amended accordingly.  

(114)  Given the diversity of sectors covered by Union food law, and the fact  that Member 
States  have  diverse  food  systems,  cultural  preferences,  local  market  conditions,  and 
research  and  risk  assessment  bodies,  regulatory  sandboxes  should  be  established  a 
national level in order to ensure the necessary flexibility to allow for experimentation 
specifically tailored to address local needs, preferences, and consumer behaviours. For 
the  same  reasons,  and  in  order  to  support  innovation  along  the  whole  food  chain, 
regulatory sandboxes should be allowed also at retail level and, thus, making available 
products  under  the  regulatory  sandboxes  to  food  business  operators  or  consumers 

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should not  be considered as placing  on the market.  However, in  order to ensure that 
the  establishment  of  regulatory  sandboxes  does  not  jeopardise  food  safety  or 
consumers’ information and that they are established and function in such a way as to 
enable  the  collection  of  sound  and  useful  information  to  inform  future  regulatory 
changes,  rules  should  be  laid  down  concerning  the  objectives  pursued  within  
regulatory  sandboxes,  the  modalities  for  their  adoption,  amendment  and  revocation, 
the control of the activities carried out under the regulatory sandbox, monitoring and 
reporting as well as rules ensuring the protection of human and animal health and of 
the environment. 

(115)  Regulatory sandboxes should not be allowed for some products. Experience has shown 
that  certain  types  of  novel  foods  trigger  ethical  or  cultural  concerns  among  various 
consumer  segments  regarding  their  acceptability.  Since  those  aspects  are  best 
addressed  within  the  applicable  rigorous  regulatory  framework  established  by 
Regulation  (EU)  2015/2283  of  the  European  Parliament  and  of  the  Council48,  it  is 
appropriate to exclude novel foods from the scope of regulatory sandboxes. For GMOs 
legal pathways exist to allow testing of innovations, such as under Part B of Directive 
2001/18/EC  on  the  deliberate  release  of  genetically  modified  organisms  (GMOs)  for 
purposes  other  than  placing  on  the  market,  and  there  should  not  be  a  duplication  of 
paths in order to maintain legal certainty. For this reason, regulatory sandboxes should 
be  restricted  to  products  containing  or  consisting  of  GMOs  subject  to  authorisation 
under  Part  C  of  Directive  2001/18/EC.  As  regards  innovations  concerning  novel 
plastic  recycling  technologies  for  plastics  intended  to  come  into  contact  with  food, 
chapter  IV  of  Commission  Regulation  (EU)  2022/161649  already  establishes  a 
framework  that  is  meant  to  encourage  the  development  of  such  novel  technologies 
without  prior  authorisation.  To  ensure  uniform  rules  on  the  development  of  novel 
recycling technologies that safeguard the health of the consumers, it is appropriate to 
exclude the development of recycling technologies from the possible use of regulatory 
sandboxes  and rely  instead on the procedure  established in  chapter  IV of Regulation 
(EU) 2022/1616. 

(116)  To  ensure  uniform  conditions  and  principles  for  the  setting  up,  operation  and 
supervision  of  Regulatory  sandboxes,  implementing  powers  should  be  conferred  on 
the Commission in the context of Regulation (EC) No 178/2002. Those implementing 
powers  should  be  exercised  in  accordance  with  Regulation  (EU)  182/2011  of  the 
European  Parliament  and  of  the  Council50.  In  case  of  emergencies,  the  Commission 
may  provisionally  adopt  an  measures  in  accordance  with  an  urgency  procedure 
requesting the suspension of the regulatory sandbox concerned. 

48 

49 

50 

(EC)  No  1852/2001 

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
and  repealing  Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  and 
Commission  Regulation 
(OJ  L  327,  11.12.2015,  p.  1,  ELI: 
http://data.europa.eu/eli/reg/2015/2283/oj). 
Commission  Regulation  (EU)  2022/1616  of  15  September  2022  on  recycled  plastic  materials  and 
articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (OJ L 
243, 20.9.2022, p. 3, ELI: http://data.europa.eu/eli/reg/2022/1616/oj). 
Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
laying down the rules and general principles concerning mechanisms for control by Member States of 
implementing  powers  (OJ  L  55,  28.2.2011,  p.  13,  ELI: 
the  Commission’s  exercise  of 
http://data.europa.eu/eli/reg/2011/182/oj). 

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(117)  Considering  the  additional  financial  burden  established  on  the  Authority  with  the 
expansion  of  its  mandate  following  the  amendments  set  out  in  this  Regulation,   the 
possibility  of  establishing  fees  in  order  to  fully  or  partially  fund  EFSA’s  new  tasks 
could be considered. 

(118)  Clinical  trials  with  advanced  investigational  therapy  medicinal  products  (ATMPs), 
including  those  consisting  or  containing  genetically  modified  organisms  (GMOs) 
within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament 
and of the Council51, can provide early access to transformative treatments for patients 
with  rare  or  otherwise  untreatable  conditions  and  are  important  to  prepare  for  the 
marketing authorisation of the medicinal products for such treatments. The nature and 
design of certain advanced investigational therapy medicinal products is such that the 
risks  to  human  health  and  the  environment  resulting  from  a  deliberate  release  of  a 
GMO into the environment are, in practice, either excluded or negligible. For example, 
in viral vectors, which are genetically modified viruses used to deliver genetic material 
into  cells,  the  wild-type  virus  genome  is  largely  removed  resulting  in  replication-
defective  recombined  particles.  As  these  particles  cannot  reproduce  themselves,  they 
present at most a negligible risk to human health and the environment. 

investigational 

therapy  medicinal  products  from 

(119)  Consequently,  when  controlling  under  Regulation  (EU)  No  536/2014  for  risks  from 
the  deliberate  release  into  the  environment  of  GMOs,  a  risk-proportionate  approach  
should be applied and Regulation (EC) No 1394/2007 should be amended with respect 
to certain, clearly delineated categories of advanced investigational therapy medicinal 
products that consist or contain GMOs, which present no or negligible risks to human 
health and the environment. Whilst it is appropriate to exempt such clearly delineated 
categories  of  advanced 
the 
requirement  to  submit  an  environmental  risk  assessment,  sponsors  of  clinical  trials 
should,  however,  submit  a  declaration  as  part  of  the  clinical  trial  application  that 
explains why the advanced investigational therapy medicinal products concerned falls 
into one or more of the specific categories of products presenting no or negligible risks 
to  human  health  and  the  environment.  The  Committee  for  Medicinal  Products  for 
Human  Use  (CHMP)  referred  to  in  Article  [148]  of  Regulation  […]  [revised 
Regulation  No  (EC)  726/2004]  should  verify  this  declaration.  For  the  same 
considerations  of  a  risk-proportionate  approach,  the  above-mentioned  categories  of 
advanced investigational therapy medicinal products should also be exempted from the 
requirements  of  Regulation  (EU)  No  536/2014  regarding  manufacturing  and  import. 
Annex  I  to  the  Regulation  (EU)  No  536/2014  should  also  be  amended  to  ensure 
consistency  with  the  aforementioned  amendments  to  the  Regulation  (EC)  No 
1394/2007.  

(120)  Scientific and technological advances are driving the development of advance therapy 
medicinal products (ATMPs). To future proof the ATMPs legislative framework, the 
power  to  adopt  delegated  acts  should  be  delegated  to  the  Commission  to  amend 
Regulation  (EC)  No  1394/2007,  by  clarifying  the  definition,  without  extending  its 
scope,  of  what  constitutes  a  tissue  engineered  product,  in  light  of  technical  and 
scientific advancements in the field of ATMPs. To that effect, the Commission should 
carry  out  appropriate  consultations  of  the  Agency  and  of  the  Substances  of  Human 
Origin Coordination Board (‘the SCB’).  

51 

Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive 90/220/EEC, OJ L 106, 17.4.2001, p. 1, ELI: http://data.europa.eu/eli/dir/2001/18/oj .  

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(121)  The measures established in this Regulation, including regarding health biotechnology 
strategic  projects  and  high  impact  health  biotechnology  strategic  projects,  access  to 
funding,  biosimilars  and  the  application  of  artificial  intelligence  in  the  health 
biotechnology  sector  aim  to  strengthen  the  health  biotechnology  sector.  Those 
measures aim to foster research, development, testing, and preparing for market entry 
of  health  biotechnology  products  and  services.  This  is  the  case  for  the  centres  of 
excellence for advanced therapies, the overall aim of which is to accelerate the placing 
on  the  market  of  advanced  therapies,  accelerate  clinical  translation,  improve  quality 
control  and  facilitate  patient  access  across  the  Union.  Similarly,  the  biotechnology 
development accelerators aim to provide trusted testing or demonstration facilities for 
process  testing,  validation,  and  small  batch  manufacturing,  including  for  the  initial 
phases  of  clinical  trials.  Similarly,  time  to  market  for  biotechnology  products  is  one 
key factor that impacts investments in the sector and accordingly access to funding for 
developers and start-ups in the biotechnology sector. Many of the products subject to 
those  measures  are  expected  to  be  biological  medicinal  products  (‘biologicals’),  for 
which  clinical  research  and  trials  are  an  essential  step  on  their  way  to  the  market. 
Therefore, the measures established in this Regulation, in particular on biotechnology 
health  strategic  projects  and  high  impact  health  biotechnology  strategic  projects,  are 
intrinsically intertwined with, and depend on, the strengthening of clinical research in 
Europe.  This  is  because  all  biotechnology  products  expected  to  be  developed  or 
supported through the  health  biotechnology  strategic projects  and high  impact  health 
biotechnology  strategic  projects  are  depending  to  a  very  large  extent  on  an  efficient 
and vibrant ecosystem of clinical research in the Union.  

(122)  Amending  Regulation  (EU)  No  536/2014  of  the  European  Parliament  and  of  the 
Council52 to bring simplification and shorten the time for biotechnology innovations to 
reach the Union market is crucial to streamline and accelerate clinical trials processes 
in  the  Union  and  to  make  the  legislative  framework  competitive  globally  so  as  to 
attract  more  clinical  research  to  the  Union.  Without  an  efficient,  accelerated  and 
streamlined  legislative  framework  for  clinical  trials  authorisation  in  the  Union,  the 
other measures in this Regulation, and in particular the framework for the recognition 
and  support  of  health  biotechnology  strategic  projects  and  high  impact  health 
biotechnology strategic projects would be deprived of their effectiveness, as all health 
biotechnology  medicinal  products  require  state  of  the  art  clinical  research  and  a 
globally competitive regulatory framework for clinical trials authorisation. 

(123)  The clinical  trials  offer  early access  to  the most innovative therapies,  contribute to  a 
sustainable healthcare system, maintain scientific excellence and specialised skills and 
they  also  support  prosperity  in  the  Union.  Enabling  the  development  of  innovative 
biological  medicines  through  clinical  trials  is  particularly  important,  since  those 
medicines  often  provide  life-saving  therapeutic  options,  including  in  cancer  care  or 
against  rare  genetic  conditions,  and,  due  to  their  complexity,  they  are  often  more 
difficult and expensive to develop. Increased clinical trials in the Union for biological 
medicines  could  potentially  contribute  to  more  manufacturing  in  the  Union,  higher 
number  and  earlier  regulatory  submission  of  biological  medicines  for  marketing 
authorisation  applications  and  higher  percentage  of  EU  clinical  data  in  marketing 
authorisation  applications.  In  relation  to  this,  biological  medicines  sales  are  key 

52 

Regulation  (EU)  No  536/2014  of  the  European  Parliament  and  of  the  Council  of  16  April  2014  on 
clinical  trials  on  medicinal  products  for  human  use,  and  repealing  Directive  2001/20/EC  (OJ  L  158, 
27.5.2014, p. 1, ELI: http://data.europa.eu/eli/reg/2014/536/oj). 

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drivers of growth. In 2024, the European Union spent €228 billion on medicines at list 
prices,  including  €95  billion  on  biological  medicines,  which  now  comprise  41%  of 
total pharmaceutical spending. Spending on biological medicines continues to outpace 
that  of  small  molecules  (~5%)  by  3x  and  the  total  prescription  market,  at  a  rate  of 
14.7%  in  the  most  recent  period53.    In  this  context,  simplifying  Regulation  (EU)  No 
536/2014 and accelerating multinational clinical trials appears necessary with a view 
to  accelerate  time  to  market  of  heath  biotechnology  innovations  and  thus  secure  the 
effectiveness of the substantive provisions laid down in this Regulation.  

(124)  At  the  same  time,  Regulation  (EU)  No  536/2014  applies  to  all  clinical  trials 
irrespective of the type of investigational medicinal product, whether it be biological 
or  chemical  molecules.  However,  the  amendments  to  Regulation  (EU)  No  536/2014 
through  this  Regulation,  for  streamlining  and  simplifying  that  Regulation,  are 
particularly  relevant  for  biologicals.  This  is  because  the  development  of  biologicals 
relies heavily on multinational clinical trials to be able to recruit the necessary number 
of patients.  

(125)  Moreover,  the  limitation  of  the  scope  of  the  envisaged  amendments  to  biologicals 
would  be  against  the  core  principle  of  Regulation  (EU)  No  536/2014  to  create  a 
harmonised  EU-level  system  for  clinical  trials  authorisations.  It  would  create  two 
authorisation  pathways  for  chemical  medicines  and  biologicals  and  it  would  not  be 
appropriate to distinguish these procedurally, considering the coordinated assessment 
procedure established in Regulation (EU) No 536/2014 and the single  EU Portal and 
database as  IT  system  provided for in  that Regulation  for the electronic  submissions 
and  assessment  of  all  applications.  In  addition,  providing  for  different  timelines  for 
biological  and  chemical  medicines could  create uncertainty for  developers and could 
be perceived as creating double standards for clinical research on medicines, where the 
biotechnology  products,  often  more  complex,  would  benefit  from  shorter  and  more 
streamlined  timelines.  Such  fragmented  approach  could  potentially  also  increase  the 
burden on regulators and could lead to different national interpretations regarding the 
implementation  of  the  respective  authorisation  procedures.  This  in  turn  would  risk 
putting  multinational  clinical  trials  at  disadvantage  with  more  associated  negative 
effects for biological development. Further, such an approach could have a particularly 
negative impact on combination trials testing combination medicinal products, where 
biological  and  chemical  active  substances  are  combined  within  a  single 
pharmaceutical  form,  to  treat  debilitating  medical  conditions  for  example  but  not 
limited to breast, lung, colorectal cancers or autoimmune diseases, as well as on trials 
comparing  a  biological  and  a  chemical  medicinal  products  or  on  trials  using  a 
chemical medicine as a standard of care treatment in the control arm . Consequently, 
the amendments to Regulation (EU) No 536/2014 should apply to both biologicals and 
chemicals.  

(126)  The Union has unique advantages as a place for multinational clinical trials due to its 
large  population,  rich  genetic  diversity,  scientific  excellence  and  robust  research 
infrastructures, and high ethical, quality and safety standards. To fully leverage these 
strengths and considering the key and increasing role of research and clinical trials for 
a  thriving  health  biotechnology  sector,  it  is  necessary  to  amend  the  Regulation  (EU) 
No 536/2014 to further streamline and speed up the authorisation processes especially 
for multinational clinical trials.  

53 

See figure 2, EU spending growth at list price levels by segment and leading therapy area, in Annex to 
this document.  

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(127)  To accelerate and streamline the approval processes in multinational clinical trials it is 
necessary  to  give  a  stronger  leading  role  to  the  reporting  Member  State  and  further 
strengthen the principles of mutual trust and reliance. The assessment by the reporting 
Member State, including of the ethical aspects of the trial, should serve as a reference 
for the other Member States concerned. Member States concerned should complement 
the assessment by the reporting Member State only when necessary, and be entitled to 
raise  considerations  from  ethical,  relevant  national  law  or  national  standard  of  care 
perspectives.  Strengthening  reliance  on  the  reporting  Member  State’s  assessment 
would reduce duplication of work and allow Member States and sponsors to allocate 
resources more effectively, while ensuring high level of protection of subjects and the 
robustness of data. 

(128)  Defined timelines in the context of clinical trials approval are necessary to guarantee 
speed  and  enhance  predictability  of  the  authorisation  process,  especially  for 
multinational  clinical  trials.  Defined  maximum  timelines  should  allow  the  Member 
State  authorities  with  efficient  planning  to  reduce  periods  of  inactivity  and  thus 
regulatory  delays  between  the  assessment  phases  and  enable  short  procedure  for 
clinical trial approval overall. Stronger reliance on the reporting Member State would 
also  result  in  efficiency  gains,  improve  resource  allocation  and  would  enable  the 
shortening  of  the  consecutive  assessment  steps  without  compromising  the  quality  of 
the assessments. It would benefit the sponsors as well, as it will result in a quicker start 
of  a  clinical  trial,  as  well  as  in  increased  transparency  and  predictability  for  more 
effective  planning.  To  reduce  regulatory  bottlenecks  by  allowing  coordinated 
interaction between Part I and Part II assessments in multinational clinical trials, their 
respective assessment timelines should be aligned.  

(129)  Recognising the importance of advanced therapeutic medicinal products (ATMPs) as 
drivers of innovation in biotechnology and regenerative medicine, it is appropriate to 
introduce  a  series  of  regulatory  provisions  to  simplify  and  shorten  the  timelines  for 
authorisation of clinical trials in the Union. In particular, to accelerate the conduct of 
clinical  trials  investigating  the  ATMPs,  the  authorisation  procedure  should  be 
shortened by removing the additional 50 days of assessment period which is currently 
applicable 

(130)  Furthermore,  to  leverage  the  mutual  trust  and  foster  the  high  ethical  standards,  the 
ethics committees should be involved in the assessment of ethical aspects of Part I of 
the application dossier. This ethical perspective should be integrated in the assessment 
report  by  the  reporting  Member  State.  Member  States  concerned  should  be  able  to 
raise,  where  relevant,  consolidated  considerations  integrating  inputs  from  their 
responsible  ethics  committees.  The  mandatory  integration  of  ethical  review  in  Part  I 
assessment  by  the  reporting  Member  State  would  ensure  that  the  ethical  review  is 
conducted in a more harmonised and transparent manner. Such integration should also 
result  in  fewer  and  more  consistent  considerations  and  therefore  support  overall 
robustness  of  the  evaluation  with  decreased  burden  for  sponsors  and  national 
regulatory bodies.  

(131)  It is appropriate that an enhanced EU portal provides technical means for a clear and 
timely  communication  between  the  involved  Member  States  and  the  sponsor  during 
the assessment, when requests for information are issued.  

(132)  To  increase  further  the  efficiency  and  speed  of  Part  I  assessments  in  multinational 
clinical  trials,  when  translations  of  Part  I  documents  are  required  by  national  law, 
these  should  be  assessed  with  the  Part  II.  Considerations  regarding  the  accuracy  of 

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these translations will be raised by the Member States concerned with the sponsor in 
the Part II assessment process. Moving the assessment of translation quality into Part 
II of the application will allow the reporting Member State to  focus on the technical 
and  scientific  assessment  of  the  trial,  while  Member  States  concerned  would  retain 
their ability to verify the linguistic accuracy and suitability for their territories.  

(133)  To ensure that the sponsor of clinical trials can adapt them dynamically through their 
life  cycle  to  changed  circumstances  or  to  consider  the  scientific  developments  and 
ensure  smooth  conduct  of  the  clinical  trial,  a  submission  of  parallel  substantial 
modification  should  be  allowed.  Such  submissions  should  be  allowed  when  the 
substantial modification, despite an ongoing approval of another one, concerns distinct 
and  independent  aspects  of  the  dossier.  Allowing  parallel  substantial  modifications 
would  support  increased  flexibility  and  responsiveness  of  the  regulatory  system.  It 
would  facilitate  updates  related  to  subjects'  safety  and  enable  timely  response  to 
emerging  scientific  knowledge  or  allow  operational  adaptations  to  improve  patients 
access and trial efficiency.  

(134)  To  further  support  the  efficiency  and  consistency  of  clinical  trial  submissions  across 
the  Member  States,  it  is  appropriate  to  develop  and  oblige  the  use  of  harmonised 
templates for the submission of Part II documents of clinical trial applications. The use 
of  harmonised  templates  is  expected  to  simplify  the  application  and  assessment 
processes  reducing  administrative  burden  both  for  sponsors  and  Member  States. 
Harmonised  templates  may  be  updated  in  the  light  of  technical  and  scientific 
evolution. Member States concerned may choose to rely also on the assessment of the 
reporting Member State of common aspects and elements in Part II application further 
streamlining initial authorisation and for additional efficiency gains. 

(135)  Innovative  and  personalised  therapies  often  combine  the  use  of  medicinal  products 
with  medical  devices,  including  in  vitro  diagnostic  medical  devices.  During  the 
development of such therapies, clinical trials of one or more medicinal products may 
need  to  be  combined  with  clinical  investigation  of  one  or  more  medical  devices  or 
performance  studies  of  one  or  more  in-vitro  diagnostic  medical  devices.  The 
authorisation and conduct of such combined studies are complex due to the application 
of requirements of two or three Union legislative frameworks in the area of health and 
the  fact  that  these  are  typically  conducted  across  several  Member  States.  In  order  to 
support innovation and make efficient use of sponsors’ and Member States’ resources, 
it is necessary to put in place a dedicated pathway for the authorisation and conduct of 
such combined studies, involving coordinated assessment across Member States.  

(136)  The  experience  gained  during  the  Covid-19  pandemic  has  shown  the  need  for  the 
Union to swiftly take up measures to strengthen the development and access to crisis-
relevant medicines, including to accelerate, simplify, and streamline the authorisation 
of multinational clinical trials relevant to prevent, treat or diagnose the disease caused 
by an emerging serious cross-border threat to health. Regulatory flexibility, including 
an  accelerated  authorisation  procedure  for  clinical  trials,  is  necessary  to  address  and 
possibly  contain  an  emerging  health  threat  in  a  timely,  efficient  and  coordinated 
manner.  Therefore,  it  is  appropriate  to  allow  for  an  accelerated  procedure  for  the 
authorisation  of  multinational  clinical  trials  in situations  where  a  public  health 
emergency  at  Union  level  has  been  recognised  in  accordance  with  Article  23(1)  of 

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Regulation  (EU)  2022/2371  of  the  European  Parliament  and  of  the  Council54,  or  in  
situations of an emerging serious cross-border threat to health that is likely to lead to 
the  recognition  of  a  public  health  emergency  at  Union  level.  This  should  also 
complement  measures  from  the  Regulation  (EU)  2022/2372  of  the  Council55  on  a 
framework  of  measures  for  ensuring 
the  supply  of  crisis-relevant  medical 
countermeasures in the event of a public health emergency at Union level.   

(137)  Based  on  the  experiences  gained  from  the  application  of  Regulation  (EU)  No 
536/2014, it is appropriate to further tailor the requirements for the authorisation and 
oversight  of  clinical  trials  according  to  the  risks  they  pose  to  the  subjects.  In  this 
context,  the  risk  categorisation  scheme  should  be  further  refined  by  differentiating 
between minimal-intervention clinical  trials that present  post-marketing authorisation 
trials  and  low-intervention  clinical  trials  that  use  authorised  medicinal  products  with 
proven scientific evidence on the efficacy and safety but are used outside their initial 
marketing authorisation. 

(138)  Clinical trials that meet the criteria for minimal-intervention clinical trials should only 
require an  ethical review before the clinical trial can begin. An enhanced application 
of  a  risk-proportionate  approach  will  contribute  to  fostering  a  regulatory  framework 
that  is  conducive  to  research  and  innovation.  Sponsors,  particularly  non-commercial 
ones who conduct  the majority  of minimal-intervention and low-intervention  clinical 
trials  in  the  Union,  will  greatly  benefit  from  simplified  and  risk-proportionate 
regulatory  requirements 
through  a  reduced  administrative  burden,  while  not 
compromising  subjects’  safety,  well-being,  and  rights.  A  reinforced  application  of  a 
risk-proportionate regulatory framework further allows Member States to  concentrate 
on their assessment on clinicals trials associated with greater risk to the subjects. 

(139)  To  ensure  that  clinical  trials  accurately  represent  the  target  population  in  all  its 
diversity,  and  to  enhance  the  treatments  available  for  vulnerable  populations,  
medicinal products which are likely to offer significant clinical benefit should be fully 
and appropriately studied for their effects in these specific groups, including as regards 
requirements  related  to  their  specific  characteristics  and  the  protection  of  the  health 
and  well-being  of  subjects  belonging  to  these  groups.  The  protection  of  vulnerable 
populations,  in  this  context,  such  as  incapacitated  subjects,  minors  and  pregnant  or 
breastfeeding women, requires a proper consideration of the risks of exclusion against 
risks of inclusion in clinical trials. This is in accordance with the 2024 version of the 
World Medical Association's Declaration of Helsinki. 

(140)  Electronic  health  data  accessed  under  Chapter  IV  of  Regulation  (EU)  2025/327  can 
offer  valuable  insights  for  clinical  trials,  particularly  regarding  the  protocol  or  the 
investigational medicinal products dossier design. Therefore, sponsors should be able 
to  utilize  this  data  when  applying  for  clinical  trial  authorisation  or  modifications. 
Additionally, competent authorities should consider this data during the assessment of 
such applications.  

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55 

Regulation (EU) 2022/2371 of  the European Parliament and of the Council of 23 November 2022 on 
serious cross-border threats to health and repealing Decision No 1082/2013/EU  (OJ L 314, 6.12.2022, 
ELI: http://data.europa.eu/eli/reg/2022/2371/oj) 
Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the 
supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union 
level. 

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(141)  The development of a medicinal product may require various clinical trials until robust 
data  regarding  its  safety  and  efficacy  are  available  to  support  the  submission  of  a 
marketing authorisation application. The knowledge of the products is built gradually 
during  this  development.  Using  the  same  dossier  for  an  investigational  medicinal 
product  in  different  clinical  trials  helps  to  ensure  the  collection  of  consistent  and 
complete information, streamlines product development, supports efficient assessment, 
management and oversight, and can speed up the time to the market. For this reason, a 
sponsor  should  be  able  to  request  the  establishment  of  an  investigational  medicinal 
product  core  dossier  and  rely  on  this  dossier  by  referencing  it  in  all  clinical  trials 
related  to  the  investigational  product  concerned.  In  order  to  keep  the  core  dossier 
updated,  sponsors  should  be  able  to  request  its  modification.  One  of  the  Member 
States  concerned  by  the  trials  with  investigational  medicinal  product  should  assume 
the role of core dossier depositary Member State and take responsibility for verifying 
completeness  and  suitability  of  the  core  dossier  and  managing  the  requests  for  its 
updates. Member  States  concerned  in  the  core  dossier  should  rely  on  the  assessment 
by  the  depositary  Member  State.  The  depositary  Member  State  may  consult  the 
Member States concerned as appropriate.  

(142)  In the development of biosimilar medicinal products, the rapid evolution of analytical 
and  functional  characterisation  methods  for  complex  biological  and  biotechnological 
active  substances  calls  for  tailored  clinical  approach  in  biosimilar  development  with 
reduced  need  for  confirmatory  comparative  clinical  efficacy  trials. Submission  of  a 
simplified investigational medicinal product dossier (IMPD) for biosimilar medicines 
to  replace,  as  appropriate  quality  and  quality  control  data,  with  a  reference  to  the 
relevant  additional  quality  substance  master  file  or  corresponding  certificates  would 
complement the shift in more risk proportionate clinical data requirements. This dual 
simplification  and  streamlining  should  focus  on  the  regulatory  scrutiny  of  key 
comparability  data  rather  than  require  duplicative  submission  and  assessment  of  the 
full IMPD quality dossier. Combining streamlined and robust quality data assessment 
with  targeted  clinical  data  generation  should  support  an  integrated  and  efficient 
development  pathway  for  biosimilars  with  reduced  administrative  burden  and 
development  costs  for  biosimilar  manufacturers,  in  particular  in  the  Union. 
Accelerated  access  to  biosimilar  medicines  to  the  market  should  support  patients' 
access to more affordable biological therapies.  

(143)  To further optimise the use of resources for both the sponsors and Member States, the 
possibility to refer, in a clinical trial application, to an active substance master file or a 
corresponding certificate, or a certificate confirming that the quality of the substance is 
suitably  controlled  by  the  relevant  monograph  of  the  European  Pharmacopeia,  or  a 
certified  platform  technology  master  file  should  be  available  as  appropriate  for  any 
investigational medicinal product, including for ATMPs. In these cases, the simplified 
IMPD  must  contain  all  relevant  data  to  the  active  substance  or  its  manufacturing, 
which is not covered in the referenced master file or certificate.  

(144)  To address the increased significance of delivery of investigational medicinal products 
and auxiliary medicinal products to subjects, Regulation (EU) No 536/2014 should be 
amended to provide a framework for the controlled transport within a Member State, 
where  the  clinical  trials  have  been  authorised,  of  such  products  directly  to  subjects' 
residences  or  through  a  dispensing  pharmacy  or  by  an  authorised  person,  under  the 
investigator's  oversight.  This  ensures  responsible  and  transparent  delivery  practices 
and  adapts  to  the  real  word  necessities,  as  demonstrated  during  the  COVID  19 

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pandemic. Distribution  through  a  dispensing  pharmacy  or  by  an  authorised  person 
could be considered in particular in cluster trials.  

(145)  To  enhance  regulatory  efficiency,  to  ensure  consistency  in  the  implementation  of  
Regulation  (EU)  No  536/2014  across  the  Union,  and  to  facilitate  predictability  of 
requirements  for  the  developers  of  medicinal  products,  it  is  necessary  to  provide  a 
framework for the harmonisation of national requirements regarding the distribution of 
investigational  and  auxiliary  medicinal  products,  notably  for  decentralised  and 
multinational  clinical  trials.  To  achieve  such  harmonisation,  the  inspection  working 
groups, which provide input and recommendations on all matters relating, directly or 
indirectly,  to  good  clinical  practice,  good  manufacturing  practice,  and  good 
distribution practice should draw up guidelines, in collaboration with the Commission, 
and revise them as necessary to reflect technical and scientific progress in the field of 
clinical  trials.  In  consideration  of  the  specialised  knowledge  and  experience  of  its 
members,  who  represent  the  Member  States,  the  inspection  working  groups  are 
particularly  well-suited  to  facilitate  the  coordination  of  national  requirements, 
eliminate  unnecessary  administrative  obstacles,  and  promote  a  more  efficient  and 
harmonised approach to the conduct of clinical trials within the Union. 

(146)  To facilitate the implementation of Regulation (EU) No 536/2014, while at the same 
time  preserving  the  protection  of  quality  of  investigational  medicinal  products  and 
ensuring  greater  predictability  for  sponsors,  it  is  also  appropriate  to  provide  the 
general  principles  on  how  to  ensure  quality  in  the  processes  not  subject  to  a 
manufacturing and import authorisation, such as re-packaging and re-labelling.   

(147)  Verification  of  compliance  with  the  legal  requirements  of  manufacturing  of 
investigational  medicinal  products  by  relevant  entities 
through  a  system  of 
supervision,  is  of  fundamental  importance  to  ensure  that  the  objectives  of  this 
Regulation are effectively achieved. The provisions of Directive (EU) …/… [reference 
to be added after adoption cf. COM(2023) 192 final] regarding the supervision system 
and the cooperation on inspections, and provisions of [Regulation  (EU)  …/…  of the 
European  Parliament  and  the  Council  [reference  to  be  added  after  adoption  cf. 
COM(2023)  193  final]  regarding  the  cooperation  between  national  competent 
authorities  and  the  Agency  for  inspections  in  third  countries  should  apply  to  the 
supervisions of manufacturing of investigational medicinal products.   

(148)  Verification  of  compliance  with  the  provisions  of  Regulation  (EU)  No  536/2014, 
including for verification of compliance with good clinical practices, through a system 
of  supervision,  is  of  fundamental  importance  to  ensure  that  the  objectives  of  this 
Regulation  are  effectively  achieved.  Therefore,  the  competent  authorities  of  the 
Member  States  should  have  the  power  to  perform  on  site  or  remote  inspections, 
including  unannounced  inspections,  where  necessary.  Where  needed,  the  competent 
authority  of  a  Member  State  should  also  be  able  to  request  support  from  another 
Member State or the Agency to carry out  a joint  inspection, or to  request  a Member 
State or the Agency to carry out the inspection on their behalf.  

(149)  The disruptive and innovative approaches to clinical trials may require adaptations to 
the rules governing clinical trial approvals and conduct. To harness the benefits of this 
innovation while providing necessary safeguards, it is essential to create a safe space 
for  testing  new  regulatory  approaches  and  technologies.  This  includes,  where 
appropriate,  the  use  of  AI  in  trial  design,  data  collection,  analysis,  and  participant 
interaction. For that reason, it is necessary to provide for a possibility of setting up a 
controlled  experimental  environment  in  the  form  of  a  regulatory  sandbox,  allowing 

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regulators  to  test  new  methods  for  authorising  and  conducting  clinical  trials,  for 
example, when some requirements of the dossier cannot be fully complied with, while 
ensuring  strong  safeguards  for  participant  protection  and  data  robustness.  Insights 
gained from sandbox activities should inform future guidance and, where appropriate, 
legislative amendments.  

(150)  The processing of personal  data under Regulation (EU) No 536/2014  should  comply 
with  the  requirements  for  the  protection  of  personal  data,  including  genetic  data  and 
data  concerning  health,  laid  down  in  Regulations  (EU)  2016/67956 and  (EU) 
2018/172557 of the European Parliament and of the Council. It is appropriate to clarify 
that the basis for the processing of personal data in the context of clinical trials is laid 
down  in  Regulation  (EU)No  536/2014,  pursuant  to  Article  6(1),  point  (c),  of 
Regulation (EU) 2016/679. The Agency should have access to personal data necessary 
to  perform  its  tasks  in  the  public  interest  or  complying  with  legal  obligations  in 
accordance  with  Articles  40,  80  and  81  of  Regulation  (EU)  No  536/2014.  The 
Commission should have access to personal data necessary for it to perform its task in 
accordance with Articles 78, 79, 80, 81, of  Regulation (EU) No 536/2014. 

(151)  In  particular,  Regulation  (EU)  No  536/2014  should  be  amended  torequire  the 
processing of personal data by the sponsors and investigators where this is necessary 
to comply with the legal obligations imposed on them to ensure the safety and efficacy 
of medicinal products, when they request authorisation for and conduct clinical trials. 
This  includes  obligations  to  perform  research  activities  in  accordance  with  an 
authorised  protocol,  to  perform  safety  reporting,  and  to  perform  archiving  in 
accordance  with  Regulation  (EU)  No  536/2014.  The  relevant  information  to  be 
collected  according  to  the  authorised  protocol  will  contain  personal  data  of  the 
subjects,  including  genetic  data  or  data  concerning  health.  The  processing  of  such 
special  categories  of  personal  data  in  the  context  of  clinical  trials  takes  place  for 
reasons  of public interest  in  the area of public health,  in  particular for ensuring high 
standards  of  medicinal  products  in  compliance  with  Article  9(2),  point  (i),  of 
Regulation (EU) 2016/679. Additionally, personal data may encompass identification 
details,  such  as  sex  and  age,  social  insurance  numbers  and  contact  information. 
Moreover, sponsors may collect and process other data necessary for implementing the 
authorised  protocol,  such  as  the  personal  data  of  investigators.  The  categories  of 
personal  data  to  be  collected  and  processed  in  the  context  of  a  specific  clinical  trial 
should be specified in  the authorised protocol.  Regulation  (EU) No 536/2014 should 
be  amended  to  establish  specific  safeguards  for  the  processing  of  personal  data, 
including  genetic  data  or  data  concerning  health,  in  compliance  with  Article  9(2), 
points  (i)  and  (j),  of  Regulation  (EU)  2016/679.  For  instance,  it  should  require 
informed  consent  to  participate  in  the  clinical  trial,  as  well  as  to  maintain 
confidentiality  of  records  and  personal  data  of  participants.  The  protocol  should 
specify  further  appropriate  safeguards  such  as  specific  technical  and  organisational 

56 

57 

Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, 
p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj). 
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
39,  ELI: 
and  Decision  No 
45/2001 
http://data.europa.eu/eli/reg/2018/1725/oj). 

1247/2002/EC 

21.11.2018, 

(OJ  L 

295, 

p. 

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measures  that  should  be  employed,  including  pseudonymisation,  integrity  and 
confidentiality  controls,  encryption  and  access  restrictions.   In  addition,  any  clinical 
trial should be subject to ethical review. 

(152)  Since this Regulation amends Regulation (EU) No 536/2014 to establish a harmonised 
framework for the processing of personal data in the context of clinical trials, Member 
States  should  not  be  able  to  maintain  or  introduce  under  Article 9(4)  of  Regulation 
(EU)  2016/679  further  conditions,  including  limitations  and  specific  provisions  such 
as  requesting  the  consent  of  natural  persons  in  the  sense  of  that  Regulation,  with 
regard  to  the  processing  of  personal  data,  including  genetic  data  or  data  concerning 
health under Regulation (EU) No 536/2014 as amended by this Regulation.  

(153)  Personal  data  which  is  collected  and  processed  under  each  authorised  protocol  in 
accordance with Regulation (EU) No 536/2014 as amended by this Regulation may be 
further  processed  by  the  same  controller  for  the  purposes  of  other  clinical  trials, 
conducted in accordance with Regulation (EU) No 536/2014. Such data may include 
names, contact details, health and genetic data of subjects. It should also be possible to 
further  process  such  personal  data  by  the  same  controller  for  scientific  research 
purposes.  

(154)  To further address the issue of fragmentation within and across Member States on the 
application of the measures applicable to the conduct of clinical trials and, as regards 
certain aspect that remain national, and drive further harmonisation, it is necessary to 
enable  closer  cooperation  between  and  across  Member  States’  competent  authorities 
and  ethics  committees.  For  that  purpose,  the  role  and  tasks  of  the  Clinical  Trials 
Coordination and Advisory Group (CTAG) should be extended. The CTAG should in 
particular  be  empowered  to  issue  or  endorse  guidance  documents  related  to  clinical 
trials  conduct  and  supervision,  to  ensure  uniform  interpretation  and  harmonised 
implementation of Regulation (EU) No 536/2014 across the Member States.  

(155)  Ethics  committees  involved  in  the  assessment  of  clinical  trials  application  should 
collaborate  in  a  dedicated  forum  with  the  objective  to  strengthen  cooperation  in  the 
area of ethical aspects of clinical trials which are of national competence.  

(156)  Regulation  (EU)  No  536/2014  outlines  the  responsibilities  of  Member  States  in 
designating  competent  authorities  and  ethics  committees  for  regulatory  activities, 
including  oversight.  To  perform  their  roles  as  required  by  the  provisions  of  this  
Regulation amending Regulation (EU) No 536/2014, these competent authorities and 
responsible ethics committees should be vested in the necessary powers, have at their 
disposal  qualified  personnel  and  sufficient  resources  to  perform  their  duties 
effectively.  Regulation (EU) 536/2014  emphasizes the importance of communication 
and coordination to ensure consistent and efficient regulatory actions within Member 
States.  It  is  also  essential  to  define  how  the  Commission  will  verify  the  correct 
implementation of the law by the competent authorities. Regulation (EU) No 536/2014 
should be amended accordingly. 

(157)  The  integration  of  AI  in  clinical  trials  presents  opportunities  to  enhance  the  clinical 
trials’  design,  execution,  and  oversight.  This  technological  advancement  offers 
substantial  benefits  to  clinical  trial  sponsors,  regulators,  and  ultimately  patients. 
Among  the  possible  enhancements  are  improved  endpoint  determination,  advanced 
statistical  analysis,  optimized  patient  selection,  enhanced  data  handling  and  analysis. 
While  AI  tools  aim  to  accelerate  the  development  of  medicinal  products,  it  is 
imperative  that  their  use  in  clinical  trials  adheres  to  applicable  legislation.  This 

EN 

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includes,  when  applicable,  compliance  with  Regulation  (EU)  2024/1689,  Regulation 
(EU) 2017/746, Regulation (EU) 2017/745 and Regulation (EU) 2016/679. 

(158)  Sponsors hold the responsibility to evaluate the potential impact and risk of AI tools 
on  patient  safety  based  on  guidelines.  Untested  systems  may  introduce  gender  and 
other biases and errors, risking unreliable outcomes or failures in interpreting medical 
data  accurately.  Such  risks  could  lead  to  misdiagnosis,  incorrect  treatment,  or 
inaccurate  patient  selection,  especially  hazardous  in  extensive  clinical  trials  with 
numerous  participants.  The  guidelines  on  the  developments  and  deployment  of  AI 
tools  developed  by  the  Agency,  in  cooperation  with  the  Clinical  Trials Coordination 
and  Advisory  Group,  and  as  appropriate,  with  other  expert  groups  established  under 
Union  law,  should  assist  the  sponsors,  national  competent  authorities  and  ethics 
committees in assessment of AI tools benefits and risks in the context of the lifecycle 
of clinical trials.  

(159)  To further strengthen the competitiveness of the European Union in clinical research 
and ensure timely access of patients to innovative medicines, it is necessary to monitor 
the  effectiveness  of  the  provisions  in  thisRegulation  amending  Regulation  (EU)  No 
536/2014  to  streamline  and  simplify  the  authorisation  and  conduct  of  multinational 
clinical trials. Such monitoring should be based on key performance indicators such as 
the increase in the number of clinical trials in the Union over the period of five years, 
as  this  indicator  reflects  both  the  attractiveness  of  the  Union  and  the  capacity  of  the 
European  regulatory  system  to  support  clinical  research  with  maintained  high  data 
quality  and  patients’  safety  standards.  Regulation  (EU)  No  536/2014  should  be 
amended accordingly.  

(160)  The management of changes through the lifecycle of veterinary medicinal products is 
subject  to  regulatory approvals.  The handling of  variations  for biological  products  is 
particularly  critical because of the impact that changes in the source materials or the 
manufacturing  process  can  have  on  the  safety  and  efficacy  attributes  of  the  finished 
product.  It  is  necessary  to  continue  ensuring  that  changes  introduced  during  the 
lifecycle of a veterinary medicinal do not alter the positive benefit-risk balance while 
the  process  for 
avoiding  unnecessary  administrative  burden.  To 
implementation  of  variations  not  requiring  assessment  laid  down  in  Article  61  of 
Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council58  should  be 
further optimised.  

this  end, 

(161)  Advances in biotechnology bring new opportunities for the development of veterinary 
medicinal products, including the possibility to develop vaccines with improved safety 
and efficacy profiles  in  a much shorter timeframe. The possibility to  deploy  and use 
vaccines  quickly  is  essential  to  react  to  outbreaks  of  certain  animal  diseases  thereby 
reducing  the  risks  for  human  health,  contributing  to  animal  welfare  and  reducing 
economic losses for farmers.  

(162)  Safety  for  veterinary  medicinal  products  is  assessed  during  marketing  authorisation 
procedures  in  accordance  with  Regulation  (EU)  2019/6.  The  competent  authorities 
responsible  for  the  granting  of  marketing  authorisations  are  required  to  verify  the 
safety  for  the  target  species,  for  the  user,  for  consumers  and  for  the  environment. 
Likewise,  the  conduct  of  clinical  trials  is  subject  to  the  approval  and  supervision  by 

58 

Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  of  11  December  2018  on 
veterinary  medicinal  products  and  repealing  Directive  2001/82/EC  (OJ  L  4,  7.1.2019,  p.  2,  ELI: 
http://data.europa.eu/eli/reg/2019/6/oj). 

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competent authorities responsible for veterinary medicinal products. Regulation (EU) 
2019/6 further requires that such trials are conducted in accordance with Good Clinical 
Practice,  which  includes  the  obligation  for  sponsors  to  ensure  that  there  are  no 
environmental grounds precluding the conduct of the trial.  

(163)  Regulation (EU) 2019/6 and the Union GMO legislation (Directives 2001/18/EC59 and 
2009/41/EC60,  Regulations  (EC)  1829/200361,  1830/200362  and  1946/200363  of  the 
European Parliament and of the Council share the same protection goals as regards the 
protection of human and animal health and the environment from genetically modified 
organisms. Since parallel assessments and documentation and increased administrative 
burden  is  not  conducive  to  increased  protection  of  human  health  or  the  environment 
and has negative effects on the use of biotechnology in veterinary medicine, the risks 
for  human  and  animal  health  and  to  the  environment  from  veterinary  medicinal 
products containing or consisting of genetically modified organisms should be solely 
assessed  in  accordance  with  Regulation  (EU)  2019/6.  This  simplification  should  be 
coupled with a reinforcement of existing obligations as regards the conduct of clinical 
trials with veterinary medicinal products that contain or consists of GMOs.  

(164)  To remove any legal uncertainty for developers, marketing authorisation holders and 
users,  it  should  also  be  clarified  that  given  the  purpose  of  veterinary  medicinal 
products  to  treat  animals,  their  administration  does  not  bring  the  treated  animals  or 
their products under the scope of the Union GMO legislation.  

(165)  The Commission should be empowered to adopt delegated acts to amend Annex II to 
Regulation (EU) 2019/6 in order to adapt it to scientific and technical progress.  

(166)  Veterinary  medicinal  products  developed  by  means  of  biotechnology  processes  to 
diagnose,  treat  or  prevent  zoonotic  diseases  should  be  entitled  to  an  extra  year  of 
supplementary protection certificate (‘SPC’) in order to support their development. 

(167)  Scientific  and  technical  progress  in  biotechnology  enables  the  development  of  new 
technologies, methods or products that may not fit into existing Union legislation. The 
lack of harmonised requirements is an impediment to the development, marketing and 
use of new concepts that may, however, bring benefit to animal healthcare. Regulatory 
sandboxes may be established to facilitate the development, placing on the market or 
use of innovative technologies, methods or products related to animal health which are 
directly  or  indirectly  related  to  the  development,  manufacturing  or  use  of  veterinary 
medicinal products under conditions that ensure protection of animal and public health 
as well as the environment. A regulatory sandbox should only be established if there is 
no  Union  legislation  governing  the  marketing  and  use  of  the  relevant  technology, 
method or product. 

59 

60 

61 

62 

63 

Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). 
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained 
use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75,). 
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). 
[Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the  Council  of  22  September 
2003on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). 
Regulation  (EC)  No  1946/2003  of  the  European  Parliament  and  of  the  Council  of  15  July  2003  on 
transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p.1). 

EN 

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(168)  A  regulatory  sandbox  may  be  established  by  the  Commission,  by  way  of  an 
implementing  act  following  a  recommendation  of  the  Agency  which  should  analyse 
expected  potential  benefits  and  risks  as  well  as  existing  regulatory  challenges. 
Technical and scientific requirements for the technologies, methods or products under 
the  regulatory  sandbox  and  procedures  should  be  developed  and  published  by  the 
Agency. The Agency should ensure that the requirements and procedures it develops 
are proportionate and are adapted to the specific risks. A regulatory sandbox may be 
terminated  at  any  time  where,  following  the  identification  of  negative  impacts  on 
animal or public health or the environment, the benefit-risk balance becomes negative 
and there are no satisfactory risk mitigation measures that could be implemented. 

(169)  Technologies, methods or products developed under a regulatory sandbox should only 
be  placed  on  the  market  or  used  on  the  basis  of  an  authorisation  granted  by  the 
Commission.  Depending  on the specific characteristics  of the products  concerned,  a 
class  authorisation  to  market  or  use  technologies,  methods  or  products  may  be 
possible. Member States should be empowered to take interim measures where serious 
risks  to  animal  or  public  health  or  the  environment  are  identified.    In  such  cases, 
Member States should swiftly inform the Agency.  

(170)  To ensure legal certainty, the termination of a regulatory sandbox should not affect the 
validity of the authorisations  to  place on the market  or use  technologies,  methods or 
products  already  granted,  unless  the  regulatory  sandbox  has  been  terminated  on 
grounds related to the protection of public or animal health or the environment. 

(171)  To  provide  legal  certainty  to  developers  and  competent  authorities  alike,  time  limits 
should  be  established  also  in  the  Regulation  (EU)  2024/1938  and  for  all  actors 
involved in the consultation process, at national and Union level, including the SoHO 
competent  authorities,  the  Substances  of  Human  Origin  Coordination  Board  (‘the 
SCB’),  established  in  that  Regulation  and  advisory  bodies  established  under  other 
relevant  Union  legislation.  Consequently,  Regulation  (EU)  2024/1938  should  be 
amended  to  provide  the  power  for  the  Commission  to  adopt  implementing  acts  to 
establish  such  time  limits,  that  should  be  ambitious  and  determined  based  on 
experience  gathered  with  the  consultation  process  as  of  the  entry  into  application  of 
that Regulation. 

(172)  The  field  of  substances  of  human  origin  is  characterised  by  rapid  scientific  and 
technological  innovation,  giving  rise  to  health  biotechnology  approaches  that  may 
present  scientific  or  regulatory  challenges  under  existing  legal  requirements.  To 
support the development of such innovations at early stages while maintaining public 
health protection, Member States should be able to establish regulatory sandboxes for 
substances of human origin that cannot yet be developed in full compliance with the 
requirements  of  Regulation 
innovative 
characteristics  or  methods  are  expected  to  contribute  distinctively  to  quality,  safety, 
effectiveness,  or  patient  access  to  treatment.  The  sandbox  activities  should  enable  a 
discussion on the development of common approaches and the potential adaptation of 
legislative  frameworks  based  on  accumulated  experience.  Any  substances  of  human 
origin developed through regulatory sandboxes should only be distributed for human 
application  when  properly  authorised,  with  initial  authorisations  limited  to  the 
regulatory 
controlled 
experimentation with innovative regulatory approaches while preserving the essential 
safeguards  for  public  health  and  safety.  Regulation  (EU)2024/1938  should  be 
amended accordingly.  

(EU)  2024/1938,  provided 

sandbox  duration.  This 

framework 

should 

enable 

that 

the 

EN 

69 

  EN 

 
(173)  The  regulatory  sandboxes  in  the  field  of  substances  of  human  origin  should  be 
conducted  under  the  supervision  of  the  concerned  SoHO  competent  authorities,  and, 
where relevant, competent authorities under other Union and Member State legislation 
concerned.  The  latter  authorities  should  be  in  particular  involved  where  the 
preparation of the SoHO requires steps using products regulated under another Union 
legislative framework, or where SoHO is presented as a therapy together with products 
regulated under another such Union framework. 

(174)  In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation 
regarding the recognition  by the Commission  of high  impact  biotechnology strategic 
projects,  the  modalities  for  the  processing  of  personal  data  necessary  to  achieve  the 
purpose of such projects in the form of biotechnology data quality accelerators and the 
rules  for  the  selection,  composition,  number  of  members,  and  functioning  of  the 
Foresight  Panel  for  Emerging  Health  Innovation,  implementing  powers  should  be 
conferred on the Commission. 

(175)  In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing power should  be conferred on the  Commission to  detail  the criteria to 
clarify in what cases a project is to be deemed to have a strong systemic and catalytic 
potential within the Union’s biotechnology ecosystem and accelerate innovation, detail 
the  criteria  for  the  recognition  of  centres  of  excellence  for  advanced  therapies, 
including  advanced  therapy  medicinal  product,  establish  procedural  rules  for  the 
recognition  of  high  impact  health  biotechnology  strategic  projects  and  the  format  of 
the  assessment  report  to  be  submitted  by  the  designated  authorities  in  relation  to 
applications  for  recognition  of  high  impact  health  biotechnology  strategic  projects, 
establish  regulatory  sandboxes  for  health  biotechnology  products  and  common 
principles,  criteria  and  practical  arrangements  for  the  assessment  of  applications 
received from developers and for the establishment and supervision of the regulatory 
sandboxes and related sandbox plans. Those powers should be exercised in accordance 
with Regulation (EU) No 182/2011. 

(176)  The  power  to  adopt  acts  in  accordance  with  Article  290  of  the  Treaty  on  the 
Functioning of the European Union should be delegated to the Commission in respect 
of modifying Annex I to this Regulation listing the biotechnology products of concern. 
It is of particular importance that the Commission carries out appropriate consultations 
during its preparatory work, including at expert level, and that those consultations be 
conducted  in  accordance  with  the  principles  laid  down  in  the  Interinstitutional 
Agreement  on  Better  Law-Making  of  13  April  2016.  In  particular,  to  ensure  equal 
participation  in  the  preparation  of  delegated  acts,  the  European  Parliament  and  the 
Council receive all documents at  the same time as  Member States' experts,  and their 
experts systematically have access to meetings of Commission expert groups dealing 
with the preparation of delegated acts. 

(177)  The  European  Data  Protection  Supervisor  and  the  European  Data  Protection  Board 
were  consulted  in  accordance  with  Article  42  of  Regulation  (EU)  2018/172564  and 
delivered an opinion [date]. 

64 

EN 

Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
39–
45/2001 
98, ELI: http://data.europa.eu/eli/reg/2018/1725/oj) 

and  Decision  No 

1247/2002/EC,  OJ 

21.11.2018, 

295, 

pp. 

L 

70 

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(178)  Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States but can rather, by reason of the scale or effects of the action, be better achieved 
at  Union  level,  the  Union  may  adopt  measures  in  accordance  with  the  principle  of 
subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In  accordance 
with the principle of proportionality as set out in that Article, this Regulation does not 
go beyond what is necessary in order to achieve those objectives. 

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 

SUBJECT MATTER, SCOPE AND DEFINITIONS 

Article 1 

Subject matter and scope  

1. 

This  Regulation  establishes  a  framework  to  strengthen  the  competitiveness  of  the 
health  biotechnology  sector  in  the  Union.  It  creates  and  reinforces  favourable 
conditions  for  health  biotechnology  as  defined  in  Article  2(1),  point  (2),  from 
research and development to the timely placing on the Union market and production 
of  biotechnology  innovations  and  products,  while  safeguarding  high  standards  of 
protection of human health, patient safety and animal health, the environment, ethics, 
quality of products, food and feed safety and biosecurity. 

2. 

This Regulation lays down measures regarding: 

(a) 

the establishment of a framework for the recognition of, and support measures 
for,  health  biotechnology  strategic  projects  and  high 
impact  health 
biotechnology strategic projects; 

(b)  novel  health  biotechnology  products  and  regulatory  sandboxes  to  support 
innovation and take into account technological and scientific developments and 
progress; 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

the support to promoters of biotechnology projects, SMEs, start-ups and scale-
ups  and  non-profit  developers  of  biotechnology  products,  by  establishing  an 
EU Health Biotechnology Support Network; 

the  support  for  funding  of,  investments  in,  and  access  to  capital  for 
biotechnology companies and projects;  

the  enhancement  of  the  manufacturing  capacity  of,  and  expertise  for 
biosimilars in the Union, including through international cooperation; 

the application in a facilitated manner of advanced technologies, including AI 
in  biological  applications,  into  the  Union’s  health  biotechnology  ecosystems, 
while  monitoring  and  mitigating,  in  line  with  the  Union  harmonisation 
legislation on AI, biological risks arising from the use of such technologies;  

the  placing  on  the  market  in  particular  of  health  biotechnology  products  and 
biotechnology services in accelerated and streamlined procedures; 

the  prevention  of  the  misuse  of  biotechnologies  and  the  strengthening  of 
biodefence  capabilities,  without  prejudice  to,  and  in  complementarity  with, 
activities  financed  under  any  defence  related  Union  funding  programmes  and 
instruments. 

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3. 

4. 

5. 

6. 

7. 

This  Regulation  applies  to  health  biotechnology  innovations  and products and their 
ecosystem  during  their  entire  lifecycle,  including  related  research,  funding, 
development,  innovation,  testing,  validation,  manufacturing,  placing  on  the  market, 
and use activities.  

The  amendments  to  the  Union  legislation  laid  down  in  Articles  56  to  61  are  not 
limited  to  health  biotechnology  products  and  activities,  but  also  relate  to  the  other 
products, services and activities that fall in the scope of that legislation.  

This  Regulation  does  not  affect  the  application  of  Directive  2010/63/EU  on  the 
protection of animals used for scientific purposes and of Regulation (EU) 1907/2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH). 

 This Regulation shall apply without prejudice to Regulation (EU) 2024/1689 laying 
down harmonised rules on artificial intelligence. 

This  Regulation  shall  apply  without  prejudice  to  Regulation  […][[Regulation  on 
speeding-up environmental impact assessments -permitting regulation].  

1. 

For the purposes of this Regulation, the following definitions apply:  

Article 2 

Definitions 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

‘biotechnology’  means  the  application  of  science  and  technology  to  living 
organisms, as well as parts, products and models thereof, to alter living or non-
living materials for the production of knowledge, products and services; 

‘health  biotechnology’  means  the  application  of  biotechnology  for  the 
promotion,  protection,  or  restoration  of  human  health  and  biotechnological 
applications  relevant  to  animal  health,  plant  health,  veterinary  public  health, 
and  food  safety,  insofar  as  these  areas  contribute  directly  or  indirectly  to  the 
protection of human health and align with the Union’s public health objectives, 
as set out under Article 168 of the Treaty on the Functioning of the European 
Union; 

‘biotechnology product’ means any good, technology or activity resulting from 
the application of biotechnology, including any process, action, technique, tool 
or knowledge involving biotechnology; 

‘advanced biotechnology innovation’ means a biotechnology product, process, 
service  or  enabling  technology  that  demonstrates,  on  the  basis  of  preliminary 
scientific  or  technical  evidence,  the  potential  to  achieve  a  substantial 
improvement over existing solutions in terms of efficacy, safety, sustainability, 
accessibility,  and/or  cost-effectiveness,  and  that,  by  reason  of  its  novelty, 
technical  complexity  and/or  market-creating  potential,  entails  a  high  level  of 
technological  or  commercial  risk  and  it  is  likely  to  create  new  markets  or 
significantly disrupt existing ones; 

‘biomanufacturing’  means  the  production  of  biotechnology  products  at  a 
commercial scale; 

‘biotechnology  cluster’  means  a  geographic  concentration  of  interconnected 
companies,  research  institutions  and  organisations  focused  on  biotechnology 
and life sciences, fostering collaboration and innovation;  

EN 

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(7) 

(8) 

‘project  promoter’  means  any  undertaking  or  consortium  of  undertakings 
developing a health biotechnology strategic project referred to in Article 3 or a 
high impact health biotechnology strategic project referred to in Article 4; 

‘permit-granting  process’  means  a  process  that  covers  all  relevant  permits  to 
build, expand, convert and operate health biotechnology strategic projects and  
high impact health biotechnology strategic projects, including building permits 
and  environmental  assessments  and  authorisations  where  required,  and 
encompassing all applications and procedures from the acknowledgement that 
the application for such permits is complete to the notification of the decision 
on the outcome of the procedure by the single point of contact concerned; 

(9) 

‘deep  tech’  means  an  innovation  with  the  potential  to  deliver  transformative 
solutions and that is based on cutting-edge advances in science, technology and 
engineering; 

(10)  ‘SME’ means a micro, small or medium-sized enterprise within the meaning of 

the Annex to Commission Recommendation 2003/361/EC65; 

(11)  ‘European  Investment  Bank  Group  (EIBG)’  means  the  European  Investment 
Bank,  the  European  Investment  Fund  or  any  subsidiary  of  the  European 
Investment Bank;  

(12)  ‘national  promotion  bank  or  institution’  means  a  legal  entity  as  defined  in 
Article 2, point (21), of Regulation (EU) 2021/523 of the European Parliament 
and of the Council66; 

(13)  ‘implementing partner’ means an entity implementing, in indirect management, 

support under the EU health biotechnology investment pilot; 

(14)  ‘AI  system’  means  an  AI  system  system  as  defined  in  Article  3(1)  of 

Regulation (EU) 2024/1689;  

(15)  ‘general-purpose  AI  model’  means  an  AI  model  as  defined  in  Article  3point 

(63) of Regulation (EU) 2024/1689;  

(16)  ‘general-purpose AI system’ means a general-purpose AI system as defined in 

Article 3point (66) of Regulation (EU) 2024/1689;  

(17)  ‘clinical  trial’  means  a  clinical  trial  as  defined  in  Article  2(2),  point  (2)  of 

Regulation (EU) No 536/2014; 

(18)  ‘advanced  therapy  medicinal  product’  means  an  advanced  therapy  medicinal 

product as defined in Article 2(1) of Regulation (EC) No 1394/2007; 

(19)   ‘New  Approach  Methodologies  (NAMs)’  means  innovative  methods  that  do 
not  involve  live  animals,  such  as  in  vitro  (cell  or  tissue-based),  in  chemico 
(chemical-based),  or  in  silico  (computer-based)    approaches,  as  well  as 
combinations of these; 

(20)   ‘biological  threats’  means  risks  posed  by  harmful  biological  agents  such  as 
pathogens or toxins that can cause disease or significant societal consequences, 
whether arising naturally, through accidental release, or via deliberate misuse; 

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Commission  Recommendation  of  6  May  2003  concerning  the  definition  of  micro,  small  and  medium-sized  enterprises  (Text  with  EEA  relevance)  (notified 
under document number C(2003) 1422), OJ L 124, 20.5.2003, pp. 36–41. ELI: http://data.europa.eu/eli/reco/2003/361/oj. 
Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation 
(EU) 2015/1017, OJ L 107, 26.3.2021, pp. 30–89. ELI: http://data.europa.eu/eli/reg/2021/523/oj. 

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(21)  ‘biodefence’  means  actions,  policies,  and  measures  that  are  designed,  in 
particular  by  state  actors,  for  preventive,  protective  or  peaceful  purposes,  to 
counter biological threats, reduce risks, and prepare for, detect, assess, respond 
to, and recover from biological threats; 

(22)  ‘biosecurity’  means  the  protection,  control  and  accountability  of  high-
consequence  biological  agents,  technologies,  materials  and  toxins  of  concern, 
as  well  as  of  critical  relevant  information  against  unauthorised  access,  loss, 
theft,  misuse,  diversion  or  intentional  release  by  those  who  intend  to  misuse 
them; 

(23)   ‘biotechnology  product  of  concern’  means  any  good,  service  or  technology, 
including software resulting from the application of science and technology to 
living organisms, their parts, products or models with significant potential for 
biological  misuse  that  are  listed  in  Annex  I,  including  any  thresholds  or 
exclusions;  

(24)  ‘benchtop nucleic acid synthesis equipment’ means any equipment that  allows 
a user to synthesise nucleic acids individually or in a core research facility.   

2. 

For  the  purpose  of  the  provisions  regarding  biosecurity  and  the  prevention  of 
biotechnology misuse laid down in Chapter VIII, Section 2, the following definitions 
apply: 

(a) 

(b) 

(c) 

‘making available’ means any supply, whether in return for payment or free of 
charge; 

“legitimate”  means  in  good  faith,  in  the  ordinary  course  of  recognised 
professional,  research  or  commercial  activities,  and  in  accordance  with 
applicable Union and national law; 

‘legitimate  need’  in  a  biotechnology  product  of  concern  means  the  need  for 
such  biotechnology  for  legitimate  and  peaceful  purposes,  including  handling, 
production,  cultivation,  experimentation,  preservation,  destruction,  internal 
transport, by a legitimate member of the scientific community or a legitimate 
enterprise, consistent with applicable international treaties, laws, standards and 
oversight; 

(d) 

‘suspicious  transaction’  means  any  transaction  concerning  biotechnology 
products  of  concern  for  which  there  are  reasonable  grounds,  taking  into 
account  all  relevant  factors,  to  doubt  the  legitimacy  of  the  prospective 
customer’s intentions.  

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CHAPTER II 

UNION HEALTH BIOTECHNOLOGY AND BIOMANUFACTURING  

SECTION 1 

RECOGNITION OF HEALTH BIOTECHNOLOGY STRATEGIC PROJECTS IN THE UNION  

Article 3 

Health biotechnology strategic projects 

1. 

To  enable  access  to  the  support  measures  laid  down  in  Section  2  of  Chapter  II, 
Member States shall recognise projects located in the Union, by means of a reasoned 
decision,  as  health  biotechnology  strategic  projects  if  they  make  a  substantial 
contribution to at least one of the following specific objectives:  

(a) 

strengthening 
biotechnology sector, through one or more of the following activities: 

industrial  capacity  and  value  chains 

the 

in 

the  health 

(i) 

(ii) 

research  organisations, 
pooling 
biotechnology industry actors and/or public authorities within the Union;  

resources  and  expertise  among 

creating  new,  or  significantly  expanding,  production  facilities  for 
biotechnology  products,  in  particular  in  biotechnology  sectors  where 
such  facilities  do  not  exist  or  where  they  are  limited,  including  for 
biosimilars;  

(iii)  creating  or  upgrading  industrial  scale  biomanufacturing  sites  with 
innovative,  sustainable,  safe  and  digitally  enabled  processes  and 
technologies;  

(iv) 

(v) 

reducing  dependencies on third-country suppliers for key biotechnology 
inputs and intermediates;  

integrating  advanced  digital  and  AI-driven  manufacturing  and  supply-
chain  management  systems  to  enhance  productivity,  traceability  and 
sustainability across biotechnology value chains; 

(b) 

scaling-up  or  upgrading  critical  research  and  technology  infrastructures 
underpinning  the development, testing and validation of  health  biotechnology 
products,  including  but  not  limited  to  pilot  or  testing  infrastructures  for 
biomanufacturing,  data  and  digital  platforms,  through  one  or  more  of  the 
following activities: 

(i) 

establishing,  expanding  or  upgrading  pilot,  testing  and  demonstration 
infrastructures  linking  research,  development,  validation  and  industrial 
deployment capacities for biotechnology products and processes; or 

(ii) 

integrating  advanced  digital,  data  and  AI  capabilities  to  enhance 
modelling, simulation and process optimisation; or 

(iii)  establishing 

interoperable 

infrastructures 

connecting 

research 

organisations, industry and public authorities across the Union; or 

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(iv)  promoting  and  integrating  the  use  of  NAMs  in  areas  such  as  biological 
research,  discovery  and  preclinical  development,  regulatory  and  quality 
testing and production of medicinal products and medical technologies. 

(c) 

accelerating  innovation  and  technology  deployment  in  health  biotechnology 
through one or more of the following activities: 

(i) 

(ii) 

introducing or scaling up breakthrough innovations in biotechnology that 
have  the  potential  to  strengthen  the  Union’s  industrial  competitiveness, 
including AI-enabled technologies and tools; 

supporting  SMEs,  start-ups  and  scale-ups,  universities  and  research 
centres 
laboratory 
capacities; 

in  accessing  advanced  biomanufacturing  and 

(iii)  promoting  technology  transfer  and  collaboration  with  corresponding 
facilities in third countries, where Union-led partnerships are established 
under Union law. 

(d) 

addressing  talent  and  skills  needs  or  preventing  shortages  of  talent  and  skills 
critical  to  all  kinds  of  jobs  in  support  of  the  strengthening  of  the  health 
biotechnology  and  biomanufacturing  sectors,  and  supporting  the  creation  and 
maintenance  of  quality  jobs  in  the  EU  through  one  or  more  of  the  following 
activities: 

(i) 

attracting  and  retaining  talent  in  the  Union  and  aiming  to  provide 
adequate  upskilling  or  reskilling  opportunities  covering  the  broad  range 
of  skills  required  for  biotechnology  and  biomanufacturing,  including 
technical  skills,  data  science,  AI,  intellectual  property  and  project 
management,  and  entrepreneurial  skills,  through  activities  including 
apprenticeships, traineeships, continuing education and training, in close 
cooperation  with  regional  and  local  authorities,  education  and  training 
institutions, businesses and social partners;  

(ii) 

establishing  public-private  partnerships  between  universities,  vocational 
education  and  training  providers,  businesses,  in  particular  SMEs,  start-
ups and scale-ups, social partners and applied research institutes;  

(iii)  establishing  university  alliances,  also  in  cooperation  with  employers,  to 
improve  their  delivery  on  innovation  and  the  development  of  skills  and 
talent. 

(e) 

contributing  to  strengthening  the  EU’s  preparedness  and  response  capacity  to 
priority  health  threats  by  supporting  the  development,  manufacturing  and 
supply of medical countermeasures. 

2. 

The projects referred to in paragraph 1 may be located on the territory of two or more 
Member States.  

Article 4 

High impact health biotechnology strategic projects 

1. 

To  enable  access  to  the  support  measures  laid  down  in  Section  2  of  Chapter  II, 
projects  located  in  the  Union  fulfilling  the  criteria  to  be  recognised  as  health 
biotechnology strategic projects, which demonstrate  by virtue of their scale, scope or 
cross-border relevance, a strong systemic and catalytic potential within the Union’s 

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biotechnology  ecosystem  to  accelerate  innovation  and  enhance  the  translation  of 
research  into  market  applications  shall  be  recognised  by  the  Commission  as  high 
impact health biotechnology strategic projects, including in the following cases:  

(a) 

(b) 

(c) 

(d) 

(e) 

the  project  is  a  biotechnology  development  accelerator  that  fulfils  the 
conditions laid down in Article 5; 

the  project  is  a  centre  of  excellence  for  advanced  therapies,  including  for 
advanced  therapy  medicinal  products  that  fulfils  the  conditions  laid  down  in 
Article 6; 

the project contributes to an EU biotechnology late-stage capital booster pilot, 
fulfilling the conditions laid down in Article 23;  

the project  contributes  to  the development  of trusted testing  environments for 
advanced  biotechnology  innovations,  fulfilling  the  conditions  laid  down  in 
Article 32(1) or is a health biotechnology data quality accelerator, fulfilling the 
conditions laid down in Article 33. 

the project contributes to the EU Biothreat Radar fulfilling the conditions laid 
down  in  Article  41(1)  or  it  is  a  biodefence  capability  high  impact  strategic 
project fulfilling the conditions laid down in Article  42(1).  

The  Commission  may  adopt  implementing  acts  to  detail  the  conditions  set  out  in 
paragraph  1,  to  clarify  in  which  cases  a  project  is  to  be  deemed  to  have  a  strong 
systemic  and  catalytic  potential  within  the  Union’s  biotechnology  ecosystem  to  
into  market 
the 
accelerate 
applications.  These  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 65(2). 

innovation  and  enhance 

translation  of  research 

Article 5 

Biotechnology development accelerators 

To enable access to the support measures laid down in  Section 2 of Chapter II, the 
Commission  shall  recognise  projects  located  in  the  Union  as  high  impact  health 
biotechnology  strategic  projects  in  the  form  of  biotechnology  development 
accelerators, only where they comply with the conditions laid down in Article 4(1), 
and they fulfil at least three of the following conditions: 

(a) 

(b) 

(c) 

provide  trusted  testing  or  demonstration  facilities  replicating  real-world 
biomanufacturing  processes,  including  good  manufacturing  practices  (GMPs) 
compliant  processes,  or  their  enabling  technologies,  for  process  testing, 
validation,  and  small  batch  manufacturing,  including  for  the  investigational 
medicinal products for early stages of clinical trials; such enabling technologies 
may  include  digital  technologies,  with  specific  applicability  in  biotechnology 
and biomanufacturing;  

aim  to  operate  state-of-the-art  equipment,  laboratories  and  technical  expertise 
to  support  biotechnology  and  biomanufacturing  processes  and  provide  access 
thereof;  

aim to support hands-on and work-based training programmes aligned with the 
Union’s skills and workforce development objectives in the biotechnology and 
biomanufacturing sectors or in relation to enabling technologies, such as digital 

2. 

1. 

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technologies,  with 
biomanufacturing; 

specific 

applicability 

in 

biotechnology 

and 

(d) 

(e) 

conduct applied research in biotechnology or biomanufacturing, or in relation 
to  enabling  technologies,  with  specific  applicability  in  biotechnology  and 
biomanufacturing; 

seek  to  engage  in  partnerships  among  industry,  academia,  and  public 
authorities  to  ensure  the  integration  of  research,  innovation,  and  training  in 
biotechnology and biomanufacturing or their enabling technologies. 

Article 6 

Centres of excellence for advanced therapies  

1. 

To enable access to the support measures laid down in  Section 2 of Chapter II, the 
Commission  shall  recognise  projects  located  in  the  Union  as  high  impact  health 
biotechnology  strategic  projects  in  the  form  of  centres  of  excellence  for  advanced 
therapies, including for advanced therapy medicinal products (ATMPs), only where 
they comply with the conditions laid down in Article 4[(1) and reinforce the Union’s 
capability in the area of advanced therapies, by fulfilling all of the conditions set out 
in paragraph 2 of this Article. 

2. 

The centres referred to in paragraph 1 shall fulfil all of the following conditions: 

(a) 

specialise in at least one advanced therapy, such as cell and gene therapies;  

(b)  provide  or  coordinate  advanced 

including  downstream 
processing,  delivery  models  and  the manufacturing of therapies referred  to  in 
point (a); 

infrastructures 

(c) 

(d) 

(e) 

integrate  quality,  regulatory  science,  and  safety  testing  functions  supporting 
Union-wide development of advanced therapies; 

establish structured cooperation among clinical centres, research organisations, 
industrial developers of biotechnology products, investors and regulators; 

provide  multiple  services  enabling  the  transition  of  advanced  therapies  from 
laboratory research to commercial manufacturing, including: 

(i) 

provide  acceleration  programmes  to  transform  innovative  ideas  into 
viable business propositions; 

(ii)  provide 

incubation  programmes  assisting  early-stage  companies 

requiring GMP infrastructure, technical and regulatory expertise; 

(iii)  carry out networking and partnership facilitation to foster alliances; 

(iv)  ensure  access  to  clinical  and  hospital  settings,  including  for  paediatric 

patients, for testing, clinical validation, and feedback;  

(v)  provide  education  and 

training 

for 

researchers,  clinicians,  and 

developers; and 

(vi)  ensure the possibility of cross-border access to  users from any Member 

State. 

3. 

The  Commission  may  adopt  implementing  acts  to  detail  the  conditions  listed  in 
paragraph  2  of  this  Article,  with  a  view  to  ensure  a  consistent  approach  in  their 

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implementation across the Member States. These implementing acts shall be adopted 
in accordance with the examination procedure referred to in Article 65(2).  

Article 7 

Designation of the competent authority responsible for assessing applications for 

recognition of health biotechnology strategic projects and high-impact health 
biotechnology strategic projects  

1. 

2. 

Member  States  shall  designate  an  authority  (‘the  designated  authority’)  responsible 
for  assessing  applications  for  recognition  of  health  biotechnology  strategic  projects 
and high impact health biotechnology strategic projects.   

Member States shall  inform the Commission  within  six  months  from  the  entry into 
force of this Regulation of the authority designated pursuant to paragraph 1. 

Application for recognition of a health biotechnology strategic projects or a high impact 

health biotechnology strategic project 

Article 8 

1. 

2. 

1. 

2. 

3. 

4. 

An  application  for  the  recognition  of  a  project  as  a  health  biotechnology  strategic 
project or as a high impact health biotechnology strategic project shall be submitted 
by  the  project  promoter  to  the  designated  authority  referred  to  in  Article  7  of  a 
Member State on whose territory the project is located. 

The  application  referred  to  in  paragraph  1  of  this  Article  shall  contain  the  
 relevant evidence related to the fulfilment of the conditions laid down in Article 3 as 
regards health biotechnology strategic projects or in Article 4, as regards high impact 
health biotechnology strategic projects.  

Article 9 

Recognition by Member States of health biotechnology strategic projects 

The designated authority shall assess the application for the recognition of a project 
as  a  health  biotechnology  strategic  project  within  one  month  of  the  receipt  of  the 
complete application and communicate a reasoned decision to the project promoter. 
The assessment process shall be fair and transparent. 

Where  the  designated  authority  concludes  that  the  project  fulfils  the  conditions  of 
Article 3, it shall recognise the project as a health biotechnology strategic project.  

Member  States  shall  ensure  that  applicants  have  easy  access  to  information  on 
procedures  for  the  settlement  of  disputes  concerning  the  recognition  process, 
including, where applicable, alternative dispute resolution mechanisms provided for 
by national law. 

Where  a  project  is  located  on  the  territory  of  two  or  more  Member  States,  the 
decision  recognising  the  project  as  a  biotechnology  strategic  project  issued  by  the 
designated  authority  of  a  Member  State  shall  be  recognised  by  the  designated 
authorities of other Member States.  

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Recognition by the Commission of high impact health biotechnology strategic projects 

Article 10 

1. 

2. 

3. 

4. 

The designated authority shall assess the application for the recognition of a project 
as  a  high  impact  health  biotechnology  strategic  project  within  one  month  of  the 
receipt  of  the  complete  application  and  shall  communicate  its  assessment  report  to 
the Commission. The assessment process shall be fair and transparent. 

Where  the  designated  authority  concludes  that  the  project  fulfils  the  conditions  of 
Article  4,  the  Commission  shall,  by  means  of  implementing  acts,  adopt  a  decision 
approving  or  rejecting  the  application  for  recognition  referred  to  in  paragraph  1  of 
this  Article,  based  on  the  assessment  referred  to  in  that  paragraph  and  taking  into 
account the views of the Steering Group referred to in Article 20.  

By  way  of  derogation  from  Article  8  and  to  paragraphs  1  and  2  of  this  Article,  a 
project  may  also  be  recognised  as  a  high  impact  health  biotechnology  strategic 
project  in  the  framework  of  calls  for  proposals  launched  under  Union  programmes 
for the purpose of identifying, selecting  and funding such projects, in  line with  the 
basic acts setting up those programmes. 

The  Commission  shall  recognise  a  project  as  a  high  impact  health  biotechnology 
strategic project in the context of a call for proposals where it fulfils the conditions 
set  out  in  Article  4(1)  and  the  specific  criteria  set  out  in  those  calls,  based  on  the 
evidence submitted by the applicant.  

The  Commission  shall  adopt  implementing  acts  laying  down  the  format  of  the 
assessment report referred to in paragraph 1 of this Article and the procedural rules 
for  the  recognition  of  high  impact  health  biotechnology  strategic  projects.  These 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 65(2).  

SECTION [2] 

SUPPORT OF HEALTH BIOTECHNOLOGY STRATEGIC PROJECTS AND HIGH IMPACT HEALTH 
BIOTECHNOLOGY STRATEGIC PROJECTS 

Article 11 

Single points of contact 

1. 

2. 

Each Member State shall designate one or more authorities as single points of contact 
at  the  relevant  administrative  level  to  facilitate  and  coordinate  the  permit-granting 
process  for  health  biotechnology  strategic  projects  and  high  impact  health 
biotechnology  strategic  projects  and  shall  provide  information  on  the  general 
administrative support and the technical and financial support set out in this [Section] 
through a dedicated webpage. 

This single point of contact shall be the same as the single point of contact referred to 
in Article 3(2) of the Regulation (EU) ../.. [Regulation on speeding-up environmental 
impact  assessments  -permitting  regulation],  responsible  for  facilitating  and 
coordinating  all  aspects  of  the  environmental  assessments,  pursuant  to  applicable 
Union and Member States rules.  

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3. 

4. 

5. 

6. 

7. 

8. 

9. 

1. 

2. 

3. 

The single point of contact shall be the sole point of contact for the project promoter 
during the permit-granting process and shall assist the project promoter in handling 
any administrative matter relevant to the permit-granting process.  

It  shall coordinate the exchange of documents and information  between  the project 
promoters and the competent authorities and shall notify the promoter of the outcome 
of  the  decision-making  process  related  to  permit-granting,  in  accordance  with 
national administrative arrangements. The authorities involved in the permit-granting 
process and other authorities concerned shall specify and make available to the single 
point of contact concerned the requirements and the scope of information requested 
of a project promoter. 

The single point of contact shall direct project promoters to the relevant national and 
regional  antennas  of  the  EU  Health  Biotechnology  Support  Network  referred  to  in 
Article 19. 

Project  promoters  shall  be  allowed  to  submit  to  the  single  points  of  contact  any 
documents relevant to the permit-granting process in electronic form. 

Member States shall promote the reuse of existing data, studies and authorisations in 
order  to  avoid  duplication  of  procedures,  reduce  administrative  burden  and  ensure 
consistency  of  decision-making.  For  that  purpose,  they  shall  ensure  that,  when 
assessing  an  application,  competent  authorities  duly  take  into  account  all  relevant 
studies, assessments and valid permits or authorisations already carried out or issued 
for the same project or its components, provided that they remain applicable and up 
to date. 

Member  States  shall  ensure  that  the  single  points  of  contact  and  all  authorities 
involved  in  the  permit-granting  process  have  a  sufficient  number  of  qualified  staff 
and adequate resources. 

Member  States  shall  ensure  that  applicants  have  easy  access  to  information  on 
procedures  for  the  settlement  of  disputes  concerning  the  permit-granting  process, 
including, where applicable, alternative dispute resolution mechanisms provided for 
by national law. 

Article 12 

Priority status of health biotechnology strategic projects 

Health  biotechnology  strategic  projects  shall  be  considered  as  contributing  to  the 
strengthening  of  the  biomanufacturing  capacity  and  to  the  supply  resilience  of 
biotechnology  products  in  the  Union  and,  therefore,  shall  be  considered  to  be  of 
public interest.  

  Health biotechnology strategic projects shall be deemed to contribute to the resilience 
objectives  referred  to  in  Article  14  of  Regulation  [Regulation  on  speeding-up 
environmental impact assessments – permitting regulation].  

For  the  purposes  of  this  Article,  health  biotechnology  strategic  projects  shall  be 
understood to cover also high impact health biotechnology strategic projects.  

High  impact  health  biotechnology  strategic  projects  shall  be  considered  to  be  of 
public  interest  and  may  be  considered  to  have  an  overriding  public  interest  with 
specific  consideration  given  to  the  high  impact  strategic  nature  of  such  projects  in 
accordance with Article 14 of Regulation [Regulation on speeding-up environmental 

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4. 

5. 

6. 

7. 

8. 

9. 

impact  assessments  –  permitting  regulation  ]  and  point  I  of  the  Annex  to  that 
Regulation. 

Where  a  project  is  recognised  as  a  health  biotechnology  strategic  project,  Member 
States  shall  grant  that  project  the  status  of  project  with  the  highest  national 
significance possible, where such a status exists in national law and shall ensure that 
the  relevant  process  for  permit-granting  and  the  licensing  procedures,  including 
environmental  assessments  and  spatial  planning,  are  treated  in  the  most  rapid  way 
possible  in  accordance  with  Union  and  national  law  and  shall  benefit  from  any 
accelerated procedures provided for in applicable Union and national law. 

Health biotechnology strategic projects shall also benefit, where applicable, from the 
tacit-approval  in  accordance  with  Article  14  and  point  II  of  the  Annex  to  [COM 
Proposal  2025(984)  for  a  Regulation  on  speeding-up  environmental  impact 
assessments  – permitting regulation].  

The  permit-granting  process  shall  not  exceed  ten  months  for  health  biotechnology 
strategic  projects,  and  eight  months  for  high  impact  health  biotechnology  strategic 
projects,  from  the  date  of  acknowledgement  of  the  completeness  of  the  permit 
application.  In  duly  justified  cases  requiring  complex  procedures  under  Union  or 
national  legislation,  such  as  in  the  case  of  multi-site  or  multi-purpose  projects,  the 
competent  authority  may  extend  the  period  by  up  to  three  additional  months, 
provided  that  the  reasons  for  such  extension  are  communicated  in  writing  to  the 
project promoter.  

Where  an  environmental  impact  assessment  is  required  pursuant  to  Directive 
2011/92/EU,  the  step  of  the  preparation  of  the  environmental  impact  assessment 
report referred to in Article 1(2), point (g)(i), of that Directive shall not be included 
in the maximum duration of the permit-granting process referred to in paragraph [5] 
of this Article.  

No later than 45 days from the receipt of the permit-granting application, the single 
point of contact shall acknowledge that the application is complete or, if the project 
promoter has not sent all the information required to process the application, request 
the  project  promoter  to  submit  a  complete  application  without  undue  delay, 
specifying which information is missing. In the event that the submitted application 
is deemed to be incomplete for a second time, the single point of contact may, within 
30 days of the second submission, make a second request for information. The single 
point of contact shall not request information in areas not covered in the first request 
for  additional  information  and  shall  be  entitled  only  to  request  further  evidence  to 
complete the identified missing information. The date of the acknowledgement of the 
completeness  of  the  application  from  the  single  point  of  contact  shall  serve  as  the 
start of the permit-granting process for that particular application. 

All dispute resolution procedures, litigation, appeals and judicial remedies relating to 
health biotechnology strategic projects before any national court, tribunal or panel — 
including  mediation  or  arbitration  —  shall  be  treated  as  urgent,  to  the  extent  that 
national  law  allows  such  urgency,  and  without  prejudice  to  the  normal  rights  of 
local  communities.  Project  promoters  of  health 
defence  of 
biotechnology  strategic  projects  shall  be  able  to  avail  themselves  of  such  urgency 
procedures, where applicable.  This  shall  include the dispute-settlement  provision  in 
accordance  with  Article  14  and  point  III  of  the  Annex  to  the  Regulation 
[…][Regulation on speeding-up environmental impact assessments].  

individuals  or 

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1. 

2. 

3. 

4. 

5. 

1. 

Article [13] 

Administrative support  

Upon  request  of  a  project  promoter,  Member  States  shall  provide  administrative 
support  to  biotechnology  projects  located  on  their  territory,  including  health 
biotechnology  strategic  projects  and  high  impact  health  biotechnology  strategic 
projects and shall take all appropriate measures to facilitate their timely and effective 
implementation, including: 

(a) 

assistance  to  project  promoters  to  ensure  compliance  with  applicable 
administrative, regulatory, and reporting obligations; 

(b) 

support and facilitation of permitting and authorisation procedures; and 

(c) 

assistance to inform the public and those in the vicinity of the project with the 
aim of increasing public acceptance of the project; 

High impact health biotechnology strategic projects shall benefit from priority access 
to the administrative support measures referred to in paragraph 1,  

The  administrative  support  referred  to  in  paragraphs  1  and  2  shall  be  provided 
including through the single points of contact and the national and regional antennas 
of the EU Health Biotechnology Support Network referred to in Article 19. 

Member  States  shall  provide  online  and  in  a  centralised  and  easily  accessible 
manner,  information  relevant  to  promoters  of  biotechnology  projects,  including 
health  biotechnology  strategic  projects  and  high  impact  health  biotechnology 
strategic projects covering at least the following elements: 

(a) 

the designated authority referred to in Article 7(1); 

(b) 

the single points of contact referred to in Article 11; 

(c) 

the  national  and  regional  antennas  of  the  EU  Health  Biotechnology  Support 
Network referred to in Article 19;  

(d) 

the permit-granting process, including information on dispute settlement; 

(e) 

(f) 

advice on financing and investment services; 

business  support  services,  including  corporate  tax  declaration,  local  tax  rules 
and labour law.  

When providing the administrative support referred to in paragraph 1 of this Article, 
Member States shall pay particular attention to SMEs, start-ups and scale-ups. Where 
appropriate, Member States shall ensure that a dedicated channel for communication 
with SMEs, start-ups and scale-ups is available within the single points of contact to 
provide  guidance  and  respond  to  queries  related  to  the  implementation  of  this 
Regulation.  

Article 14 

Financial and technical support  

Without  prejudice  to  Articles  107  and 108  TFEU,  Member  States  may  make  use, 
where applicable, of the relevant frameworks for providing public support to  health 
biotechnology  strategic  projects  and  high  impact  health  biotechnology  strategic 
projects,  including  national  promotional  banks  and  other  relevant  public  support 
instruments, as provided for in Article 24, paragraphs (4), (5) and (6). Where public 

EN 

83 

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support is granted, Member States shall ensure that such support is coordinated with 
other support measures at Union or national level and is in line with applicable State 
aid rules.  

2. 

Projects recognised as high impact health biotechnology strategic projects:  

(a)  may be given particular consideration for Union financial support including in 
the form  of blended  financing,  under  Union programmes, funds  and financial 
instruments and for national support as provided for in Article 25, if the basic 
regulations setting up such Union programmes allow it;  

(b) 

shall benefit from priority status in administrative procedures, including in the 
permit-granting process, as provided for in Article 12]and of priority access to 
administrative support referred to in Article 13.  

The  Commission,  in  cooperation  with  the  Member  States  and,  where  appropriate, 
with the Steering Group referred to in Article 20, shall take the following measures 
to support the implementation of health biotechnology strategic projects and of high 
impact  health  biotechnology  strategic  projects,  including  through  the  EU  Health 
Biotechnology Support Network referred to in Article 19:  

(a) 

support project promoters in identifying funding opportunities at Union level, 
and facilitate the liaison between project promoters and investors; 

(b)  promote actions that strengthen the biotechnology innovation ecosystem; 

(c) 

facilitating  access, 
to  relevant  research  and 
technological  infrastructures,  including  where  such  infrastructures  are  funded 
through Union funding programmes, funds and financial instruments. 

in  particular  for  SMEs, 

Article 15 

Networks of health biotechnology clusters 

The Commission and the Member States shall promote and facilitate the cooperation 
and  the  establishment  of  networks  among  promoters  of  health  biotechnology 
strategic  projects,  of  high  impact  health  biotechnology  strategic  projects  and  other 
relevant actors. A particular focus shall be placed on fostering cross-border synergies 
between  regional  and  national  health  biotechnology  clusters,  and  on  supporting  the 
networks constituted under the EU Competitiveness Coordination Tool pilot, in full 
compliance with EU competition law. 

3. 

1. 

2. 

Such networks shall fulfil one or more of the following activities:  

(a) 

facilitate synergies between innovation ecosystems at local, regional and Union 
levels; 

(b) 

support the establishing of EU-wide interregional biotechnology value chains; 

(c) 

pool national and Union resources and facilities across several Member States, 
bridging  and  upscaling  research,  pilot  and  industrial-scale  biomanufacturing, 
including through cooperation between regional biotechnology clusters; 

(d)  provide  transparent,  open,  and  non-discriminatory  cross-border  access  at 
market  prices  to  research  organisations,  SMEs,  start-ups  and  scale-ups, 
healthcare providers, and industrial actors from across the Union; 

EN 

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(e) 

(f) 

facilitate knowledge transfer, standardisation and inter-cluster collaboration, in 
line with competition rules, and the dissemination of best practices;  

promote  the  development  of  infrastructure  and  digital  platforms,  and  AI-
enabled technologies supporting biotechnology and biomanufacturing. 

The  networks  referred  to  in  this  Article  may  establish  governance  arrangements 
appropriate  to  their  objectives  and  may,  where  necessary,  constitute  themselves  as 
legal  entities  under  Union  law,  as  appropriate  for  the  implementation  of  specific 
actions and investments.  

The Steering Group referred to in Article 20 shall provide advice for the support of 
the federation and networking of biotechnology clusters.  

SECTION 3 

ACCESS PRINCIPLES AND STRATEGIC MAPPING 

Article 16 

Access principles and security safeguards 

Health  biotechnology  strategic  projects  and  high  impact  health  biotechnology 
strategic projects recognised in accordance with this Regulation that receive financial 
support in accordance with Union programmes shall offer open, non-discriminatory, 
transparent,  and criteria-based access  at  market  prices to  their facilities, equipment, 
services and training programmes for users, including SMEs, start-ups and scale-ups 
and other industrial actors, research organisations or training institutions. 

The projects referred to in the first subparagraph shall ensure that access to, and the 
operation  of  their  infrastructures,  facilities  and  services  comply,  where  applicable, 
with the requirements of Directive (EU) 2022/2555 of the European Parliament and 
of  the  Council67,  including  with  the  relevant  cybersecurity  risk-management  and 
reporting obligations.  

The  access  criteria  referred  to  in  paragraph  1  of  this  Article  shall  ensure 
proportionality  and fair treatment  among  users,  while taking into account  all  of the 
following: 

(a) 

(b) 

(c) 

the objectives and capacity of the infrastructure concerned; 

the need to ensure equitable opportunities in particular for SMEs, start-ups and 
scale-ups and research actors;  

any  safeguards  necessary  for  the  protection  of  security,  confidentiality  or 
economic-security interests, in particular those referred to in paragraph [3].  

In order to safeguard the Union’s security, public order and strategic interests, access 
to biotechnology infrastructures and biotechnology datasets of projects referred to in 

Directive  (EU)  2022/2555  of  the  European  Parliament  and  of  the  Council  of  14  December  2022  on 
measures  for  a  high  common  level  of  cybersecurity  across  the  Union,  amending  Regulation  (EU)  No 
910/2014  and  Directive  (EU)  2018/1972,  and  repealing  Directive  (EU)  2016/1148  (NIS  2  Directive) 
ELI: 
EEA 
(Text 
http://data.europa.eu/eli/dir/2022/2555/oj 

27.12.2022, 

relevance), 

80–152. 

with 

333, 

pp. 

OJ 

L 

3. 

4. 

1. 

2. 

3. 

67 

EN 

85 

  EN 

 
 
 
paragraph 1 of this Article shall be governed by the rules laid down in the relevant 
Union funding programmes under which those projects are funded.   

Article 17 

Strategic mapping of the Union’s biotechnology ecosystem 

The Commission, in close cooperation with the Steering Group referred to in Article 
20  and  where  appropriate  the  AI  Board  established  under  the  Regulation  (EU) 
2024/1689, shall conduct, no later than six months after the entry into force of this 
Regulation,  and  maintain  thereafter  a  strategic  mapping  of  the  biotechnology 
ecosystem in the Union. 

The  strategic  mapping  shall  provide  a  comprehensive  overview  of  the  Union’s 
biotechnology  and  biomanufacturing  landscape,  to  assess  existing  capacities  and 
infrastructures,  detect  gaps,  unused  capacities,  dependencies,  and  systemic 
challenges across the value chains. It shall cover in particular  the following areas:  

(a) 

(b) 

(c) 

(d) 

(e) 

industrial  capacity  and  infrastructures,  including  on  critical  intermediates  and 
key  input,  relevant  to  biotechnology  research,  development,  testing,  and 
manufacturing,  and  assessment  of  their  distribution,  interconnections  and 
potential gaps; 

access to risk-tolerant capital, by analysing public and private funding sources 
supporting biotechnology across all stages of development and identifying gaps 
in risk-tolerant financing and market incentives; 

biotechnology clusters and biomanufacturing ecosystems, by mapping existing 
and  planned  clusters  across  the  Union  and  assessing  opportunities  for 
interregional 
coordination, 
collaboration; 

cross-border 

investment, 

and  both 

and 

skills,  upskilling  and reskilling, by analysing current  and projected workforce 
needs,  identifying  gaps  in  education  and  training,  and  assessing  measures  to 
attract, retain, and upskill talent; 

use  of  data  and  AI,  by  assessing  access  to  data,  computing  and  digital 
infrastructures  for  biotechnology  and  identifying  opportunities  to  foster 
responsible AI-enabled innovation and mitigate related risks. 

The strategic mapping shall be based on information from relevant Union bodies and 
agencies,  and,  where  appropriate,  industry  stakeholders  and  research  organisations. 
The  Commission  may  request  Member  States  to  submit  data  necessary  for  this 
purpose,  while  ensuring  the  protection  of  confidential  and  commercially  sensitive 
information.  The  Member  States  shall  submit  such  data  within  30  days  from  the 
request of the Commission.  

The Commission shall present the findings of the strategic mapping to the Steering 
Group. 

The results of the strategic mapping shall be used for the following purposes: 

(a) 

supporting  the  identification  and  prioritisation  by  the  Member  States  and  the 
Commission,  as  appropriate,  of  potential  health  biotechnology  strategic 
projects and high impact health biotechnology strategic projects;  

1. 

2. 

3. 

4. 

5. 

EN 

86 

  EN 

 
(b) 

(c) 

informing  Union  policy  and  funding  priorities 
in  biotechnology  and 
biomanufacturing,  including  actions  in  accordance  with  this  Regulation,  as 
well  as  initiatives  under  Union  programmes  supporting  research,  innovation, 
skills development and industrial competitiveness; 

informing  the  advice  of  the  Steering  Group  on  health  biotechnology  strategic 
projects  and  high-impact  health  biotechnology  strategic  projects  and  on 
initiatives supporting research, innovation, skills and industrial competitiveness 
in the biotechnology sector.    

Article 18 

More favourable treatment 

The provisions of this Regulation regarding the permit granting process, the priority status of 
health  biotechnology  strategic  projects  and  of  high  impact  health  biotechnology  strategic 
projects  and  support  for  such  projects  shall  apply  without  prejudice  to  more  favourable 
provisions laid down in other Union rules. 

SECTION 4 

EU HEALTH BIOTECHNOLOGY SUPPORT NETWORK 

Article 19 

EU Health Biotechnology Support Network 

1. 

2. 

The  Commission  shall  set  up,  coordinate  and  support  an  EU  Health  Biotechnology 
Support Network (‘the Network’), consisting of national and regional antennas in the 
Member States (‘the antennas’).  

The  Network  shall  assist  and  support  the  developers  of  health  biotechnology 
products, in particular SMEs, start-ups and scale-ups, the promoters of biotechnology 
projects,  including  health  biotechnology  strategic  projects  and  high  impact  health 
biotechnology  strategic  projects  (‘project  promoters’)  in  identifying  the  relevant 
applicable rules and funding, scaling-up and networking opportunities.  

3. 

The Network shall fulfil in particular the following missions:   

(a) 

(b) 

(c) 

provide  information  on  the  national  and  Union  rules  applicable  to  the 
development  and  placing  on  the  market  of  health  biotechnology  products, 
including  on  the  applicable  authorisation  procedures  for  health  biotechnology 
products; 

information  for  the  identification  and  use  of  the  applicable  regulatory 
frameworks  and  regulatory  support  mechanisms  with  regard  to  innovative 
health biotechnology products, as provided for in Article 34; 

facilitate the interactions of project promoters with potential public and private 
investors  including  venture-capital  funds,  corporate  partners  and  national 
promotional  banks  and  relevant  funding  structures  and  existing  networks  of 
investors,  including  with  the  European  Innovation  Council  Trusted  Investors 

EN 

87 

  EN 

 
Network68  through  matchmaking  initiatives,  including  host  pitch  sessions, 
demo  days  and  investor  forums,  in  cooperation  with  the  Steering  Group 
referred to  in  Article  20, the European  Innovation Council and other  relevant 
Union initiatives; 

(d)  provide information and support to project promoters for intellectual property 
procedures and technology transfer and promote investors’ awareness of Union 
regulatory frameworks and responsible-innovation principles;  

(e) 

(f) 

support  project  promoters  in  the  identification  of  scaling  up  resources, 
including business support networks providing advice on commercial readiness 
of health biotechnology projects and testing and training facilities, state-of-the-
art  pilot  plant  facilities  that  simulate  a  real  production  environment,  and 
relevant  research  and  technology  infrastructures  across  the  Union,  including 
technology  centres,  cutting-edge  facilities,  and  data-sharing  platforms  to 
support the development and testing of health biotechnologies;  

support biotechnology actors in the responsible and effective integration of AI, 
by  providing  sector-specific  guidance  and  promoting  best  practices  and 
standards for trustworthy AI, in coordination with the bodies established under 
Regulation  (EU)  2024/1689,  and  by  providing  information  and  support,  in 
particular to SMEs, start-ups and scale-ups; 

(g) 

facilitate  liaison  and  exchanges  among  project  promoters  with  a  view  to 
fostering networking and cooperation, including to support networks of health 
biotechnology clusters referred to in Article 15; 

(h)  provide 

incubation, 

acceleration 

for 
biotechnology  start-ups  and  scale-ups  and  connect  project  promoters  with 
projects  and  initiatives  that  address  skills  and  expertise  needs  in  health 
biotechnology  and  biomanufacturing,  including  with  testing,  training  and 
technical support facilities, and regional skills partnerships;  

and  mentorship  programmes 

(i) 

support Member States and the single points of contact in facilitating projects 
promoters’  access  to  administrative  support  provided  in  accordance  with 
Article 13. 

The Network shall complement and, to the extent possible, rely on existing relevant 
organisations and networks at Union and Member State and regional level, including 
the European Enterprise Network. 

The  Commission  shall  select  the  members  of  the  Network  based  on  criteria  made 
public  pertaining  to  the  expertise  and  capabilities  required  to  fulfil  the  missions 
referred  to  in  paragraph  3  of  this  Article,  including  to  the  ability  to  leverage, 
complement  and  strenghten  existing  national  and  European  networks  that  support 
SMEs, start-ups and scale-ups, and innovators. 

The  Commission  shall  organise  the  management,  coordination  and  support  of  the 
Network. 

The  European  Innovation  Council  (EIC)  Trusted  Investor  Network  brings  together  investors from 
across  Europe,  including  venture  capital  funds,  public  investment  banks,  foundations,  and  corporate 
venture arms with experience and commitment to co-invest in promising deep tech start-ups in Europe, 
at: 
alongside 
https://eic.ec.europa.eu/eic-fund/trusted-investor-network_en 

Innovation  Council  Fund.  List  of  members 

the  European 

accessible 

4. 

5. 

68 

EN 

88 

  EN 

 
 
6. 

7. 

1. 

2. 

1. 

2. 

3. 

4. 

The Commission may support the Network through Union  funds, programmes, and 
instruments,  in  accordance  with  the  objectives  established  in  their  respective  basic 
acts. 

Member  States  shall  take  all  necessary  measures  to  facilitate  the  fulfilment  of  the 
tasks of the Network.  

SECTION 5 

EUROPEAN HEALTH BIOTECHNOLOGY STEERING GROUP 

Article 20 

European Health Biotechnology Steering Group 

The  European  Health  Biotechnology  Steering  Group  (the  “Steering  Group”)  is 
hereby established. 

The  Steering  Group  shall  provide  advice  to  the  Commission  and  to  the  Member 
States to facilitate the implementation of this Regulation and shall carry out the tasks 
provided for in this Regulation. 

Article 21 

Composition and functioning of the Steering Group 

The  Steering  Group  shall  be  composed  of  representatives  from  all  Member  States 
and the Commission. It shall be chaired by a representative of the Commission (the 
‘Chair’).  

Each  Member  State  shall  nominate  a  member  and  an  alternate  member  as  its 
representatives  to  the  Steering  Group.  Where  relevant  as  regards  function  and 
expertise, a Member State may nominate different  representatives in  relation to  the 
different subgroups of the Steering Group, while not exceeding a representative per 
subgroup.  Nominated  permanent  representatives  shall  ensure 
the  necessary 
coordination  within  their  respective  Member  State.  The  Commission  and  the 
Member States shall have voting rights. 

The  Steering  Group  shall,  upon  a  proposal  by  the  Commission,  adopt  its  rules  of 
procedure  by  a  simple  majority  of  its  members.  Where  appropriate,  the  Chair  may 
invite external experts to attend meetings of the Steering Group. 

The Steering Group shall meet as needed in order to allow the effective performance 
of  its  tasks  provided  for  in  this  Regulation.  Where  necessary,  the  Steering  Group 
shall  meet  on  the  basis  of  a  reasoned  request  by  the  Commission  or  by  a  Member 
State. The Commission shall coordinate the work of the Steering Group by means of 
a secretariat that provides technical and logistical support. 

5. 

The Steering Group shall carry out the following tasks: 

(a) 

facilitate  the  exchange  of  information  and  best  practices  among  Member 
States, the Commission, and relevant stakeholders in relation to the recognition 
and  the  implementation  of  health  biotechnology  strategic  projects  and  high 
impact health biotechnology strategic projects; 

EN 

89 

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(b)  discuss,  at  least  once  a  year,  the  progress  in  the  recognition  of  health 
biotechnology strategic projects and high impact health biotechnology strategic 
projects  and  provide  advice  including  to  overcome  systemic  challenges  faced 
by such projects;  

(c) 

provide advice for supporting the federation and networking of biotechnology 
clusters, as provided for in Article [15[(4)];  

(d)  discuss  and  coordinate  funding  for  health  biotechnology  strategic  projects, 
including  high-impact  health  biotechnology  strategic  projects,  without 
prejudice to the basic acts of the relevant Union programmes; this may include 
facilitating  the  liaison  between  project  promoters  and  potential  private  and 
public  investors,  such  as  the  European  Investment  Bank  Group,  national 
promotional  banks  and  institutions  and  export  credit  agencies,  to  mobilise 
additional financing, including from private or venture capital sources;  

(e) 

(f) 

provide its views regarding the recognition of a project as a high impact health 
biotechnology strategic project, in accordance with Article [10][(2)];  

facilitate the coordination and information exchange among the Member States 
on  enforcement  of  the  biosecurity  provisions  in  this  Regulation  and  other 
emerging biosecurity topics. 

The Steering Group may establish subgroups for the purpose of this Regulation.  

The Steering Group shall take the necessary measures to ensure the safe handling and 
processing of confidential and commercially sensitive information. 

The Steering Group shall use its best endeavours to reach consensus, where possible. 
Members  with  diverging  positions may request  that  their positions and the grounds 
on which they are based be recorded in the Steering Group’s position. 

CHAPTER III 

ACCESS TO FUNDING 

Article 22 

EU health biotechnology investment pilot 

To  support  the  financing  of,  and  investments  in,  companies  and  projects  falling 
within  the  scope  of  this  Regulation,  the  Commission,  together  with  the  European 
Investment Bank Group (EIBG) or other implementing partners, shall develop an EU 
Health  Biotechnology  investment  pilot  (‘the  pilot).  The  pilot  is  established  for  an 
initial period of two years, after which it shall be reviewed. 

The  pilot  shall  support  the  full  lifecycle  of  companies  and  projects  in  the  area  of 
health  biotechnology,  including  SMEs,  start-ups  and  scale-ups  through  direct  and 
indirect financing, other than direct equity operations, without prejudice to the basic 
acts  to  be  agreed  under  the  next  Multiannual  Financial  Frameworks.  It  shall 
complement  and  be  developed  in  a  coordinated  manner  with  other  EU  financing 
instruments.  

The  pilot  shall  be  designed  as  a  mechanism  that  may  use  and  leverage  different 
funding  streams  and  instruments  to  accelerate  and  catalyse  investments  into  the 

6. 

7. 

8. 

1. 

2. 

3. 

EN 

90 

  EN 

 
 
health biotechnology sector. It may be used to provide Union support through Union 
programmes. 

4. 

The pilot shall pursue the following objectives: 

(a) 

support  early-stage  applied  research  and  innovation,  technology  transfer  and 
spin-offs, with appropriate financing mechanisms, including equity;  

(b)  provide support to projects, SMEs, including start-ups and scale-ups, and mid-
caps  across  the  Union,  which  are  providing  solutions  and  developments  that 
contribute to the objectives of this Regulation;  

(c) 

(d) 

finance  late-stage  development  initiatives,  industrial  scale-up  and  production 
capacity  build-up  for  companies  that  contribute  to  the  objectives  of  this 
Regulation,  through  venture  loans  and  other  suitable  debt  or  quasi-equity 
instruments; 

anchor  growth  and  manufacturing  activities  in  the  Union  in  order  to  gain  or 
maintain strategic autonomy and resilience, as well as boost competitiveness of 
the sector; 

(e)  mobilise  private  investments,  including  from  institutional  investors  such  as 
pension  funds,  and  strengthen  the  availability  of  long-term  risk  finance  for 
biotechnology companies established in the Union. Financial actors, including 
private  institutional  investors,  shall  be  targeted  by  leveraging  expertise  in 
catalysing  private  capital  and  use  appropriate  risk-sharing  mechanisms  to 
achieve this objective; 

(f) 

assist  early  and  growth-stage  companies  through  blended  and  concessional 
finance,  encompassing  equity  or  debt  operations,  complementing  the  direct 
equity  support  provided  by  the  European  Innovation  Council  Fund  and  the 
Scale-Up  Europe  Fund  under  the  Horizon  Europe,  including  via  the 
development of new products; 

(g)  provide  advisory  support  throughout  the  investment  cycle,  encompassing 
concrete  capacity-building  measures.  These  interventions  shall  be  aimed  at 
reinforcing the competencies and institutional preparedness of developers and 
promoters of projects and financial intermediaries to successfully develop and 
implement their initiatives. 

Article 23 

EU biotechnology late-stage capital booster pilot  

1. 

To enable access to the support measures laid down in Section 2 of Chapter II, the 
Commission  shall  recognise  projects  located  in  the  Union  contributing  to  an  EU 
biotechnology  late-stage  capital  booster  as  high-impact  health  biotechnology 
strategic  projects,  only  where  in  addition  to  the  conditions  laid  down  in  Article 
[4][(1)], the projects facilitate access to capital markets in accordance with applicable 
law,  and  are  led  by  private-sector  operators  or  consortia,  with  the  potential 
participation of market-infrastructure providers and investors. 

EN 

91 

  EN 

 
 
 
2. 

The  projects  referred  in  paragraph  1  of  this  Article  shall  pursue  at  least  one  of  the 
following objectives or activities: 

(a) 

facilitating cross-border investment in accordance with Union law; 

(b)  mobilising  long-term  capital  and  attracting  private  investment,  including 
institutional investors, and through private markets, with credible commitments 
or structures that support liquidity and follow-on financing; 

(c) 

improving  cross-border  investors’  access  and  issuers’  visibility  through 
practical  steps  and  deliverables  and  demonstrating  a  credible  issuance  and 
investor pipeline with target numbers and timelines; 

(d) 

enhancing  biotechnology 
sector-specific 
exchange of best practices on these topics ; 

investment  expertise 

through 

(e)  mobilising  private  capital  through  biotechnology  accelerators  and  venture 

builders, including potential use of risk-sharing mechanisms. 

3. 

The projects referred in paragraph 1 shall: 

(a) 

ensure  non-discriminatory,  transparent  and  criteria-based  access  for  eligible 
issuers;  

(b) 

ensure the possibility of cross-border participation from any Member State;  

(c) 

proportionate 

include 
reporting 
arrangements  and  operate  without  prejudice  to  applicable  Union  financial 
services legislation and the mandates of competent authorities. 

risk-management, 

governance 

and 

4.  

The provisions of this Regulation regarding the application for, and the recognition 
of,  high-impact  health  biotechnology  strategic  projects  laid  down  in  Articles  8  and 
[10], respectively, apply to projects referred to in this Article. 

Article 24 

Biotechnology as a strategic technology eligible for Union and national financial support 

1. 

2. 

3. 

4. 

Union  programmes  may  support  biotechnology  as  a  strategic  technology  for  the 
Union’s  innovation  capacity,  sovereignty,  resilience  and  leadership  in  line  with  the 
objectives set out in the Regulations establishing those Union programmes. 

The Commission may adopt calls, windows or compartments for biotechnology and 
may  establish  instruments  in  the  implementation  of  those  programmes,  funds  and 
instruments,  that  support  biotechnology  companies,  projects  and  initiatives  falling 
within the scope of this Regulation, in line with the objectives and rules set out in the 
regulations establishing those programmes, funds and instruments.  

Companies,  projects  and  initiatives  falling  within  the  scope  of  this  Regulation  may 
be targeted for financial support from Union-led funding initiatives and from Union 
funding  programmes  and  instruments,  as  projects  in  a  strategic  technology  and,  as 
appropriate, in a strategic deep tech area. 

Member States may, in line with applicable State aid rules, provide financial support 
to  biotechnology  as  a  strategic  technology  for  the  Union’s  innovation  capacity, 
sovereignty, resilience and leadership. 

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5. 

6. 

1. 

2. 

3. 

4. 

Member States shall pursue the support as referred to in paragraph 4, including for 
health  biotechnology  strategic  projects  and  high  impact  health  biotechnology 
strategic  projects,  in  the  implementation  at  national  level  of  the  relevant  Union 
programmes that are shared-management basic acts.  

Where  State  aid  instruments,  designed  in  compliance  with  Union  competition  law 
and making use of related EU guidance, are used by Member States for the purpose 
of supporting  the health  biotechnology  sector or  parts thereof, Member States  shall 
give  particular  consideration  to  high-impact  health  biotechnology  strategic  projects 
for support under such instruments. 

Article 25 

Funding for high impact health biotechnology strategic projects  

High  impact  health  biotechnology  strategic  projects  may  be  given  particular 
consideration for financial support under Union funds, programmes and instruments 
in accordance with the objectives set out in the regulations establishing those funds, 
programmes and instruments.  

Where  high  impact  health  biotechnology  strategic  projects  benefit  from  financial 
support  under  Union  funds,  programmes  and  instruments,  in  accordance  with  the 
respective  legal  bases  and  eligibility  criteria  of  those  funds,  programmes  and 
instruments,  such  support  may  be  used  in  combination  with  financing  from  the 
European Investment Bank Group, from national promotional banks and institutions 
or from other development or public financial institutions, as well as in combination 
with  financing  from  private-sector  finance  institutions  and  from  public-sector  or 
private-sector 
through  public–public  or  public–private 
partnerships. 

investors, 

including 

When preparing and implementing the annual and multiannual work programmes of 
the relevant Union funds, programmes and instruments referred to in paragraph 1, the 
Commission  may  give  particular  consideration  to  actions  supporting  high-impact 
health biotechnology strategic projects.  

The Commission  shall ensure the  coordination and the complementarity  among  the 
relevant  Union  funds,  programmes  and  instruments  that  support  actions  under  this 
Regulation,  and  shall  provide  strategic  guidance  for  the  implementation  of  such 
funds,  programmes  and  instruments  with  regard  in  particular  to  the  high  impact 
health  biotechnology  strategic  projects,  including  in  cooperation  with  the  Steering 
Group, referred to in Article 20, where appropriate. 

Article 26 

Coordination of financing for health biotechnology strategic projects 

The  Steering  Group  referred  to  in  Article  20  may  coordinate  investments  into  health 
biotechnology  strategic  projects,  including  high  impact  health  biotechnology  strategic 
projects, with the project promoters and other relevant interested parties, in compliance with 
Union competition law.  

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CHAPTER IV 

EXTENSION OF THE SUPPLEMENTARY PROTECTION CERTIFICATE 

Extension of the supplementary protection certificate concerning best-in-class 

biotechnology medicines developed in the Union 

Article 27 

Where a marketing authorisation is granted by the Union to a medicinal product for 
human  use  developed  by  means  of  biotechnological  processes  referred  to  in 
paragraph  1  of  Annex  I  to  Regulation  (EU)  …/…  [reference  to  be  added  after 
adoption  cf.  COM(2023)  193  final]  or  to  an  advanced  therapy  medicinal  product 
referred  to  in  paragraph  2  of  that  Annex,  and  that  is  protected  either  by  a 
supplementary  protection  certificate  in  accordance  with  Regulation  (EC)  No 
469/2009  of  the  European  Parliament  and  of  the  Council69,  or  by  a  patent  which 
qualifies for the granting of such supplementary protection certificate, the holder of a 
patent or of such certificate shall be entitled to a 12-month extension of the periods 
referred  to  in  Article  13,  paragraphs  (1)  and  (2),  of  Regulation  (EC)  No  469/2009, 
provided  that  the  marketing  authorisation  applicant  demonstrates  that  all  of  the 
following conditions are met: 

(a) 

(b) 

(c) 

the medicinal product contains a new active substance distinctly different from 
that of any authorised medicinal product in the Union; 

the medicinal product has a mechanism of action distinctly different and shows 
a  level  of  safety  and  efficacy  which  is  at  least  equivalent  to  that  of  any 
authorised medicinal product in the Union for the same disease; 

the  clinical  trials  evaluating  the  efficacy  of  the  medicinal  product  and 
supporting  its  marketing  authorisation  were  conducted  in  more  than  two 
Member States;  

(d) 

at  least  a  manufacturing  step,  excluding  packaging,  quality  testing  and 
certification is performed in the Union. 

The  European  Medicines  Agency  (‘the  Agency’)  shall  assess  compliance  with  the 
conditions referred to in paragraph 1 as part of the marketing authorisation procedure 
concerned. 

Where compliance is confirmed, the Agency shall issue a statement to that effect. 

A copy of the statement referred to in paragraph 3 of this Article shall be included in 
the  application  for  a  certificate  lodged  under  article  7  of  Regulation  (EC)  No 
469/2009. 

1. 

2. 

3. 

4. 

69 

Regulation  (EC)  No  469/2009  of  the  European  Parliament  and  of  the  Council  of  6  May  2009 
concerning the supplementary protection certificate for medicinal products, OJ L 152, 16.6.2009, pp. 1. 

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CHAPTER V 

ENHANCING COMPETITIVENESS IN BIOSIMILARS  

Article 28 

Guidance by the Agency on biosimilars  

The  Agency,  in  consultation  with  the  Commission,  shall  develop  and  update  non-binding 
guidance  on  a  tailored  regulatory  approach  for  the  development  of  biosimilars,  reflecting 
advances  in  manufacturing  and  analytical  testing.  The  guidance  shall  consider  a  potential 
reduction  of  the  clinical  data  required  for  the  development  and  approval  of  biosimilars, 
without affecting their quality, safety and efficacy. 

Article 29 

Biotechnology health strategic projects for biosimilars  

To  enable  access  to  the  support  measures  laid  down  in  Section  II  of  Chapter  II,  Member 
States shall recognise projects located in the Union as biotechnology health strategic projects 
in the form of biotechnology health strategic projects for biosimilars only where they make a 
substantial contribution to at least one the specific objectives referred to in Article [3][(1)] and 
fulfil either of the following conditions: 

(a) 

(b) 

they  contribute  to  the  setting  up  and  extension  of  innovative  biomanufacturing 
capacity, and infrastructures for analytical testing procedures;  

they  contribute  to  the  research,  development  and  marketing  authorisation  of 
biosimilars, and where appropriate to strengthening the use of platform technologies; 
this  includes  analytical  methodologies  that  would  reduce  the  need  for  clinical  data 
for biosimilars, without affecting their quality, safety and efficacy. 

Article 30 

International partnerships 

Where appropriate, promoters of projects related to biosimilars and other companies working 
in  this  area,  shall  explore  opportunities  to  establish  or  strengthen  cooperation  with 
international biotechnology clusters, including with a view to fulfilling the conditions referred 
to in Article [29] for the recognition of biotechnology health strategic projects for biosimilars. 

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CHAPTER VI 

ARTIFICIAL INTELLIGENCE AND DATA AS BIOTECHNOLOGY ENABLERS 

Article 31 

Guidance on the deployment and use of systems based on advanced technologies, 

including AI, in the lifecycle of medicinal products 

1. 

The Agency shall publish and regularly update, as appropriate, non-binding guidance 
on  the  deployment  and  use  of  systems  based  on  advanced  technologies,  including  
AI, in the lifecycle of medicinal products development, including during pre-clinical 
research,  clinical  development  and  trials,  manufacturing  and  post-authorisation 
monitoring.  

Such  guidance  shall  be  developed,  updated  and  published  in  agreement  with  the 
Commission, including with the AI Office.  

Such  guidance  shall  ensure  full  coherence  with  the  requirements  laid  down  in 
Regulation  (EU)  2024/1689  and  with  any  guidance  issued  under  that  Regulation 
regarding general-purpose AI models or AI systems.  

2. 

In developing and updating the guidance referred to in paragraph 1, the Agency shall 
consult the relevant authorities, at national  and European level, and stakeholders as 
appropriate.  

3. 

1. 

To the extent that the guidance concerns the deployment and use of systems based on 
advanced technologies, including AI, across the clinical trials lifecycle, the Agency 
shall  further  cooperate  with  the  Clinical  Trials  Coordination  [and  Advisory]  Group 
(‘CTAG’)  referred  to  in  Article  [85]  of  Regulation  (EU)  No  536/2014,  with  the 
Medical  Device  Coordination  Group  (‘MDCG’)  referred  to  in  Article  103  of 
Regulation (EU) 2017/745 and with the Artificial Intelligence Board  referred to in 
Article  65  of  Regulation  (EU)  2024/1689,  as  appropriate  and  shall  publish  that 
guidance in agreement with the consulted entities referred to in this subparagraph. 

The Agency shall develop and publish in agreement with the Commission, including 
the  AI  Office  where  appropriate,  and  in  cooperation  with  the  national  competent 
authorities,  non-binding  guidance  on  the  deployment  and  use  of  advanced 
technologies,  including  AI,  in  the  procedures  for  the  authorisation  of  medicinal 
products. 

Article 32 

Biotechnology testing environments for advanced biotechnology innovations   

To enable access to the support measures laid down in Section 2 of Chapter II, the 
Commission  shall  recognise  projects  located  in  the  Union  as  high  impact  health 
biotechnology  strategic  projects  in  the  form  of  trusted  testing  environments  for 
advanced  health  biotechnology  innovations,  where  such  innovations  are  enabled, 
enhanced or significantly supported by AI or advanced computational methods, only 
where  they  comply  with  the  criteria  laid  down  in  Article  4(1)  and  substantially 
strengthens  the  Union’s  capacity  for  responsible  experimentation,  development, 
testing  and  validation  of  such  innovations  and  they  fulfils  all  of  the  following 
conditions:  

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(a) 

(b) 

(c) 

operate  under  trusted  conditions  ensuring  compliance  and  alignment  with 
relevant  Union  and  national  legislation  and  complements  where  appropriate 
testing and experimentation facilities and AI regulatory sandboxes  established 
in  accordance  with  Regulation  (EU)  2024/1689,  while  ensuring  consistency 
and synergies in their implementation; 

seek,  where  appropriate, 
leverage  AI  systems  or  other  advanced 
computational  tools,  alongside  advanced  technologies  and  analytics,  to 
optimise workflows and increase efficiency;  

to 

aim to enable innovation in biotechnology areas where the use of AI-enabled or 
computationally  enhanced  methods  can  be  particularly  impactful,  such  as 
enhancing  efficacy  and  safety  of  immunology  treatments  and  of  ATMP  gene 
therapies,  or  developing  NAMs  that  combine  advanced  experimental  and 
computational approaches; 

(d)  make  available,  under  fair  and  transparent  conditions,  evidence,  results  and 
lessons  learned  generated  within  such  testing  environments,  to  inform  Union 
guidance, 
frameworks,  and,  where 
appropriate,  the  design  or  implementation  of  regulatory  sandboxes  in 
accordance with Union or national law. 

standardisation  and  best-practice 

The  Commission,  in  cooperation  with  the  Member  States,  shall  promote  and 
facilitate, including through existing networks such the European Digital Innovation 
Hubs  and  testing  and  experimentation  facilities  and  relevant  expert  groups 
established  under  Union  legislations,  networking,  knowledge-sharing  and  capacity-
building among projects and initiatives providing such testing environments. 

The provisions of this Regulation regarding the application for, and the recognition 
of, high-impact  health biotechnology strategic projects laid down in Articles 8 and 
10, respectively, apply to projects referred to in this Article. 

Article 33 

Biotechnology data quality accelerator  

To enable access to the support measures laid down in  Section 2 of Chapter II, the 
Commission  shall  recognise  projects  located  in  the  Union  as  high  impact  health 
biotechnology  strategic  projects  in  the  form  of  biotechnology  data  quality 
accelerators, only where they comply with the criteria laid down in Article 4(1) and 
fulfil  the  conditions  laid  down  in  paragraph  2  of  this  Article  and  they  make  a 
significant  contribution  to  the  curation,  maintenance  and  responsible  use  of  high-
quality,  appropriately  annotated  and  provenance-verified  datasets  that  are  essential 
for  the  training,  validation  and  testing  of  AI  systems  and  models  used  in  health 
biotechnology applications. 

2. 

3. 

1. 

2. 

The projects referred to in paragraph 1 shall: 

(a) 

aim to foster the development and deployment of trustworthy and competitive 
AI  systems  in  health  biotechnologies,  including  large-scale  and  general-
purpose  models  relevant  for  biological,  biomedical  or  biomanufacturing  use 
cases; 

(b) 

assist  entities  that  lawfully  hold  relevant  data  and,  as  regards  health  data, 
holders  as  defined  in  Article  2(2),  point  (t),  of  Regulation  (EU)  2025/327 

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(‘health  data  holders’)  to  improve  data  quality,  standardize  and  make  other 
improvements to such data as referred to in paragraph 1 of this Article; 

(c)   contribute to the development of Union standards and quality frameworks for 
in 

interoperability  and  annotation 

data  representativeness,  provenance, 
biotechnology;  

(c) 

give due consideration to the interoperability with platforms deployed pursuant 
to the European Health Data Space (EHDS) and other relevant data spaces; 

(d)  be  aligned  with  and  complement  Union  initiatives  such  as  the  Data  Union 
Strategy,  including  data  labs  and  AI  factories,  while  addressing  the  specific 
requirements  of  biotechnology  datasets, 
including  biological  metadata, 
scientific  taxonomies,  experimental  traceability  and  regulatory-grade  data 
quality.  

The provisions of this Regulation regarding the application for, and the recognition 
of,  high-impact  health  biotechnology  strategic  projects  laid  down  in  Articles  8  and 
10, respectively, apply to projects referred to in this Article. 

The  processing  of  personal  data  by  the  entities  that  lawfully  hold  the  relevant 
datasets enhanced as provided for in paragraph 2, point (b) of this Article, and by the 
biotechnology data quality accelerator projects takes place in the public interest. 

Entities that lawfully hold relevant datasets enhanced as provided for in paragraph 2, 
point (b) of this Article, shall make available such datasets under fair, reasonable and 
non-discriminatory conditions, ensuring equitable access for users including research 
organisations,  SMEs  and  public  institutions,  under  the  conditions  referred  to  in 
Article 16 of this Regulation. 

Electronic health data referred to in Article 51 of Regulation (EU) 2025/327 shall be 
made available in accordance with that Regulation.  

Entities that lawfully hold relevant datasets  enhanced as provided for in paragraph 2, 
point  (b)  of  the  Article,  shall  support,  where  appropriate,  the  integration  of  such 
datasets  into  Union  infrastructures,  including  the  European  Research  Area  data 
spaces, data labs, AI factories and the infrastructures operated by high impact health 
biotechnology strategic projects. 

The  decision  of  the  Commission  regarding  the  recognition  of  a  high  impact  health 
biotechnology  strategic  project  in  the  form  of  a  biotechnology  data  quality 
accelerators, referred to in Article 10(2), shall specify the modalities of processing of 
personal  data  necessary  to  achieve  the  purpose  of  the  project.  In  particular  the 
Commission  shall  specify  the  categories  of  data  to  be  processed,  the  roles  of  the 
entities participating in the project, the categories of the entities which may use the 
curated data and the safeguards. 

3. 

4. 

5.  

6. 

7.  

8.     With regard to biotechnology data quality accelerators recognised in the context of a 
call for proposals as provided for in Article 10(3), the Commission shall, by means 
of  implementing  acts,  adopt,  before  the  launch  of  the  related  call,  a  decision 
establishing  the  modalities  of  processing  of  personal  data  necessary  to  achieve  the 
purpose  of  the  project.  That  decision  shall  specify  the  categories  of  data  to  be 
processed, the roles  of the entities participating  in  the project,  the categories of the 
entities  which  may  use  the  curated  data  and  the  safeguards.  The  selected 
beneficiaries shall comply with the conditions laid down in that decision. 

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CHAPTER VII 

REGULATORY TOOLS FOR NOVEL HEALTH BIOTECHNOLOGY PRODUCTS 

SECTION 1 

SUPPORT IN DETERMINING THE REGULATORY STATUS OF NOVEL HEALTH BIOTECHNOLOGY 
PRODUCTS 

1. 

2. 

3. 

Article 34 

Assistance on regulatory procedural pathways  

The EU Health Biotechnology Support Network referred to in Article 19 shall, upon 
request,  assist  developers,  in  particular  SMEs,  start-ups  and  scale-ups,  with 
identifying  and using the appropriate regulatory  procedural  pathway and  regulatory 
support  mechanisms  with  regard  to  innovative  health  biotechnology  products  or 
biotechnology services for human use that exhibit characteristics that raise questions 
on the application or applicability of the Regulation (EU) 2017/745, Regulation (EU) 
2017/746,  Regulation  (EU)  2024/1938,  Regulation  (EU)  …/…  [reference  to  be 
added  after  adoption  cf.  COM(2023)  193  final]    and  Regulation  (EU)  …/… 
[reference  to  be  added  after  adoption  cf.  COM(2023)  192  final]  Regulation  (EC) 
1394/2007  and Directive 2010/45/EU. 

The  support  provided  pursuant  to  this  Article  shall  not  duplicate  procedures 
pertaining  to  recommendations  or  opinions  on  regulatory  status  set  out  in  with  
Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2024/1938, 
Regulation  (EU)  …/…  [reference  to  be  added  after  adoption  cf.  COM(2023)  193 
final]  and  Regulation  (EU)  …/…  [reference  to  be  added  after  adoption  cf. 
COM(2023) 192 final] . 

The  support  referred  to  in  paragraph  1  shall  be  provided  in  particular  on  the 
following: 

(a) 

(b) 

(c) 

procedures for seeking guidance on the regulatory status and on the nature and 
scope of such guidance; 

applicable  rules  for  the  authorisation  of  health  biotechnology  products  that 
combine  different  products,  technologies,  processes,  or  components  regulated 
under different regulatory frameworks; 

regulatory  sandboxes  established  in  Article  40  and  under  [revised  Regulation 
(EU)  2017/745],  [revised  Regulation  (EU)  2017/746],  Regulation  (EU) 
2024/1938 and in Regulation (EU) …/… [reference to be added after adoption 
cf. COM(2023) 193 final].   

4. 

In  providing  the  support  referred  to  in  this  Article,  the  EU  Health  Biotechnology 
Support Network referred to in Article 19 may request the assistance of the Foresight 
Panel for Emerging Health Innovation. 

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Article 35 

Union regulatory status repository 

1. 

2. 

3. 

The  Commission  shall  compile,  maintain,  develop  and  make  publicly  available  a 
regulatory status repository (‘regulatory status repository’). 

The regulatory status repository shall contain: 

(a) 

(b) 

decisions, opinions, scientific recommendations regarding the regulatory status 
of a health innovations, issued pursuant to the mechanisms laid down in Article 
4 of Regulation (EU) 2017/745, Articles 61 and 62 of  Regulation (EU) …/… 
[reference to be added after adoption cf. COM(2023) 193 final], Article 13 of 
Regulation  (EU)  2024/1938,  and,  where  relevant,  pursuant  to  similar 
mechanisms laid down in other legislative acts;  

the  summaries  of  the  scientific  recommendations  delivered  by  the  Agency, 
prior to the application of Regulation (EU) …/… [reference to be added after 
adoption  cf.  COM(2023)  193  final],  in  accordance  with  Article  17  of 
Regulation (EC) No 1394/2007 on whether a product falls within the definition 
of an advanced therapy medicinal product or not; 

(c) 

the  discussion  papers  delivered  by  the  Foresight  Panel  for  Emerging  Health 
Innovation.  

Member States shall make publicly available, through the relevant national platforms 
or  registries,  decisions,  opinions,  scientific  recommendations,  and  other  outputs 
issued  at  national  level  concerning  the  regulatory  status  of  health  biotechnology 
products.  Member  States  shall  inform  the  Commission  where  such  information  is 
made available.  

Article 36 

Time limits in the regulatory status process  

With a view to ensuring the timely assessment of the regulatory status of health biotechnology 
products, the advisory bodies and other relevant entities mandated under [revised Regulation 
(EU)  2017/745,  [revised  Regulation  (EU)  2017/746],  Regulation  (EU)  2024/1938  
Regulation], Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 
final] and Regulation (EU) …/…  [reference to  be added  after adoption cf. COM(2023) 192 
final]  to  provide  a  recommendation  or  opinion,  including  preparatory  consultations,  on  the 
regulatory  status  of  a  product,  shall  act  swiftly,  without  prejudice  to  the  time  limits  for  the 
forming of such recommendations or opinions established in the above legal acts.  

SECTION 2  

FORESIGHT ON EMERGING HEALTH INNOVATION  

Article 37 

Foresight Panel for Emerging Health Innovation  

1. 

A  Foresight  Panel  for  Emerging  Health  Innovation  is  hereby  established  ('the 
Foresight Panel').  

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2. 

The  Foresight  Panel  shall  provide  regulatory,  scientific  and  technical  expertise  on 
emerging science and technology in the field of health underpinning the development 
of  health  biotechnology  products  to  the  Commission,  the  Agency  and  to  relevant 
Union-level  advisory  bodies  and  competent  authorities  and  other  entities  in  the 
Member States in the area of health. The Foresight Panel shall operate in accordance 
with the Commission’s framework for expert groups. 

3. 

The Foresight Panel shall carry out the following tasks: 

(a) 

(b) 

(c) 

(d) 

conduct  horizon  scanning  by  analysing,  identifying  and  discussing  emerging 
science  and  technology  with  the  potential  to  drive  the  development  of  health 
biotechnology  products,  including  upon  request  from  the  Commission,  the 
Agency,  Union-level advisory bodies or competent authorities in the Member 
States in the area of health, and develop and publish related considerations in 
the form of discussion papers  

engage  with  the  Agency  and  relevant  Union-level  advisory  bodies  and 
competent  authorities  and  other  entities  in  the  Member  States  in  the  area  of 
health, to facilitate cross-framework dialogue and consistency;  

engage  with  existing  relevant  networks  to  contribute  to  enhancing  regulatory 
expertise regarding health biotechnology products.  

accommodate  exchanges  among  the  authorities  responsible  for  the  setting  up 
and the operation of regulatory sandboxes in accordance with article 39(5).  

For the purpose of performing the tasks referred to in paragraph 2, point (a), of this 
Article, the Foresight Panel may engage in preliminary discussions with the Agency 
or relevant Union level advisory bodies in the area of health, networks and informal 
task forces, national competent authorities, developers, and other relevant actors and 
shall implement a collaborative approach with a view to ensuring an effective uptake 
of its discussion papers. 

The Foresight Panel shall consist of scientific and regulatory experts from the  SoHO 
Coordination  Board  (‘the  SCB’),  the  Medical  Devices  Coordination  Group  (‘the 
MDCG’),  the  Coordination  group  on  Health  Technology  Assessment  (‘the 
HTACG’),  the  Agency  and  the  competent  authorities  of  the  Member  States, 
appointed  by  the  Commission  in  view  of  their  regulatory,  scientific  or  technical 
expertise  in  the  relevant  identified  fields  and  frameworks.  The  panel  may  invite 
external  experts  selected  to  assist  with  specific  tasks  when  such  relevant  external 
expertise is needed. 

The Commission shall adopt an implementing act laying down detailed rules on the 
selection, composition, number of members, and functioning of the Foresight panel. 
The implementing act shall be adopted in accordance with the examination procedure 
referred to in Article 65(2). 

Article 38 

Support to the Foresight Panel for Emerging Health Innovation 

The Commission shall chair and provide the secretariat for the Foresight Panel and 
shall provide the support necessary to ensure it can efficiently perform its tasks. 

The Commission shall in particular have the following tasks: 

(a) 

to provide administrative and technical support to the Foresight Panel; 

4. 

5. 

6. 

1. 

2. 

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(b) 

to facilitate and manage remote and physical meetings of the Foresight Panel; 

(c) 

(d) 

(e) 

(f) 

(g) 

to ensure that the work of the Foresight Panel is carried out in an independent 
manner; 

to  facilitate  the  dissemination  of  the  discussion  papers  produced  by  the 
Foresight Panel with relevant competent authorities and advisory bodies;  

to  ensure  that  remuneration  and  expenses  are  provided  to  the  experts 
composing the Foresight Panel; 

to monitor compliance with the rules of procedure of the Foresight Panel;  

to  issue  annual  reports  on  the  work  of  the  Foresight  Panel,  including  on  the 
number of discussion papers delivered by the Panel.  

3. 

The Foresight panel shall establish its own rules of procedure. 

SECTION 3 

REGULATORY SANDBOXES AS TOOLS FOR NOVEL HEALTH BIOTECHNOLOGY PRODUCTS 

Regulatory sandboxes provided for in the applicable frameworks and cross-framework 
communication  

Article 39 

1. 

2. 

3. 

4. 

Where  a  regulatory  sandbox  is  established  at  Member  State  level  for  a  health 
biotechnology  product  in  accordance  with  [revised  Regulation  (EU)  2017/745], 
[revised  Regulation  (EU)  2017/746],  Regulation  (EU)  2024/1938,  the  authorities 
responsible  for  the  operation  of  that  sandbox  shall,  where  appropriate  and  in 
accordance  with  the  relevant  legislative  act  referred  to  in  this  paragraph,  conduct 
consultations with the competent authorities and the Commission, responsible for the 
operation of sandboxes under the other relevant Union legislative acts referred to in 
this  paragraph  and  in  paragraph  2  of  this  Article,  and  with  the  Foresight  Panel 
referred  to  in  Article  37,  regarding  the  design  and  the  implementation  of  the 
regulatory sandbox.  

Where a regulatory sandbox is established at Union level for a health biotechnology 
product  in  accordance  with  Regulation  (EU)  …/…  [reference  to  be  added  after 
adoption  cf.  COM(2023)  193  final]  or  with  Article  [40]  of  this  Regulation,  the 
Commission or the Agency shall consult, where appropriate and in accordance with 
the legislative acts  referred to  in  this  paragraph, the Agency, the SCB, the MDCG, 
and  the  Foresight  Panel  referred  to  in  Article  37,  regarding  the  design  and  the 
implementation of the regulatory sandbox.  

The authorities responsible, pursuant to the applicable legislative act, for setting up a 
regulatory sandbox referred to in paragraphs 1 and 2 of this Article, shall ensure that 
due  consideration  is  given  to  the  regulatory  challenges  posed  by  combination 
products, and to consultations with the relevant  authorities with expertise regarding 
the associated parts of such products. 

For the purposes of the consultations referred to in paragraphs 1 and 2 of this Article, 
all authorities shall endeavour to provide their contribution swiftly, without prejudice 

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to  time  limits  set  out  in  the  provisions  of  the  Union  legislative  acts  in  the  area  of 
health governing the regulatory sandbox referred to in those paragraphs.  

5. 

The Commission, the Agency, the MDCG and the SCB shall, through the Foresight 
Panel,  facilitate  the  exchange  of  views  and  experiences  among  the  authorities 
responsible  for  the  setting  up  and  the  operation  of  regulatory  sandboxes  for  health 
biotechnology products. Those exchanges shall include the following: 

(a) 

(b) 

promoting  knowledge  sharing,  by  facilitating  the  exchange  of  information, 
regulatory  approaches, 
experiences  and  best  practices, 
technological  challenges, and emerging scientific insights  and the  appropriate 
regulatory responses (cross-framework knowledge sharing); 

including  on 

identifying potential implications for the evolution or adaptation of the relevant 
Union  legislative  acts  in  the  area  of  health  (cross-framework  regulatory 
learning).  

Article 40 

Regulatory sandboxes for novel health biotechnology products not falling under other 
regulatory sandboxes in Union legislation in the area of health 

1. 

Upon  a  substantiated  request  from  developers,  the  Commission  may  set  up  a 
regulatory sandbox that provides a controlled regulatory environment for the testing 
and development of a health biotechnology product, that: 

(a) 

cannot  be  appropriately  accommodated  in  any  of  the  regulatory  sandboxes 
available under the Union legislation in the area of health referred to in Article 
39, paragraphs (1) and (2); and  

(b)  whose  development  is  hindered  by  the  challenge  to  identify  a  suitable 

regulatory procedure in the area of health.  

A regulatory sandbox shall not be set up for health biotechnology products which are 
likely to fall under the scope of the Union legislation in the area of health referred to 
in Article 39, paragraphs (1) and (2).  

The sandbox shall be set up in accordance with this Article.  

2. 

3. 

Such  regulatory  sandbox  shall  set  out  a  time  limited  framework  to  allow  for  the 
generation of evidence and data, in a real-world environment and under supervision 
of one or more competent authorities. 

Developers wishing to participate in a regulatory sandbox referred to in paragraph 1 
shall  submit  a  substantiated  application  to  the  Commission.  That  application  shall 
include the following: 

(a) 

a  justification  for  the  establishment  of  a  regulatory  sandbox,  including  a 
description  of  the  product  in  question,  its  level  of  development,  and  a 
justification  with  regard  to  the  impossibility  of  appropriately  accommodating 
the  proposed  sandbox  in  any  of  the  regulatory  sandboxes  available  under  the 
Union legislation in the area of health referred to in Article 39, paragraphs (1) 
and (2).  

(b) 

the identification of existing regulatory challenges; 

(c) 

the  assessment  of  potential  benefits  and  potential  risks  of  the  health 
biotechnology product to be tested or developed.  

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4. 

5. 

6. 

7. 

8. 

9. 

Where the Commission concludes, on the basis of its assessment, that the application 
shall be accepted, it shall take a decision regarding the establishment of a regulatory 
sandbox,  by  means  of  an  implementing  act,  in  accordance  with  the  examination 
procedure  referred  to  in  Article  65(2).  That  implementing  act  shall  set  out  the 
duration  of  the  regulatory  sandbox  and  the  principles  for  operating  the  regulatory 
sandbox. 

The testing and development activities within the regulatory sandbox shall take place 
in  accordance  with  a  sandbox  plan  developed  and  updated  as  appropriate  by  the 
Commission  based  on  the  principles  referred  in  paragraph  4  of  this  Article.  The 
regulatory sandbox plan shall: 

(a) 

set  out  the  objectives,  the  specific  innovations  to  be  tested  in  the  regulatory 
sandbox, the relevant activities to be carried out within the regulatory sandbox, 
the geographical and temporal scope of those activities, as well as the relevant 
conditions and requirements thereof; 

(b)  be informed by data provided by, and consultations with, the developer of the 

health biotechnology product concerned; 

(c) 

(d) 

(e) 

identify the participants in the regulatory sandbox and their respective roles;  

include appropriate measures to mitigate potential risks, in particular to health 
and to the environment; 

include conditions regarding the suspension or the termination of the regulatory 
sandbox; 

(f) 

set out the supervision measures and the related responsibilities. 

When  assessing  the  applications  received  in  accordance  with  paragraph  3  of  this 
Article  and  when  developing  and  implementing  the  sandbox  plan,  the  Commission 
may consult the Agency, the SCB, the MDCG, or the Foresight Panel, as appropriate. 

Participants in the regulatory sandbox, in particular the developer, shall remain liable 
under applicable national legislation for any harm inflicted on third parties as a result 
of the testing taking place in the sandbox. They shall inform the Commission without 
undue delay of any information which might entail the amendment of the regulatory 
sandbox or concerns the quality, safety or efficacy of products developed as part of a 
regulatory sandbox. 

The  regulatory  sandboxes  shall  not  affect  the  supervisory  and  corrective  powers  of 
the competent authorities. In case of identification of risks to public health or safety 
concerns  associated  with  the  use  of  products  covered  by  a  sandbox,  competent 
authorities  shall  take  immediate  and  adequate  temporary  measures  in  order  to 
suspend  or  restrict  their  use  and  inform  the  Commission.  Where  such  mitigation  is 
not possible or proves to be ineffective, the development and testing process shall be 
suspended without delay until an effective mitigation takes place. 

When concluding the regulatory sandbox, the Commission shall, at the request of a 
developer and after having consulted the bodies referred to  in  paragraph [6] of this 
Article,  deliver  a  recommendation  on  an  existing  appropriate  regulatory  procedural 
pathway  for  authorising  the  placing  on  the  market  and  post-marketing  surveillance 
and vigilance of the products concerned.  

10. 

When a product is submitted for authorisation following a recommendation delivered 
in accordance with paragraph 9 of this  Article, due consideration by the authorities 

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11. 

12. 

1. 

(a) 

(b) 

(c) 

responsible for the assessment of the application  for authorisation shall be given to 
data and evidence collected in the regulatory sandbox. 

The Commission,  after consulting  competent  authorities of the Member  States,  and 
after seeking the opinion of the bodies consulted in accordance with paragraph [6] of 
this Article, may publish a report on the lessons learned from the regulatory sandbox 
and, where appropriate, conclusions regarding possible measures at  Union level for 
the  regulation  of  the  health  biotechnology  product  or  similar  innovation  categories 
concerned by the regulatory sandbox. 

The Commission may, by means of implementing acts, lay down common principles, 
criteria and practical arrangements for the assessment of applications received from 
developers and for the establishment and supervision of the regulatory sandboxes and 
for  sandbox  plans  referred  to  in  this  article.  These  implementing  acts  shall  be 
adopted in accordance with the examination procedure referred to in Article 65(2). 

CHAPTER VIII 

BIODEFENCE AND PREVENTING BIOTECHNOLOGY MISUSE 

SECTION 1 

UNION BIODEFENCE AND BIOSECURITY 

Article 41 

EU biothreat radar high impact health biotechnology strategic projects 

To  enable  access  to  the  support  measures  laid  down  in  Section  2  of  Chapter  II,  the 
Commission  shall  recognise  projects  located  in  the  Union  as  high-impact  health 
biotechnology  strategic  projects  contributing  to  the  EU  Biothreat  Radar  for  the 
detection,  characterisation,  identification,  analysis  and  assessment  of  biological 
threats,  including  novel,  unknown  and  engineered  pathogens  to  ensure  pathogen-
agnostic cross-border surveillance and early threat detection, as well as the generation 
and sharing of data required for this, only where they comply with the conditions laid 
down  in  Article  4[(1)]  and  make  a  substantial  contribution  to  at  least  one  of  the 
following: 

detection,  characterisation,  identification,  analysis  and  assessment  of  biological 
threats, including novel, unknown and engineered pathogens;  

interoperable  and  pathogen-agnostic  cross-border  surveillance,  as  well  as  the 
generation and sharing of data required for such surveillance;  

building sampling and detection infrastructure for early detection of novel pathogens 
and situational awareness across environmental and clinical sources, including basic 
logistics  for  collection  and  transport,  and  support  for  the  deployment  of  advanced 
detection methods, such as metagenomic sequencing; 

(d) 

ensuring the appropriate use of internationally recognised pathogen data standards; 

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(e) 

2.  

1. 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

ensuring that sequencing data generated through early detection activities is shared in 
a timely manner through the European Nucleotide Archive (ENA)70, to enable access 
and use by actors across the Union for the development, validation and deployment 
of  advanced  pathogen  detection  and  characterisation  methods,  by  engaging  in 
partnerships  among  industry,  academia,  public  authorities  and  defence  actors  to 
ensure data sharing and integration of warning systems. 

The provisions of this Regulation regarding the application for, and the recognition 
of,  high-impact  health  biotechnology  strategic  projects  laid  down  in  Articles  8  and 
10, respectively, apply to projects referred to in this Article. 

Article 42 

Biodefence capability high impact strategic project   

To  enable  access  to  the  support  measures  laid  down  in  Section  2  of  Chapter  II,  the 
Commission  shall  recognise  projects  located  in  the  Union  as  high  impact  health 
biotechnology  strategic  projects  for  biodefence  capability  only  where  they  comply 
with the conditions laid down in Article 4(1) and make a substantial contribution to at 
least one of the following: 

preventing or mitigating misuse of biotechnologies;  

rapid  surge  capacity  for  safe  sampling,  testing  sequencing  and  swift  manufacturing 
of rapid diagnostics;  

analysis  and  assessment  capacity  of  testing  and  sequencing  data  that  can  be 
mobilised across Member States;  

robust  pathogen-agnostic  pharmaceutical  and  non-pharmaceutical  defences  against 
biological threats; 

development,  validation  and  benchmarking  of  methods  for  the  detection  and 
attribution of genetic engineering, including the creation of open genetic engineering 
detection tools;  

testing  or  demonstration 

civilian  and  defence  research, 
infrastructures  for 
biotechnology  activities  relevant  to  defence,  security  and  resilience,  provided  that 
governance  ensures  clear  separation  of  mandates  and  access  regimes,  with 
appropriate  confidentiality  and  security  safeguards, 
relevant 
requirements  arising  from  the  Convention  on  the  Prohibition  of  the  Development, 
Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and 
on their Destruction (‘BTWC’), Union and national law.  

line  with 

in 

2. 

The provisions of this Regulation regarding the application for, and the recognition 
of,  high-impact  health  biotechnology  strategic  projects  laid  down  in  Articles  8  and 
10, respectively, apply to projects referred to in this Article. 

70 

ENA, https://www.ebi.ac.uk/ena. 

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SECTION 2 

PREVENTION OF BIOTECHNOLOGY MISUSE 

Article 43 

Biotechnology products of concern 

1. 

2. 

1. 

2. 

Biotechnology  products  of  concern  in  Annex  I  shall  only  be  made  available  to, 
introduced,  or  used  by  any  natural  or  legal  person  in  the  Union,  as  well  as  made 
available to any natural or legal person outside the Union, that has a legitimate need 
for those products, in accordance with this Section. 

The Commission is empowered to adopt delegated acts in accordance with Article 64 
(2) to amend Annex I by adding, removing or modifying categories of biotechnology 
products  of  concern,  setting  or  adjusting  thresholds  or  exclusions,  and  specifying 
technical  parameters,  in  order  to  reflect  developments  in  scientific  evidence, 
biosecurity  and  biosafety  risks  or  patterns  of  misuse,  also  considering  the  latest 
developments under relevant international fora and instruments. 

Article 44 

Verification of legitimate need 

An economic operator that makes available on the Union market, including through 
online marketplaces, biotechnology products of concern, shall, for each transaction, 
verify proof of identity of the prospective customer, record the transaction, including 
the quantities ordered, and assess whether the customer has a legitimate need. 

For  the  purposes  of  conducting  the  verification  referred  to  in  paragraph  1,  the 
economic  operator  shall  request  the  following  information  from  the  prospective 
customer prior to facilitating the exchange: 

(a) 

proof of identity of the person; 

(b) 

institutional or corporate affiliation; 

(c) 

documentation  establishing  the  legitimacy  of  the  institution  or  corporation, 
such as address, any official registration number, evidence of legal personality 
and  of  a  purpose,  and,  where  applicable,  evidence  of  authorisations, 
certifications or biosafety approvals appropriate to the intended use;  

(d) 

information on the intended use of the product.  

The first  subparagraph,  with  the exception of transaction recording, shall not  apply 
where the economic operator has conducted an equivalent verification for the same 
customer  within  the  preceding  five  years  and  the  new  transaction  does  not 
significantly deviate in nature or scale from previous transactions. 

3. 

When  assessing  legitimate  need,  the  economic  operator  shall  take  into  account  all 
relevant circumstances, in particular, as applicable: 

(a) 

the  demonstrable  need  for  the  biotechnology  product  of  concern  and  the 
legitimacy of its intended use; 

(b) 

the background of the applicant; 

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(c) 

(d) 

(e) 

the  applicant’s  compliance  history  with  the  economic  operator  and,  where 
available, with other operators, including past incidents or refused orders; 

credentials that demonstrate evidence of the legitimate need, including relevant 
academic publications, history or track record in a related domain; 

documentation  establishing  the  existence  of  suitable  facilities,  competencies 
and biosafety arrangements appropriate to the intended use. 

The economic operator shall refuse to  make the  biotechnology  products  of concern 
available in the case of a suspicious transaction. 

The economic operator shall report to the national contact point referred to in Article 
46(3) any suspicious transaction, or attempted suspicious transaction, in accordance 
with Article 46(5). 

Economic  operators  shall  keep  and  retain  records  of  the  transactions  referred  to  in 
this Article for three years and shall make them available without undue delay to the 
competent authorities upon request. 

Paragraphs  1  to  7  shall  also  apply  by  analogy  to  persons  that  are  not  economic 
operators, except in the case where the biotechnology product of concern is supplied 
to a person that is employed by the same legal entity.  

4. 

5. 

6. 

7. 

Article 45 

Benchtop equipment 

Benchtop  nucleic  acid  synthesis  devices  made  available  in  the  Union  shall  contain  a 
mechanism to screen for sequences of concern as defined in Annex I, provided that databases 
of sequences of concern are not stored on the equipment itself, in an unencrypted manner or a 
manner that could allow users to extract the database.  

Article 46 

Prevention and reporting of biotechnology misuse 

1. 

For  the  purpose  of  preventing  and  detecting  biotechnology  misuse,  economic 
operators and online marketplaces shall report suspicious transactions, having regard 
to all circumstances and in particular where the prospective customer: 

(a) 

is  not  clear  about  their  identity  or  affiliations,  or  provides  information  that 
inconsistent  addresses  or 
cannot  be  confirmed  or  verified, 
unverifiable company details; 

including 

(b)  would  not  be  expected,  in  the  normal  course  of  business,  to  place  such  an 
life  science  research  or 
is  no 
order, 
biotechnology,  or  no  plausible  requirement  for  biotechnology  products  of 
concern; 

including  where 

there 

link 

to 

(c) 

(d) 

proposes  an  intended  use  that  does  not  match  their  reported  job  role  or 
institutional affiliation; 

requests  unusual  labelling  or  shipping  procedures,  including  misidentification 
of  goods  on  packaging  or  changes  to  the  recipient’s  name  after  the  order  has 
been placed but before shipment; 

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(e) 

(f) 

proposes  unusual  methods  of  payment,  including  cash  for  high-value  items, 
personal credit cards for institutional purchases, or payment through non-bank 
third  parties,  or  offers  unusually  favourable  terms  including  above  market 
prices; 

requests unusual confidentiality conditions regarding the order, including with 
respect  to  their  identity,  the  final  destination  or  the  destruction  of  transaction 
records; 

(g) 

requests delivery to an address without a legitimate biotechnology business or 
research justification, including a residential address. 

Economic operators and online marketplaces shall have appropriate, reasonable and 
proportionate  procedures  in  place  to  detect  suspicious  transactions,  adapted  to  the 
specific  environment  in  which  biotechnology  products  of  concern  are  made 
available. 

Each  Member  State  shall  set  up  at  least  one  national  contact  point  with  clearly 
identified  contact  details,  web  form  or  other  effective  tool  for  the  reporting  of 
suspicious transactions of biotechnology products of concern. The contact point shall 
be part of or have direct links to law enforcement and national inspection authorities. 

Economic  operators  and  online  marketplaces  shall  refuse  a  suspicious  transaction. 
They  shall  report  any  suspicious  transaction  or  attempted  suspicious  transaction 
within  24  hours  of  determining  that  it  is  suspicious.  Reports  shall  include,  where 
possible,  the  identity  of  the  prospective  customer  and  the  facts  that  led  to  the 
suspicion  and  shall  be  addressed  to  the  national  contact  point  of  the  Member  State 
where the transaction was concluded or attempted. 

Where  a  biotechnology  product  of  concern  falls  also  under  categories  regulated 
under other EU legislation, to  avoid  duplication  of reporting, where the transaction 
for that biotechnology product of concern has already been reported as a suspicious 
transaction  under  one  legal  framework,  it  shall  not  be  reported  again.  Where  in 
doubt,  its  intended  use  should  be  prioritised  for  reporting  obligations,  pursuant  to 
Regulation (EU) 2021/821[71] and Regulation (EU) 2019/1148[72]. 

Article 47 

Training and awareness-raising 

Member States shall ensure adequate resources for, and the provision of, training for 
law  enforcement  authorities,  first  responders  and  customs  authorities  to  recognise 
biotechnology products of concern and to react in a timely and appropriate manner to 
suspicious activity.  

Regulation (EU) 2021/821 of the European Parliament and of the Council of 20 May 2021 setting up a 
Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use 
items, OJ L 206, 11.6.2021, pp. 1–461. ELI: http://data.europa.eu/eli/reg/2021/821/oj. 
Regulation  (EU)  2019/1148  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on  the 
marketing  and  use  of  explosives  precursors,  amending  Regulation  (EC)  No  1907/2006  and  repealing 
Regulation  (EU)  No  98/2013  (Text  with  EEA  relevance),  OJ  L  186,  11.7.2019,  pp.  1–20. 
ELI: http://data.europa.eu/eli/reg/2019/1148/oj. 

2. 

3. 

4. 

5. 

1. 

71 

72 

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2. 

3. 

4. 

1. 

2. 

3. 

4. 

Member  States  shall  organise  awareness-raising  actions,  including  on  the  issue  of 
insider  threats,  adapted  to  the  specificities  of  each  sector  that  uses  biotechnology 
products of concern.  

To  facilitate  cooperation  and  effective  implementation,  and  avoid  duplicate 
reporting, Member States shall organise regular exchanges between law enforcement 
authorities, national supervisory authorities, economic operators, online marketplaces 
and representatives of sectors that use biotechnology products of concern.  

Economic  operators  shall  inform  their  personnel  about  the  conditions  under  which 
biotechnology products of concern may be made available and shall raise personnel’s 
awareness accordingly. 

Article 48 

National inspection authorities 

Each  Member  State  shall  designate  a  competent  authority  responsible  for  the 
inspection and control of compliance with the obligations laid down in this Section. 

Member  States  shall  ensure  that  the  national  inspection  authority  has  the  resources 
and  investigative  powers  necessary  to  perform  their  tasks,  including  the  power  to 
request  information  and  records,  to  carry  out  on-site  inspections  and,  where 
appropriate, to conduct test purchases, including online. 

Member  States  shall  ensure  that  the  national  inspection  authorities  regularly  run 
simulation  exercises  to  test  the  procedures  in  place  and  to  ensure  appropriate 
response to incidents. 

Member  States  shall  ensure  the  participation  of  national  inspection  authorities,  as 
appropriate,  in  the  relevant  activities  of  the  Steering  Group,  in  particular  for  the 
exchange  of  information  on  implementation  practices,  inspection  findings  and 
emerging risks.Member States shall ensure risk-based audits of economic operators, 
verifying, in particular, the existence and effectiveness of screening mechanisms for 
legitimate need, record-keeping as provided for in Article [44][(6)] and detection of 
suspicious transactions and incidents, and response procedures. 

Article 49 

Commission enforcement support and monitoring 

The Commission may support and monitor national competent authorities in the enforcement 
of  this  section,  by  taking  actions  such  as  requesting  information  and  records  and  running 
training exercises. 

Article 50 

Audits 

Member States shall ensure risk-based audits of economic operators, verifying, in particular, 
the existence and effectiveness of screening mechanisms for legitimate need, record-keeping 
as provided for in Article 44[(6)] and detection of suspicious transactions and incidents, and 
response procedures. 

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Article 51 

Penalties 

1. 

2. 

3. 

1. 

2. 

Member States shall lay down the rules on penalties applicable to  infringements  of 
this  Section  and  shall  take  all  measures  necessary  to  ensure  that  they  are 
implemented.  The  penalties  provided  for  shall  be  effective,  proportionate  and 
dissuasive. 

Member States may impose fines on economic operators not exceeding 5% of their 
annual total worldwide turnover in the preceding financial year when Member States 
finds that the provider intentionally or negligently infringed the relevant  provisions 
of this Section. 

In fixing the amount of the fine or periodic penalty payment, regard shall be had to 
the  nature,  gravity  and  duration  of  the  infringement,  taking  due  account  of  the 
principles of proportionality and appropriateness. 

Article 52 

Advisory group on biosecurity 

An Advisory Group on Biosecurity (‘the Advisory Group’) is hereby established. 

The Advisory Group shall provide independent scientific advice to the Commission 
on biosecurity risks arising from the rapid development of biotechnology, including 
from  AI  models  as  described  in  Regulation  (EU)  2024/1689  in  biological 
applications (‘AI models in biological applications’). It shall be selected and operate 
in accordance with the Commission’s framework for expert groups73.  

3. 

The tasks of the Advisory Group shall include: 

(a)  monitoring advances in biotechnology to advise the Commission on emerging 
biosecurity  challenges,  including  on  any  potentially  necessary  updates  to  the 
list  of  biotechnology  products  of  concern  laid  down  in  Annex  I  and  on  risk-
based audits of economic operators; 

(b)  monitoring  the  capabilities  and  risk  profile  of  AI  models  in  biological 

applications throughout their life cycle; 

(c) 

(d) 

contributing  to  the  preparation  of  Union  guidance  and  best  practices  for 
responsible innovation on AI models in biological applications; 

facilitate  dialogue  and  coordination  among  scientific,  industry,  and  security 
stakeholders  and  support,  where  appropriate,  international  cooperation  on 
biosecurity. 

4. 

Where the Advisory Group has reasonable grounds to suspect that an AI model in a 
biological  application  not  covered  by  Regulation  (EU)  2024/1689,  poses  biological 
systemic risk, it  shall  issue a qualified  alert  to  the Commission  and to  the Member 
States. A qualified alert may be issued following a decision of the Advisory Group or 
at the initiative of at least 50% of its members. The alert shall be concise and duly 

73 
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5. 

6. 

7. 

8. 

1. 

2. 

reasoned and shall indicate at least the point of contact of the developer of the model 
concerned and the factual basis for the alert.  

Where  the  Advisory  Group  has  reasonable  grounds  to  suspect  that  an  AI  model 
covered by Regulation (EU) 2024/1689 poses biological systemic risk, it shall inform 
the scientific panel of independent experts referred to in Article 68 Regulation (EU) 
2024/1689. That panel may issue a qualified alert to the AI Office in accordance with 
Regulation (EU) 2019/1689. 

The  Advisory  Group  shall  be  composed  of  up  to  25  globally  leading  independent 
experts  appointed  by  the  Commission  based  on  their  recognized  expertise  in  the 
areas of biotechnology, biosecurity, biodefence and AI.  

The members of the Advisory Group shall perform their tasks with impartiality and 
objectivity.  The  Advisory  Group  shall  liaise,  where  appropriate,  with  other  Union 
and  international  expert  structures  addressing  biotechnology,  AI,  or  biosecurity  to 
ensure coherence and efficiency, including the scientific panel referred to in Article 
68 of Regulation (EU) 2024/1689. 

The Advisory Group may adopt opinions, recommendations, or principles on matters 
within its mandate. 

Article 53 

Biological systemic risk  

The Commission shall monitor biological systemic risk from AI models in biological 
applications  and  propose  mitigating  actions,  based  on  advice  provided  by  the 
Advisory  Group  and  in  line  with  the  Union  harmonisation  legislation  on  AI, 
including boosting biodefence capabilities or regulation, including on assessment and 
mitigation of systemic risk from those AI models, as appropriate. 

Where  a  qualified  alert  is  issued  by  the  Advisory  Group  as  referred  to  in  Article 
52(3),  point  (d),  the  Commission  and  the  Member  States  shall  take  appropriate 
measures to ensure a proper control of risks. 

Article 54 

Monitoring and guidance 

The  Commission,  based  on  advice  by  the  Advisory  Group  on  Biosecurity,  and  where 
appropriate, in cooperation with the Steering Group, may issue and regularly update guidance, 
to assist actors in the supply chain and the competent authorities. The guidance may provide: 

(a) 

(b) 

(c) 

(d) 

clarifications regarding the biotechnology products of concern listed in the Annex I; 

clarification  on  the  criteria  for  determining  the  sequences  of  concern  referred  to  in 
Annex I; 

information  and  methodologies  for  the  assessment  of  legitimate  need  for  the 
purposes of this Section; 

information on how to exchange relevant information between competent authorities, 
national contact points and among Member States; 

(e) 

information on how to recognise, refuse, and report suspicious transactions; 

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(f) 

(g) 

(h) 

(i) 

obligations  for  natural  or  legal  persons  that  are  not  economic  operators  that  make 
available biotechnology products of concern; 

requirements  regarding  benchtop  nucleic  acid  synthesis  equipment  referred  to  in 
Article 45; 

information on risk-based audits of economic operators referred to in Article 50; 

any other information deemed useful for effective implementation, including on the 
investigative  powers  of  national  inspection  authorities,  test  purchases,  information 
requests from, and resources of, such authorities, or requested by relevant economic 
operators. 

Article 55 

Coordination on biosecurity and biosafety 

The  Steering  Group  referred  to  in  Article  20  shall  facilitate  the  coordination  of  and 
information  exchange  on  the  enforcement  of  the  provisions  in  this  section  among  Member 
States. 

CHAPTER IX 

AMENDMENTS TO REGULATIONS (EC) No 178/2002, (EC) No 1394/2007, (EU) No 
536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 

Article 56 

Amendments to Regulation (EC) No 178/2002  

Regulation (EC) No 178/2002 is amended as follows: 

(1) 

in Article 3, the following points 19, 20 and 21 are added:  

‘19.  ‘regulatory  sandbox’  means  a  controlled  environment  where  participants  can 
test innovative products or substances and related processes as well as data and 
other regulatory requirements at a pre-market stage under a set of defined rules 
and monitoring and for a limited period of time;  

20. 

21. 

‘regulatory sandbox plan’ means a plan setting out the scope, the requirements 
and the conditions governing the operation of a specific regulatory sandbox;  

‘participants’  means  any  natural  or  legal  person  participating  in  a  regulatory 
sandbox  to  whom  specific  tasks  are  assigned  in  the  regulatory  sandbox  plan, 
such  as  business  operators,  Union  and  national  agencies,  final  consumers, 
academia and research institutions.’;  

(2) 

in Article 22(5), point (a) is replaced by the following:  

‘(a)  scientific advice and scientific and technical support on human nutrition;’  

(3) 

Article 28 is amended as follows: 

(a) 

paragraph 3 is replaced by the following: 

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‘3.  The Scientific  Committee shall be composed of the  first Vice-Chairs  of 
the  Scientific  Panels  and  six  independent  scientific  experts  who  do  not 
belong to any of the Scientific Panels.’ 

(b)  paragraph 6 is replaced by the following: 

‘6.  The  Scientific  Committee  and  the  Scientific  Panels  shall  be  chaired  by 
the  staff  of  the  Authority  without  the  right  to  vote.  The  Scientific 
Committee and the Scientific Panels  shall each  choose two Vice-Chairs 
from among their members.’ 

(c) 

in paragraph 9, the following point (h) is added: 

‘(h) 

the role of the Authority when chairing the Scientific Committee and the 
Scientific Panels.’ 

(4) 

in Article 32a, paragraph 1 is replaced by the following:  

‘1.  Where Union law contains provisions for the Authority to provide a scientific 
output,  including  a  scientific  opinion,  the  Authority  shall,  at  the  request  of  a 
potential applicant or notifier, provide advice on the content of the application 
or notification, prior to its submission, including the rules applicable to and the 
required  content    thereof  as  well  as  on  the  design  of  the  studies  and  testing 
strategies to support such an application or notification. Such advice provided 
by  the  Authority  shall  be  without  prejudice  and  non-committal  as  to  any 
subsequent assessment of applications or notifications by the Scientific Panels.’ 

(5) 

Article 32b is amended as follows: 

(a) 

in paragraph 4, the third subparagraph is replaced by the following: 

‘The  assessment  of  the  validity  or  the  admissibility  of  such  re-submitted 
application  or  notification  shall  commence  three  months  after  the  date  of  re-
submission  of  the  application  and  provided  that  a  notification  of  the  studies 
pursuant to the second subparagraph has taken place.’ 

(b) 

in paragraph 5, the third subparagraph is replaced by the following: 

‘The  assessment  of  the  validity  or  admissibility  of  such  re-submitted 
application  or  notification  shall  commence  three  months  after  the  date  of  re-
submission of the application and provided that all studies that had previously 
been  notified  in  accordance  with  paragraph  2  or  3  are  included  in  the 
resubmitted application or notification.’;  

(c) 

paragraph 6 is replaced by the following: 

‘6.  Where  the  Authority  detects,  during  its  risk  assessment,  that  studies 
notified  in  accordance  with  paragraph  2  or  3  are  not  included  in  the 
corresponding application or notification in full, and in the absence of a 
valid justification of the applicant or notifier to that effect, the applicable 
time limits within which the Authority is required to deliver its scientific 
output shall be suspended. That suspension shall end three months after 
the submission of all data of those studies.’ 

(6) 

(7) 

in Article 32c, paragraph 1 is deleted. 

the following Chapter IIIA is inserted: 

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‘CHAPTER IIIA  

REGULATORY SANDBOXES 

Article 49a 

General provisions on regulatory sandboxes 

1.  A  Member  State  or  several  Member  States  jointly  may  establish  regulatory 
sandboxes in accordance with this Article and the procedure set out in Article 
49b. 

2. 

Regulatory sandboxes may be established in relation to the following: 

(a) 

all stages of the production, processing and distribution of food with the 
exception  of  novel  foods,  and  also  of  the  feed  produced  for,  or  fed  to 
food-producing animals;  

(b) 

food contact materials, with the exception of plastic recycled materials;   

(c) 

products,  other  than  food  and  feed,  containing  or  consisting  of 
genetically  modified  organisms  as  defined  in  Article  2,  point  (2),  of 
Directive 2001/18/EC.  

The  making  available  of  products  within  a  regulatory  sandbox  shall  not  be 
regarded as placing on the market. 

3. 

Regulatory sandboxes shall pursue one or more of the following objectives: 

(a) 

(b) 

(c) 

facilitating  the  development,  testing  and  validation  of  technologies, 
products and substances before they obtain authorisation or approval for 
placing on the market, where so required by Union law; 

testing  data  requirements,  including  the  type  and  design  of  studies 
required for conducting a safety and/or efficacy assessment;  

regulatory 

testing  alternative 
their 
performance as regards the attainment of the objectives of the applicable 
Union  sectoral  law  in  comparison  to  the  existing  requirements;  in  the 
areas where Union law provides for an approval or authorisation, as well 
as in the area of food information to consumers.  

requirements  and  appraising 

4.  Member  States  shall  monitor  and  supervise  the  operation  of  regulatory 
sandboxes  that  they  establish  and  ensure  compliance  with  the  regulatory 
sandbox plan. 

5.  A  participant  to  an  established  regulatory  sandbox  shall  immediately  inform 
the  competent  authorities  of  the  Member  State(s)  concerned  if  it  considers  or 
has  reason  to  believe  that  the  conditions  of  the  regulatory  sandbox  plan  have 
not been complied with and/or there are potential risks to public health, animal 
health  or  welfare,  plant  health  or  to  the  environment,  which  may  require  the 
revocation  of  the  regulatory  sandbox  or  the  amendment  of  the  regulatory 
sandbox  plan  to  provide  for  mitigating  measures.  Participants  shall  also 
immediately  inform  the  competent  authorities  of  any  other  information  that 
concerns  the  quality,  safety  or  efficacy  of  the  subject  matter  of  the  relevant 
regulatory sandbox. 

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6.  Member  States  shall  immediately  notify  to  the  Commission  and,  where 
relevant,  to  the  Authority  any  violation  of  the  conditions  set  out  in  the 
regulatory  sandbox  plan  and/or  the  identification  of  any  potential  risks  to 
public health, animal health or welfare, plant health or to the environment. 

7.  Member  States  shall  suspend  or  revoke  a  regulatory  sandbox  at  any  time  on 
their  own  motion,  or  at  the  request  of  the  Commission  in  accordance  with 
paragraph 9, in either of the following cases: 

(a) 

the  requirements  and  conditions  governing  the  regulatory  sandbox  plan 
are not met;  

(b)  where necessary to protect public health, animal health or welfare, plant 
health  or  the  environment  and  there  is  no  possibility  for  effective 
mitigation measures. 

Member  States  shall  inform  the  Commission,  the  Authority  and  the  other 
Member  States  without  delay  of  the  suspension  or  revocation  of  a  regulatory 
sandbox and of the reasons. 

8.  Where after the setting up of a regulatory sandbox in their territory, a Member 
State  identifies  risks  to  public  health,  animal  health  and  welfare,  plant  health 
and  to  the  environment  which  can  be  fully  mitigated  by  amendments  to  the 
regulatory  sandbox  plan,  it  shall  communicate  to  the  Commission,  the 
Authority  and  the  other  Member  States  the  draft  amendments  in  accordance 
with the procedure laid down in Article 49b.  

9.  Where the Commission considers that one of the cases referred to in paragraph 
7 is fulfilled, it shall immediately adopt implementing acts in accordance with 
the  procedure  referred  to  in  Article  58(2)  requesting  the  suspension  or  the 
revocation of the regulatory sandbox concerned.  

However,  in  emergencies,  the  Commission  may  provisionally  adopt  an 
implementing  act  requesting  the  suspension  of  the  regulatory  sandbox 
concerned  after  consulting  the  Member  State(s)  concerned  and  informing  the 
other Member States. As soon as possible, and at most within 10 working days, 
the measure taken shall be confirmed, amended or revoked in accordance with 
the procedure referred to in Article 58(2) and the reasons for the Commission’s 
decision shall be made public without delay.  

10.  A Member State may prolong the duration once of a regulatory sandbox for a 
limited  time  where  this  is  justified  by  the  need  to  attain  the  objective  of  the 
specific  regulatory  sandbox  at  hand  and  shall  inform  the  Commission,  the 
Authority and the other Member States thereof.  

11.  The  Commission  may,  by  means  of  implementing  acts,  specify  common 
principles  or  practical  arrangements  for  the  establishment  and  supervision  of 
regulatory  sandboxes,  including  the  establishment  of  sandboxes  involving 
several  Member  States  pursuant  to  this  Article,  Article  49b  and  49c.  Those 
implementing acts shall be adopted in accordance with the procedure referred 
to in Article 58(2).  

Article 49b 

Establishment of regulatory sandboxes  

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1.  Where a Member State deems it appropriate to establish a regulatory sandbox, 
it shall communicate to the Commission, the Authority and the other Member 
States  a  draft  regulatory  sandbox  plan,  which  shall  contain  the  following 
elements: 

(a) 

(b) 

the objectives of the regulatory sandbox;  

a description of the specific areas that the sandbox will cover, including 
the products or substances, processes, technologies and practices; 

(c) 

a clearly defined geographical scope; 

(d) 

a clearly defined and limited temporal scope; 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

the  regulatory  or  scientific  justifications  for  setting  up  the  regulatory 
sandbox; 

an  identification  of  the  relevant  provisions  of  Union  law  that  apply  for 
the purposes of the regulatory sandbox and those that do not apply or are 
adapted;  

the procedure for the application and selection for participants, including 
clearly defined eligibility criteria, the modalities governing the provision 
of  the  explicit  and  prior  consent  from  participating  final  consumers  as 
well  as  the  modalities  by  which  the  participants  may  end  their 
participation;  

the  possible  involvement  of  the  Authority,  other  Union  agencies  and 
national  agencies,  where  relevant,  provided  that  they  have  expressed 
interest to join the regulatory sandbox; 

the  activities  allowed  to  be  carried  out  and  the  conditions  and 
requirements that apply; 

an assessment that identifies how potential risks to public health, animal 
health or welfare, plant health or the environment are mitigated;  

(k)  details on how activities will be monitored, including responsibilities of 
the 

the  supervision  of 

the  competent  authorities  entrusted  with 
implementation of the sandbox plan. 

2.  Where  several  Member  States  deem  it  appropriate  to  jointly  establish 
regulatory  sandboxes,  they  shall  collectively  communicate  a  draft  regulatory 
sandbox plan to the Commission, the Authority and the other Member States. 
The regulatory sandbox plan shall specify the activities to take place in each of 
the participating Member States in addition to the elements listed in paragraph 
1. 

3.  Member States shall engage with relevant stakeholders during the preparation 
of  a  draft  regulatory  sandbox  plan  to  gather  diverse  perspectives  and  foster 
collaboration. 

4. 

The Member State(s) which deem it appropriate to set up a regulatory sandbox 
alone  or  jointly,  shall  communicate  the  draft  regulatory  sandbox  plan  to  the 
Commission, the Authority and other Member States at least 60 days prior to 
the  intended  commencement  of  the  sandbox  activities.  Member  State(s)  shall 
consider  any  feedback  or  recommendations  from  the  Commission,  the  other 

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Member  States  and  the  Authority  before  deciding  whether  to  establish  the 
regulatory sandbox.  

5.  Member State(s) shall communicate to the Commission, the Authority and the 
other  Member  States  any  subsequent  draft  amendment  to  regulatory  sandbox 
plans and the reasons thereof. Paragraphs 1 to 4 shall apply mutatis mutandis. 

Other responsibilities, monitoring and reporting obligations regarding regulatory 
sandboxes 

Article 49c 

1. 

2. 

Regulatory  sandboxes  shall  not  affect  the  enforcement  and  monitoring 
responsibilities of the competent  authorities set  out  in  Article 17 and in  other 
sectoral legislation.  

Participants,  with  the  exception  of  final  consumers,  in  particular  the  operator 
that is the developer of the product or substance concerned, shall remain liable 
under applicable national legislation for any harm inflicted on third parties as a 
result from the testing taking place in the sandbox. 

3.  Member  States  shall  submit  annual  reports  to  the  Commission  on  the  results 
from  the  implementation  of  regulatory  sandboxes,  including  good  practices 
developed,  lessons  learnt  and  recommendations  on  their  setup  and,  where 
relevant,  on  the  application  of  the  relevant  sectorial  Union  legislation.  Those 
reports shall be made publicly available by the Commission. 

4. 

The Authority shall also ensure the necessary revisions of its  guidance where 
relevant and appropriate on the basis of those annual reports. 

Article 57 

Amendments to Regulation (EC) No 1394/2007  

Regulation (EC) No 1394/2007 is amended as follows: 

(1) 

Article 2 is amended as follows: 

(i) 

in paragraph 1, the following point (e) is added: 

‘(e) 

‘viral  vector’  means  a  genetically  modified  virus  that  is  used  to  deliver 
genetic material into cells.’ 

(ii) 

the following paragraph 6 is added: 

‘6.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance 
with  Article  25a  to  amend  this  Regulation  in  order  to  amend  the 
definitions referred to in paragraph 1, regarding what constitutes a tissue 
engineered  product,  in  light  of  technical  and  scientific  advancements  in 
the  field  of  advance  therapy  medical  products  and  taking  into  account 
definitions agreed at Union and international level without extending the 
scope  of  this  definition.  The  delegated  acts  shall  be  adopted  after 
consultations  with  the  European  Medicines  Agency  and  the  SoHO 
Coordination Board.’; 

(2) 

The following Article 4a is inserted: 

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Advanced therapy investigational medicinal products containing or consisting of 

genetically modified organisms presenting no or negligible risks 

1. 

By  way  of  exemption  from  Article  5a  of  Regulation  (EU)  No  536/2014  [as 
added by the revised Regulation No (EC) 726/2004], sponsors of clinical trials 
that concern advanced therapy investigational medicinal products as defined in 
Article  2(7)  of  that  Regulation,  consisting  or  containing  GMOs,  are  not 
required to submit an environmental risk assessment, if those products belong 
to at least one of the following categories:  

(a) 

non-viable  or  replication  deficient  viral  vector  that  is  used  to  deliver  a 
genetic  sequence  of  human  origin,  and  the  vector  does  not  carry  an 
antimicrobial resistance gene; 

(b)  genetically  modified  somatic  cells,  that  cannot  secrete  or  produce 

infectious agents due to the genetic modification; 

(c) 

genetically modified bacteria that do not carry an antimicrobial resistance 
gene; 

(d)  genetic  material  altered  using  genome  editing  techniques  (ex  vivo  or  in 
vivo), provided that it has generally negligible adverse effects on human 
health and the environment. 

The  exemption  provided  for  in  paragraph  1  of  this  Article  is  subject  to  the 
sponsor  submitting,  through  the  EU  Portal  and  as  part  of  the  clinical  trial 
application  dossier,  a  reasoned  declaration  confirming  that  the  advanced 
investigational  therapy medicinal  product  concerned falls into one or more of 
the categories referred to in points (a) to (d) of paragraph 1, of this Article. The 
Committee  for  Medicinal  Products  for  Human  Use  (CHMP)  referred  to  in 
Article [148] of Regulation […] [revised Regulation No (EC) 726/2004] shall 
verify  this  declaration  and  the  reasons  provided,  and  the  CHMP  may,  to  this 
end,  access  the  information  on  the  clinical  trial  application  in  the  EU  portal.  
The CHMP shall communicate its opinion on the declaration to the sponsor and 
to the reporting Member State within 21 days after the submission date referred 
to  in Article  5(1)  of  Regulation  (EU)  No  536/2014  [as  revised  by  European 
Biotech Act].   

The  reporting  Member  State,  giving  due  consideration  to  the  opinion  of  the 
CHMP, shall assess if the conditions of paragraph 1 of this Article apply or if 
the  sponsor  is  to  be  requested  to  submit  an  environmental  risk  assessment 
pursuant to Article 5a of Regulation (EU) No 536/2014 [as introduced by the 
revised Regulation No (EC) 726/2004].  

Sponsors  of  clinical  trials  concerning  advanced  investigational  therapy 
medicinal products that fall under paragraph 1 of this Article are also exempted 
from complying with the GMO related requirements of Article 61(2), point (a), 
of Regulation (EU) No 536/2014 [as introduced by the revised Regulation No 
(EC)  726/2004]  regarding  the  authorisation  of  manufacturing  and  import  of 
advanced investigational therapy medicinal products.  

2. 

3. 

4. 

5. 

The exemptions provided for in this Article shall apply only for the duration of 
the clinical trial, limited to the activities within the clinical trial.’; 

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(3) 

Article 25a is replaced by the following:  

‘Article 25a 

Exercise of the delegation 

1. 

2. 

3. 

The power to adopt delegated acts is conferred on the  Commission subject to 
the conditions laid down in this Article. 

The  power  to  adopt  delegated  referred  to  in  Article  2,  paragraph  6,  and  in 
Article 24 shall be conferred on the Commission for a period of five years from 
[insert date xx, from the entry into force of this Regulation].  

The Commission shall draw up a report in respect of the delegation of power 
not  later  than  nine  months  before  the  end  of  the  five-year  period.  The 
delegation  of  power  shall  be  tacitly  extended  for  periods  of  an  identical 
duration,  unless  the  European  Parliament  or  the  Council  opposes  such 
extension not later than three months before the end of each period. 

The delegation of power referred to in Article 2, paragraph 6, and in Article 24 
may be revoked at any time by the European Parliament or by the Council. A 
decision to revoke shall put an end to the delegation of the power specified in 
that  decision.  It  shall  take  effect  the  day  following  the  publication  of  the 
decision  in  the  Official  Journal  of  the  European  Union  or  at  a  later  date 
specified therein. It shall not affect the validity of any delegated acts already in 
force. 

4. 

Before  adopting  a  delegated  act,  the  Commission  shall  consult  experts 
designated by each Member State in accordance with the principles laid down 
in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 

5.  As  soon  as  it  adopts  a  delegated  act,  the  Commission  shall  notify  it 

simultaneously to the European Parliament and to the Council. 

6.  A delegated act adopted pursuant to Article 2, paragraph 6, and Article 24 shall 
enter into force only if no objection has been expressed either by the European 
Parliament or by the Council within a period of two months of notification of 
that act to the European Parliament and the Council or if, before the expiry of 
that period, the European Parliament and the Council have both  informed the 
Commission  that  they  will  not  object.  That  period  shall  be  extended  by  two 
months at the initiative of the European Parliament or of the Council. 

Article 58 

Amendments to Regulation (EU) No 536/2014  

Regulation (EU) 536/2014 is amended as follows: 

(1) 

Article 2 is amended as follows: 

(a) 

point (3) is replaced by the following: 

‘(3)  ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of 

the following conditions: 

(a) 

the  investigational  medicinal  products,  excluding  placebos,  are 
authorised; 

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(b) 

(c) 

according  to  the  protocol  of  the  clinical  trial,  the  use  of  the 
investigational  medicinal product  is  evidence-based and supported 
by published scientific evidence on the safety and efficacy of those 
investigational medicinal products concerned; and 

the  additional  diagnostic  or  monitoring  procedures  do  not  pose 
more  than  minimal  additional  risk  or  burden  to  the  safety  of  the 
subjects compared to normal clinical practice in any Member State 
concerned;’ 

(b) 

the following point (3a) is inserted: 

‘(3a)  ‘Minimal-intervention clinical trial’ means a clinical trial which fulfils all 

of the following conditions: 

(a) 

(b) 

(c) 

the investigational medicinal products are authorised; 

according  to  the  protocol  of  the  clinical  trial,  the  investigational 
medicinal  products  are  used  in  accordance  with  the  terms  of 
marketing authorisation; and 

the  additional  diagnostic  or  monitoring  procedures  do  not  pose 
more  than  minimal  additional  risk  or  burden  to  the  safety  of  the 
subjects compared to normal clinical practice in any Member State 
concerned’; 

(c) 

points 12 and 13 are replaced by the following: 

‘(12)  ‘Member State concerned’ means the Member State where an application 
for  authorisation  of  a  clinical  trial  or  a  combined  study  of  a  substantial 
modification  has  been  submitted  under  Chapters  II,  IIa  or  III  of  this 
Regulation respectively;” 

'(13)  ‘Substantial modification’ means any change to any aspect of the clinical 
trial  which  is  made  after  the  notification  of  a  decision  referred  to  in 
Article 8 in at least one Member State concerned and which is likely to 
have a substantial impact on the safety or rights of the subject or on the 
reliability and robustness of data generated in the clinical trial;’ 

(d) 

the following point (13a) is inserted: 

‘(13a)  ‘Parallel substantial modification’ means a substantial modification for 
which an application is submitted to a Member State concerned before a 
decision  on  a  previous  application  for  a  substantial  modification  to  the 
same clinical trial is notified by that Member State to the sponsor;’ 

(e) 

point (21) is replaced by the following: 

‘(21)  ‘Informed  consent’  means  a  subject’s  free  and  voluntary  expression  of 
his  or  her  willingness  to  participate  in  a  particular  clinical  trial,  after 
having been informed of all aspects of the clinical trial that are relevant 
to  the  subject’s  decision  to  participate  or,  in  case  of  minors  and  of 
incapacitated  subjects,  an  authorisation  or  agreement  from  their  legally 
designated  representative  to  include  them  in  a  clinical  trial,  including 
consent  given  through  the  use  of  electronic  systems,  methods  and 
processes,  and  signed  electronically  in  accordance  with  Union  law  or 
equivalent standards;’ 

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(f) 

the following points (36), to 47 are inserted: 

(36)  ‘Consideration’ means a justified concern or divergent view raised by a 
Member  State  concerned  in  the  process  of  an  assessment  of  an 
application  for  an  authorisation  of  a  clinical  trial  or  for  a  substantial 
modification  on the aspects that, if unresolved, will result in a negative 
decision on the clinical trial or substantial modification application; 

(37)  ‘Reporting Member State’ means the Member State concerned that:  

(a) 

(b) 

is  responsible  for  the  assessment  and  authorisation  of  the  clinical 
trial application in mono-national clinical trials, or 

is  leading  the  assessment  for  the  authorisation  of  a  multinational 
clinical  trial  or  of  a  substantial  modification  regarding  aspects 
covered by Part I of the application dossier, or  

(c) 

is  leading  the  assessment  for  the  authorisation  of  a  multinational 
combined study; 

(38)  ‘Investigational  medicinal  product  core  dossier’  means  a  dossier, 
containing  documents  referred  to  in  point  (Ga),  Part  II  of  Annex  I 
concerning  the  investigational  medicinal  product,  established  at  the 
request  of  the  sponsor  in  view  of    supporting  the  development  of  the 
investigational medicinal product. 

(39)  ‘Core  dossier  depositary  Member  State’  means  a  Member  State 
the 
responsible 
investigational  medicinal  product  core  dossier  to  be  established  and  for 
the regulatory oversight of an already established dossier; 

suitability  and  completeness  of 

for  assessing 

(40)  ‘Core  dossier  competent  Member  States’  means  the  Member  States 
concerned  for  all  corresponding  clinical  trials  and  the  Member  States 
indicated  by  a  sponsor  at  the  time  of  the  initial  request  for  the 
establishment of the investigational medicinal product core dossier; 

(41)  ‘Corresponding  clinical  trial’  means  a  clinical  trial  tested  to  the 
investigational  medicinal  product  for  which  an  establishment  of  an 
investigational  medicinal  product  core  dossier  has  been  requested  and 
any  subsequent  clinical  trial  tested  to  that  investigational  medicinal 
product; 

(42)  ‘Distribution’  means  all  activities,  consisting  of  procuring,  holding, 
supplying,  shipping  across  Member  States  or  exporting  investigational 
medicinal product or auxiliary medicinal products, , including delivery of 
investigational  and  auxiliary  medicinal  products  to  the  clinical  trial 
participants; 

(43)  ‘Direct delivery to the subject’ means controlled and documented direct 
delivery of an investigational medicinal product or an auxiliary medicinal 
product to the subject’s place of residence in a Member State, where the 
clinical trial has been authorised; 

(44)  ‘Combined  study’  means  a  clinical  trial  concerning  one  or  more 
medicinal products combined with a performance study of one or more in 
vitro  diagnostic  medical  devices,  as  defined  in  Article  2  point  (42)  of 
Regulation  (EU)  2017/746  of  the  European  Parliament  and  of  the 

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Council *and/or clinical investigation of one or more medical devices as 
defined  in  Article  2  point  (45)  of  Regulation  (EU)  2017/745  of  the 
European Parliament and of the Council **; 

(45)  'Regulatory  sandbox'  means  a  regulatory  framework  that  allows  for  the 
development and testing of innovative or adapted regulatory  approaches 
in a controlled environment pursuant to a specific plan, for a limited time 
and  under  regulatory  supervision,  that  enables  innovation  driven 
approaches  to  an  authorisation    and    conduct  of  clinical  trials  that  
otherwise  would    not  be  possible  or  appropriate  given  current  legal 
framework;’ 

(46)  ‘AI  system’  means  AI  system  as  defined  in  Article  3(1)  of  Regulation 
(EU) 2024/1689 of the European Parliament and of the Council***; 

(47)  ‘serious  cross-border  threat  to  health’  means  serious  cross-border  threat 
to health as defined in Article 3(1) of Regulation (EU) 2022/2371 of the 
European Parliament and of the Council****‘ 

*  

Regulation  (EU)  2017/746  of  the  European  Parliament  and  of  the 
Council  of  5  April  2017  on  in  vitro  diagnostic  medical  devices  and 
repealing  Directive  98/79/EC  and  Commission  Decision  2010/227/EU 
(JO 5.5.2017, L117/176.,  ELI: http://data.europa.eu/eli/reg/2017/746/oj). 

**  Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the 
Council  of  5  April  2017  on  medical  devices,  amending  Directive 
2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 
(JO 5.5.2017, L 117/1., ELI: http://data.europa.eu/eli/reg/2017/745/oj). 

***   Regulation  (EU)  2024/1689  of  the  European  Parliament  and  of  the 
Council  of  13  June  2024  laying  down  harmonised  rules  on  artificial 
intelligence  and  amending  Regulations  (EC)  No  300/2008,  (EU)  No 
167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 
2019/2144  and  Directives  2014/90/EU,  (EU)  2016/797  and  (EU) 
12.7.2024, 
2020/1828 
ELI: http://data.europa.eu/eli/reg/2024/1689/oj) 

2024/1689, 

(OJ 

L, 

****  Regulation  (EU)  2022/2371  of  the  European  Parliament  and  of  the 
Council  of  23  November  2022  on  serious  cross-border  threats  to  health 
and  repealing  Decision  No  1082/2013/EU  (OJ  L  314,  6.12.2022,  p.  26, 
http://data.europa.eu/eli/reg/2022/2371/oj). 

(2) 

Article 3 is replaced by the following:  

‘Article 3 

General principles 

1.  A clinical trial may be conducted only if: 

(a) 

the  rights,  safety,  dignity  and  well-being  of  subjects  are  protected  and 
prevail over all other interests; and 

(b) 

it is designed to generate reliable and robust data. 

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2.  Member States concerned shall cooperate closely and efficiently to ensure the 

effective and timely application of the provisions of this Regulation. 

3.  Member  States  shall  take  into  account  whether  a  clinical  trial  is  a  minimal-
intervention or low-intervention  clinical trial and, where this is the case, adapt 
the  regulatory  requirements  throughout  the  lifecycle  of  such  clinical  trial,  in 
particular with  regard to the application dossier, the authorisation  procedures, 
the safety reporting and oversight.’ 

(3) 

Articles 4 and 5 are replaced by the following: 

’Article 4 

Prior authorisation 

A clinical trial shall be conducted only if it has been authorised by the Member State 
concerned in accordance with this Regulation. Applications for an authorisation shall 
be subject to scientific and ethical review. 

In  clinical  trials  concerning  more  than  one  Member  States  (multinational  clinical 
trials) all the Member States concerned including the reporting Member  State shall 
cooperate  in  good  faith  and  in  spirit  of  mutual  trust  and  reliance.  The  reporting 
Member State shall have a leading role in the assessments.  

The ethical review shall be performed by an ethics committee in accordance with the 
law  of  the  Member  State  concerned.  The  reporting  Member  State  shall  involve  its 
ethics  committee  in  the  assessment  of  ethical  aspects  of  Part  I  of  the  application 
dossier referred to in Article 6.  

Each Member State shall ensure that the organisation,  timelines and procedures for 
the review by an ethics committee are compatible with the timelines and procedures 
set out in this Regulation for the assessment of the application for authorisation of a 
clinical trial and substantial modifications thereof. 

Article 5 

Submission of an application 

1. 

In  order  to  obtain  an  authorisation,  the  sponsor  shall  submit  an  application 
dossier to the intended Member States concerned throughout the Portal referred 
to in Article 80 (‘the EU portal’) referred to in Article 25. The date on which 
the  sponsor  submits  the  application  for  an  authorisation  of  a  clinical  trial  is 
referred to within this Chapter as the submission date. 

2. 

The authorisation procedure of a clinical trial consists of three steps: 

(a) 

a validation of the application dossier, as set out in Article 5b; 

(b) 

an assessment, that consists of: 

– 

an assessment of Part I, as  set out in Article 6, of the elements of 
the  application  dossier  listed  in  Part  I  of  Annex  I,  that  constitute 
Part I of the assessment dossier, and 

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– 

an  assessment  of  Part  II,  as  set  out  Article  7  of  the  application 
dossier, of the elements listed in Part II of Annex I, that constitute 
Part II of the application dossier. 

(c) 

a  decision  resulting  either  an  authorisation,  conditional  authorisation  or 
refusal of an authorisation, as set out in Article 8.’ 

(4) 

the following Articles 5a and Article 5b are inserted: 

“Article 5a 

Appointment of the reporting Member State 

1. 

2. 

3. 

4. 

In clinical trials  concerning only one Member State, this Member State is the 
reporting Member State.  

In  clinical  trials  concerning  more  than  one  Member  States,  the  sponsor  shall 
propose  one  of  the  Member  States  concerned  as  the  reporting  Member  State. 
All  Member  States  concerned  willing  to  become  the  reporting  Member  State 
shall declare their willingness through the EU portal.  

The sponsor shall, when applying for a low-intervention clinical trial propose 
one  of  the  Member  States  concerned  where  the  use  of  the  investigational 
medicinal product is evidence-based as a reporting Member State. 

If the proposed Member State accepts  the proposal  by expressing willingness 
to become the reporting Member State, it shall be the reporting Member State. 

If the proposed Member State does not accept the proposal, the following rules 
shall apply, and their application shall be supported by the EU Portal: 

(a)  where there is only one other Member State concerned willing to become 
the  reporting  Member  State,  that  Member  State  shall  become  the 
reporting Member State; 

(b)  where there is more than one Member State concerned willing to become 
the reporting Member State or none of the Member States  concerned is 
willing  to  become  the  reporting  Member  State,  the  reporting  Member 
State shall be designated automatically by the EU Portal in application of 
the recommendation referred to in article 85(2)(c). 

5.  Within three  days from the submission date, all Member States concerned, the 
sponsor and the reporting Member State shall be notified by the EU  Portal of 
the appointment of the reporting Member State. 

Article 5b 

Validation of Part I of the application dossier 

1.  Within seven days from the submission date, the reporting Member State shall 
validate  Part  I  of  application  dossier  referred  to  in  Article  6  and  notify  the 
sponsor, through the EU portal, of the following: 

(a)  whether  the  clinical  trial  applied  for  falls  within  the  scope  of  this 

Regulation;  

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(b)  whether the application dossier is complete in accordance with  Part I of 

Annex I; 

(c)  whether  it  confirms  that  the  clinical  trial  is  a  minimal-intervention  or  a 
low- intervention clinical trial, respectively, if such a claim was made by 
the sponsor. 

2.  Where  the  reporting  Member  State  has  not  notified  the  sponsor  within  the 
period referred to in paragraph 1, the clinical trial applied for shall be deemed 
to fall within the scope of this Regulation and the application dossier shall be 
considered  complete and, if applicable, the  clinical  trial  shall be considered  a 
minimal-intervention or low-intervention clinical trial. 

3.  Where  the  reporting  Member  State  finds  that  the  application  dossier  is  not 
complete, or that the clinical trial applied for does not fall within the scope of 
this  Regulation,  or,  if  applicable,  has  doubts  whether  the  clinical  trial  is  a 
minimal-intervention  or  low-intervention  clinical  trial,  the  reporting  Member 
State shall: 

(a) 

inform the sponsor thereof through the EU portal and shall set a deadline 
of maximum seven days for the sponsor to comment on the application or 
to complete the application dossier through the EU portal; 

(b)  within seven days from the submission of the comments or the completed 
application  dossier  referred  to  in  point  (a)  notify  the  sponsor  as  to 
whether or not the application complies with the requirements set out in 
paragraph 1 points (a), (b) and (c). 

In  case  the  reporting  Member  State  requests  the  sponsor  to  comment  on  the 
application  pursuant  to  this  paragraph,  the  period  referred  to  in  paragraph  1 
may be extended by a maximum of 14 days. 

4.  Where  the  reporting  Member  State  has  not  notified  the  sponsor  within  the 
period referred to in paragraph 3, point (b), the clinical trial applied for shall be 
deemed to fall within the scope of this Regulation, the application dossier shall 
be considered  complete  in  accordance with  Part  I of Annex  I and the clinical 
trials  is  deemed  to  be  a  minimal-intervention  or  a  low-intervention  clinical 
trial, if claimed by the sponsor. 

5.  Where  the  sponsor  has  not  provided  comments  or  completed  the  application 
dossier within the period referred to  in  paragraph 3, point (a), the application 
shall be deemed to have lapsed in all Member States concerned. 

6. 

For  the  purpose  of  this  Chapter,  the  date  on  which  the  sponsor  is  notified  in 
accordance  with  paragraph  1  or  paragraph  3,  point  (b)  shall  be  the  validation 
date  of  the  application.  Where  the  sponsor  is  not  notified  within  these  time 
periods, the validation date shall be the last day of respective periods referred 
to in paragraph 1 or paragraph 3, point (b).” 

(5) 

Article 6 is replaced by the following: 

Assessment report – Aspects covered by Part I of the assessment report 

’Article 6 

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1. 

The  reporting  Member  State  shall  assess  the  application  relying  on  the 
information  and the documents listed in  Part I of Annex  I, with  regard to  the 
following aspects: 

(a) 

compliance with Chapter V as with respect to the following: 

(i) 

the  anticipated  therapeutic  and  public  health  benefits  taking 
account of all of the following: 

– 

– 

characteristic  of  and  knowledge  about  the  investigational 
medicinal products; 

relevance of the clinical trial, including whether the groups of 
subjects  participating  in  the  clinical  trial  represent  the 
population  to  be  treated,  or  if  not,  the  explanation  and 
justification provided in accordance with point 17(y) of Part I 
of Annex I; the current state of scientific knowledge; whether 
the  clinical  trial  has  been  recommended  or  imposed  by 
regulatory  authorities  in  charge  of  the  assessment  and 
authorisation  of  the  placing  on  the  market  of  medicinal 
products;  where  applicable,  taking  into  account  any  opinion 
formulated  by  the  Paediatric  Committee  on  paediatric 
investigational  plan  in  accordance  with  Chapter  VII  of 
Regulation  (EU) …/…[reference to  be added after adoption 
cf. COM(2023)196final]; 

– 

reliability  and  robustness  of  the  data  generated  in  clinical 
trial,  taking  into  account  of  statistical  approaches,  design  of 
the clinical trial and methodology, including sample size and 
randomisation, comparator and endpoints; 

(ii) 

risk and inconveniencies for the subjects, taking into account all of 
the following: 

– 

– 

– 

– 

– 

characteristic  of  and  knowledge  about  the  investigational 
medicinal product and the auxiliary medicinal product; 

characteristic of the investigational medicinal product; 

safety  measures,  including  provisions  for  risk  minimisation 
measures, monitoring, safety reporting, and the safety plan; 

risk  to  subjects’  health  posed  by  the  medical  condition  for 
is  being 
investigational  medicinal  product 
which 
investigated; 

the 

aspects related to the protection of the subjects’ safety, well-
being and fundamental rights as a clinical trial participant. 

(b) 

compliance  with  the  requirements  concerning  the  manufacturing  and 
import of investigational medicinal product set out in Chapter IX; 

(c) 

compliance with the labelling requirements set out in Chapter X; 

(d) 

completeness and adequacy of the investigator’s brochure.  

The  adequacy  of  the  translations  of  the  documents,  when  translations  are 
required  pursuant  to  Article  26  and  Article  69,  submitted  in  Part  I  shall  be 
assessed in Part II. 

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2. 

The  reporting  Member  State  shall  draw  up  an  assessment  report.  The 
assessment of the aspects referred to in paragraph 1 shall constitute Part I of the 
assessment report.  

The  ethics  committee  of  the  reporting  Member  State  shall  review,  from  the 
ethical  perspective,  aspects  covered  by  Part  I  of  the  assessment  report.  That 
ethical  review  shall  complement  the  scientific  and  regulatory  assessment  and 
shall  cover  Part  I  of  the  application  dossier  in  order  to  evaluate  whether  the 
subjects’ rights, safety and well-being are being ensured in the clinical trial.” 

2a.  Notwithstanding paragraph 2, where the clinical trial is a minimal-intervention 
clinical trial, the assessment of the reporting Member State shall be limited to 
an  ethical  review  by  its  ethics  committee  of  the aspects  referred  to  points  (a) 
and (d) of paragraph 1. 

3. 

The  assessment  report  shall  contain  one  of  the  following  conclusions 
concerning the aspects addressed in Part I of the assessment report: 

(a) 

(b) 

the conduct of the clinical trial is acceptable in view of the requirements 
set out in this Regulation: 

the conduct of the clinical trial is acceptable in view of the requirements 
set  out  in  this  Regulation,  but  subject  to  compliance  with  specific 
conditions which shall be specifically listed in that conclusion; or 

(c) 

the  conduct  of  the  clinical  trial  is  not  acceptable  in  view  of  the 
requirements set out in this Regulation. 

The reporting Member state shall submit, through EU portal, the final Part I of 
the  assessment  report,  including  its  conclusions,  to  the  sponsors  and  to  the 
other Member States concerned within 42 days from the submission date. 

For  clinical  trials  involving  more  than  one  Member  State  concerned,  the 
assessment process shall include three phases: 

4. 

5. 

(a) 

an initial assessment phase within 28 days from the submission date; 

(b) 

a review phase within seven days from the end of the initial assessment; 

(c) 

a consolidation phase within seven days from the end date of the review 
phase.  

During  the  initial  assessment  phase,  the  reporting  Member  State  shall  assess 
Part  I  of  the  application  dossier  and  draw  up  a  draft  Part  I  of  the  assessment 
report  and  circulate  it  to  all  other  Member  States  concerned  within  28  days 
from the submission date. 

During  the  review  phase,  within  seven  days  from  the  circulation  of  the  draft 
assessment  report  all  Member  States  concerned  shall  review  the  application 
based on the draft Part I of the assessment report and shall share considerations 
for their Member States relevant to the application. The consideration may be 
raised only on one of the following grounds: 

(a) 

(b) 

one of the grounds referred to in Article 8(2);  

issues  that  would  lead  to  a  negative  opinion  of  the  ethics  committee  of 
the Member State concerned. 

During  the  consolidation  phase,  the  reporting  Member  State  shall  take  due 
account  of  the  considerations  of  the  other  Member  States  concerned  and 

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finalise Part I of the assessment report and shall record how all considerations 
have been dealt with. The reporting Member State shall submit the final Part I 
of the assessment report to the sponsor and all other Member States concerned 
within seven days from the end of the review phase.” 

5a.  Where  the  clinical  trial  is  a  minimal-intervention  clinical  trial,  other  Member 
States  concerned  may  only  raise  during  the  review  phase  considerations 
referred  to  in  paragraph  5related  to  ethical  aspects  of  the  draft  assessment 
report.” 

6. 

7. 

For  the  purpose  of  this  Chapter,  the  date  on  which  the  final  Part  I  of  the 
assessment  report  is  submitted  by  the  reporting  Member  State  to  the  sponsor 
and to the other Member States concerned through the EU portal shall be the 
reporting date.” 

Between the validation date and the reporting date, only the reporting Member 
State may request additional information from the sponsor, taking into account 
the considerations referred to in paragraph 5. 

For  the  purpose  of  obtaining  and  reviewing  this  additional  information  from 
the sponsor, the reporting Member State may extend the period referred to in 
paragraph 4 by maximum of 28 days. 

The sponsor shall submit the requested information within the period set by the 
reporting Member State which shall not exceed 14 days from the receipt of the 
request. 

Upon  receipt  of  the  requested  additional  information,  the  Member  State 
concerned  shall  review  additional  information  provided  by  the  sponsor  and 
shall  identify  and  share  with  the  reporting  Member  State  any  unaddressed 
considerations,  relevant  for  the  application.  The  coordinated  review  shall  be 
performed within maximum 7 days of the receipt of the additional information 
and the further consolidation shall be performed within maximum seven days 
of the end of the coordinated review. When finalising Part I of the assessment 
report, the reporting Member State shall take due account of the considerations 
of the other Member States concerned and shall record how the considerations 
have been dealt with. 

Where  the  sponsor  does  not  provide  additional  information  within  the  period 
set by the reporting Member State in accordance with the third subparagraph, 
the application shall be deemed to have lapsed in all Member States concerned. 

The  request  for  additional  information  and  additional  information  shall  be 
submitted through the EU Portal.’ 

(6) 

Article 7 is replaced by the following: 

‘Article 7 

Assessment report – Aspects covered by Part II of the application dossier  

1. 

Each Member State concerned shall assess, for its own territory, the application 
with respect to the following aspects. Such assessment shall constitute Part II 
of the assessment report:  

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(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

compliance  with  the  requirements  for  informed  consent  set  out  in 
Chapter V; 

compliance of the arrangements for rewarding or compensating subjects 
with the requirements set out in Chapter V; 

compliance  of  the  arrangements  for  recruitment  of  subjects  with  the 
requirements set out in Chapter V; 

compliance with  Regulation  (EU) 2016/679 of the European Parliament 
and of the Council*; 

compliance with Article 49; 

compliance with Article 50; 

compliance with Article 76; 

compliance  with  applicable  rules  for  the  collection,  storage  and  future 
use of biological samples of the subject; 

accuracy of the translations of the documents and information submitted 
in Part I of the application dossier, when such documents are required to 
be submitted in the national language in accordance with Article 26 and 
69. 

2. 

Each  Member  State  concerned  shall  complete  the  assessment  within  42  days 
from  the  submission  date  and  submit,  through  the  EU  portal,  Part  II  of  the 
assessment report, including its conclusions, to the sponsor. 

Each  Member  State  concerned  may  within  the  period  referred  to  in  this 
paragraph, and through EU portal, request on duly justified grounds additional 
information , from the sponsor regarding the aspects covered in paragraph 1 or 
to  request  to  complement  the  documentation,  required  pursuant  to  Part  II  of 
Annex  I,  if  such  documentation  is  missing  or  documentation  provided  is  not 
adequate or is incomplete.  

The  Member  State  concerned  may  decide  within  28  days  of  the  submission 
date  to  rely  on  the  ethical  review  of  the  ethics  committee  of  the  reporting 
Member State of the common elements of the application dossier of Part II and 
inform the sponsor accordingly. 

3. 

Each Member State concerned may extend the assessment period referred to in 
paragraph 2 by a maximum of 28 days: 

(a) 

(b) 

to  requests  additional  documentation  or  information,  as  referred  in 
paragraph 2, from the sponsor regarding Part II of the assessment for its 
territory; 

to  align  with  the  timeline  for  the  assessment  referred  to  in  Article  6, 
when it has been extended to allow for a request for information by the 
reporting Member State related to Part I assessment and its review. 

information  and 
The  sponsor  shall  submit 
documentation  within  the  period  set  by  the  Member  State  concerned  which 
shall not exceed 14 days from the receipt of the request. 

requested  additional 

the 

Upon  receipt  of  the  additional  information  and  documentation,  the  Member 
State  concerned  shall  complete  its  assessment  within  maximum  of  14  days 
from the submission of the requested information by the sponsor. 

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Where the sponsor does not provide additional information and documentation 
within the period set  by  the Member State concerned in  accordance with this 
paragraph, the application shall be deemed to have lapsed in that Member State 
concerned. 

* Regulation (EU) 2016/679 of the European Parliament and of the Council of 
27  April  2016  on  the  protection  of  natural  persons  with  regard  to  the 
processing  of  personal  data  and  on  the  free  movement  of  such  data,  and 
repealing Directive 95/46/EC (General Data Protection Regulation), OJ  L 119, 
4.5.2016., ELI: http://data.europa.eu/eli/reg/2016/679/oj.’ 

(7) 

in Article 8, paragraphs 1 and 2 are replaced by the following: 

‘1.  Each Member State concerned shall notify the sponsor through the EU portal 
and by way of one single decision as to whether the clinical trial is authorised, 
authorised subject to conditions, or whether authorisation is refused. 

The notification shall be made within five days from the reporting date or from 
the last day of the assessment referred to in Article 7, whichever is later. 

2.  Where  the  conclusion  of  the  reporting  Member  State  as  regards  Part  I  of  the 
assessment  report  is  that  the  conduct  of  the  clinical  trial  is  acceptable  or 
acceptable subject to compliance with specific conditions, that conclusion shall 
be deemed to be the conclusion of the Member States concerned.  

A  clinical  trial  subject  to  conditions  may  start,  unless  the  Member  State 
concerned  specified  that  the  condition  is  suspensive.  Unless  otherwise 
specified,  a  fulfilment  of  the  condition  shall  not  require  a  submission  of  a 
request for a substantial modification. 

Notwithstanding  the  first  subparagraph  of  this  paragraph,  a  Member  State 
concerned may disagree with the conclusion of the reporting Member State as 
regards Part I of the assessment report only on the following grounds, provided 
that the corresponding consideration was raised during the process pursuant to 
Article 6(5) point (b) and the Member State concerned considers that it was not 
sufficiently addressed: 

(a) 

participation  in  the  clinical  trial  would  lead  to  a  subject  receiving  an 
inferior  treatment  than  in  normal  clinical  practice  in  the  Member  State 
concerned; or 

(b) 

infringement of its national law as referred to in Article 90. 

Where  a  Member  State  concerned  disagrees  with  the  conclusion,  it  shall 
communicate  its  disagreement,  together  with  a  detailed  justification,  through 
the EU portal, to the Commission, to all Member States, and to the sponsor.’ 

(8) 

Article 9 is replaced by the following: 

‘Article 9 

Persons assessing the application 

1.  Member States shall ensure, including through the institutional safeguards, that 
persons  validating  and  assessing  the  application  do  not  have  conflicts  of 
interest,  are  independent  of  the  sponsors,  or  the  clinical  trial  site  and  the 

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investigators involved and of persons financing the clinical trial, as well as free 
of  any  other  undue  influence  and  ensure  their  sufficient  independence  in 
performance of their tasks.  

In order to guarantee independency and transparency, the Member States shall 
ensure  that  persons  validating    and  assessing  the  application  as  regards  the 
aspects covered in Parts I and II of the assessment report have no financial or 
personal  interests  which  could  affect  their  impartiality.  These  persons  shall 
make an annual declaration of their financial interest. 

2.  Member  States  shall  ensure  that  the  assessment  is  done  by  persons  who 

collectively have the necessary qualifications and experience. 

These persons shall be sufficiently equipped and empowered to  perform their 
tasks. 

3.  At least one layperson shall participate in the assessment.’  

(9) 

in Article 10, the following paragraph 6 is added: 

’6.  Where  potential  subjects  of  a  clinical  trial  belong  to  vulnerable  populations, 
Member States concerned and sponsors shall consider and weigh the harms and 
benefits  of  their  inclusion  as  opposed  to  their  exclusion  from  a  clinical  trial. 
The Member States concerned and sponsors shall assess in particular whether 
the  exclusion  of  those  subjects  from  a  clinical  trial  could  inadvertently 
perpetuate  or  exacerbate  their  vulnerabilities,  particularly  in  relation  to  their 
specific health needs.’ 

(10) 

Article 11 is replaced by the following: 

 ‘ Article 11 

Submission and assessment of applications limited to aspects covered by Part I of the 
assessment report 

1.  Where  the  sponsor  so  requests,  the  application  for  authorisation  of  a  clinical 
trial, its assessment and the conclusion shall be limited to the aspects covered 
by Part I of the assessment report. 

After the notification of the conclusion on the aspects covered by Part I of the 
assessment  report,  the  sponsor  may,  within  two  years,  apply  for  an 
authorisation limited to aspects covered by Part II of the assessment report. 

Where the sponsor submits  only  Part I of the  application dossier to  all of the 
Member  States  concerned,  the  sponsor  shall  declare  at  the  time  of  the  first 
submission  of  Part  II  of  the  application  dossier  to  any  of  the  Member  States 
concerned  that  the  sponsor  is  not  aware  of  any  new  substantial  scientific 
information  that  would  change  the  validity  of  any  item  submitted  in  the 
application  on  the  aspects  covered  by  Part  I  of  the  assessment  report.  If  an 
update of Part I of the application dossier is necessary, the sponsor shall submit 
a  substantial  modification  of  Part  I  of  the  application  dossier,  at  the  latest,  at 
the same time as the submission of Part II of the application dossier to at least 
one of the Member States concerned.  

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The  Part  II  of  the  application  dossier  shall  be  assessed  in  accordance  with 
Article 7 and the Member State concerned shall notify the decision on clinical 
trial in accordance with Article 8. 

In  those  Member  States  concerned  where  the  sponsor  does  not  apply  for  an 
authorisation  limited  to  aspects  covered  by  Part  II  of  the  assessment  report 
within  two  years,  the  application  on  the  aspects  covered  by  Part  I  of  the 
assessment report shall be deemed to have lapsed. 

2.  When  the  sponsor  submits  a  substantial  modification  of  Part  I  of  the 
application  dossier  with  regard  to  clinical  trial  that  is  subject  to  a  request 
referred  to  in  paragraph  1  and  has  been  authorised  or  authorised  subject  to 
conditions  by  at  least  one  Member  State  concerned,  all  Member  States 
concerned  that  received  the  initial  application  shall  participate  in  the 
assessment of that substantial modification in accordance with Article 18 or 22 
as appropriate.’ 

(11) 

Article 14 is amended as follows: 

(a) 

paragraph 1 is replaced by the following:  

‘1.  Where the sponsor wishes to extend an authorised clinical trial to another 
Member  State  (additional  Member  State  concerned),  the  sponsor  shall 
submit  an  application  dossier  to  that  Member  State  through  the  EU 
portal.  

The application dossier may be submitted only after the notification date 
of  the  first  initial  authorisation  decision  by  at  least  one  Member  State 
concerned.’ 

(b)  paragraph 3 is replaced by the following: 

‘3.  The additional Member State concerned shall notify the sponsor, through 
the  EU  portal,  within  47  days  from  the  date  of  submission  of  the 
application dossier  referred to  in  paragraph  1  of this  Article,  by  way of 
one single decision as to whether the clinical trial is authorised, whether 
it  is  authorised  subject  to  conditions,  or  whether  the  authorisation  is 
refused.  Article  8(2),  (3),  (4)  and  (5)  apply  to  the  decision  of  the 
additional Member State concerned.’ 

(c) 

paragraph 4 is deleted; 

(d)  paragraph 5 to 8 are replaced by the following: 

‘5.  Within 42 days following the submission date referred to in paragraph 1, 
the  additional  Member  State  concerned  may  communicate  to  the 
reporting  Member  State  and  the  other  Member  States  concerned  any 
considerations through the EU portal.’ 

(e) 

paragraphs 6, 7 and 8 are replaced by the following: 

‘6.  Between the submission date referred to in paragraph 1 and the expiry of 
the  period  referred  to  in  paragraph  3,  only  the  reporting  Member  State 
may  request  additional  information  from  the  sponsor  concerning  the 
aspects covered in Part I of the assessment report, taking into account the 
considerations referred to in paragraph 5.  

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For  the  purpose  of  obtaining  and  reviewing  this  additional  information 
from the sponsor in accordance with the third and fourth subparagraphs, 
the reporting Member State may extend the period referred to in the first 
subparagraph of paragraph 3 by a maximum of 28 days. 

The sponsor shall submit the requested additional information within the 
period set by the reporting Member State, which shall not exceed 14 days 
from receipt of the request. 

Upon  receipt  of  the  additional  information  the  reporting  Member  State, 
the  additional  Member  State  concerned  and  all  other  Member  States 
concerned  shall  review  any  additional  information  provided  by  the 
sponsor  together  with  the  original  application  and  shall  share  any 
unaddressed  considerations  relevant  to  the  application.  The  coordinated 
review  shall  be  performed  within  a  maximum  of  seven  days  from  the 
receipt  of  the  additional  information  and  the  further  consolidation  shall 
be  performed  within  a  maximum  of  seven  days  from  the  end  of  the 
coordinated review. The reporting Member State shall take due account 
of  the  considerations  of  the  Member  States  concerned  and  shall  record 
how the considerations have been dealt with.  

Where  the  sponsor  does  not  provide  additional  information  within  the 
period  set  by  the  reporting  Member  State  in  accordance  with  the  third 
subparagraph,  the  application  shall  be  deemed  to  have  lapsed  in  the 
additional Member State concerned. 

The  request  for  additional  information  and  the  additional  information 
shall be submitted through the EU portal 

The additional Member State concerned shall assess, for its territory, the 
aspects  covered  in  Part  II  of  the  assessment  report  and  submit  Part  II 
assessment report, including its conclusions, through the EU portal, to the 
sponsor.  

Within  period  referred  to  in  paragraph  3,  additional  Member  State  may 
request,  through  the  EU  portal,  with  justified  reasons,  additional 
information from the sponsor regarding aspects covered in Part II of the 
assessment report as far as its territory is concerned.’ 

For  the  purpose  of  obtaining  and  reviewing  the  additional  information 
referred  to  in  paragraph  6  or  7  the  additional  Member  State  concerned 
may  extend  the  period  referred  to  in  paragraph  5  by  maximum  of  28 
days.  

The sponsor shall submit the requested additional information within the 
period  set  be  the  additional  Member  State  concerned,  which  shall  not 
exceed 14 days from the receipt of the request.  

Upon receipt of the additional information, the Member State concerned 
shall compete its assessment within a maximum of 14 days. 

Where  the  sponsor  does  not  provide  additional  information  within  the 
period set by the additional Member State concerned in accordance with 
second subparagraph, the application shall be deemed to  have lapsed in 
the additional Member State concerned.’ 

7. 

8. 

(f) 

paragraphs 9 and 10 are deleted; 

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(g)  paragraphs 11 and 12 are replaced by the following: 

‘11.  Where  the  additional  Member  State  concerned  has  not  notified  the 
sponsor of its decision within the period referred to in paragraph 3, or in 
case that period has been extended in accordance with paragraph  6 or 8 
and  where  that  additional  Member  State  concerned  has  not  notified  the 
sponsor of its decision within the extended period, the conclusion on Part 
I  of  the  assessment  report  shall  be  deemed  to  be  the  decision  of  that 
additional  Member  State  concerned  on  the  application  for  authorisation 
of the clinical trial.” 

12.  A sponsor shall not submit an application dossier in accordance with this 
Article where a procedure for a substantial modification of Part I of the 
assessment  report,  set  out  in  Chapter  III,  is  pending  as  regards  that 
clinical trial.’ 

(12) 

the following Article 14a is inserted: 

’Article 14a 

Appointment of a new reporting Member State 

1. 

The reporting Member State may initiate the procedure for an appointment of a 
new reporting Member State if: 

2. 

3. 

4. 

5. 

6. 

(a) 

the  reporting  Member  State  has  notified  its  decision  refusing  the 
authorisation of the clinical trial; or 

(b) 

the clinical trial is no longer taking place in the reporting Member State. 

The procedure can only be launched after the clinical trial has been authorised 
in at least one Member State concerned. 

The reporting Member State shall notify the sponsor and other Member States 
concerned of its intention to cease to be a reporting Member State. 

The  Member  States  concerned  shall  declare  their  willingness  to  become  new 
reporting  Member  State.  The  selection  of  new  reporting  Member  State  shall 
follow the rules established Article 5a (4) and (5).  

Following  the  initiation  of  the  procedure  for  the  appointment  of  a  new 
reporting  Member  State,  the  initial  reporting  Member  State  shall  continue  to 
carry  out  its  tasks  until  all  of  the  ongoing  assessments  and  records  are 
completed and the respective final assessment reports are submitted to the EU 
portal.  

The new reporting Member State shall become responsible for the assessment 
of  any  application  related  to  Part  I  of  the  assessment  report,  including  an 
application  based  on  Article  14,  that  has  been  submitted  after  it  has  been 
notified  as  the  reporting  Member  State  to  the  sponsor  and  all  Member  States 
concerned by the EU portal.’ 

(13) 

the following Chapter IIa is inserted: 

‘Chapter IIa 

SPECIAL AUTHORISATION PROCEDURES 

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Article 14b 

Accelerated procedure for the authorisation of multinational clinical trials in the context of  
public health emergencies 

1.  During a recognised public health emergency at Union level pursuant to Article 
23  of  Regulation  (EU)  2022/2371  of  the  European  Parliament  and  of  the 
Council,  Member  States  shall  apply  an  accelerated  procedure  for  the 
authorisation of multinational clinical trials for medicinal products intended for 
the  treatment,  prevention  or  medical  diagnosis  of  the  disease  or  condition 
which are directly related to the public health emergency.  

2. 

3. 

To  address  an  emergence  or  development  of  a  serious  cross-border  threat  to 
health as defined in Article 3(1) of Regulation 2022/2371 that is likely to lead 
to  the  recognition  of  a  public  health  emergency  at  Union  level  in  accordance 
with  Article 23(1) of Regulation  (EU) 2022/2371, Member States  shall  apply 
an  accelerated  procedure  for  the  authorisation  of  multinational  clinical  trials 
when this procedure is  declared applicable in accordance with  the criteria   in 
paragraph 3 of this Article. The application of the accelerated procedure shall 
ensure  the  availability  of    medicinal  products  in  order  to prevent  or  swiftly 
contain  the  emerging  serious  cross-border  health  threat,  to  provide   timely 
treatment  options  grounded  in  scientifically  robust  evidence  or  to  facilitate 
medical  diagnosis  of  the  disease  or  condition  directly  related  to  the  specific 
serious cross-border health threat.  

The Commission shall, by means of implementing acts, lay down the detailed 
criteria  and  the  processes  for  declaring  applicability  of  the  accelerated 
authorisation  procedure  to  address  an  emergence  or  development  of    serious 
cross-border threat to health that is likely to lead to the recognition of a public 
health  emergency  at  Union  level  in  accordance  with  Article  23  (1)  of 
Regulation (EU) 2022/2371, .  

The  criteria  for  declaring  applicability  of  an  accelerated  authorisation 
procedure shall at least include the epidemiological situation and its dynamics 
as  well  as  the  availability  of  treatment,  prevention  and  diagnostics  options 
addressing  the  emerging  serious  cross-border  threat  to  health.  The  process  of 
declaring applicability of the accelerated authorisation procedure shall involve 
consultations with relevant Union agencies, expert groups and advisory bodies 
in the field of public health and clinical trials. 

The implementing acts referred to in the first subparagraph shall be adopted in 
accordance with the examination procedure referred to in Article 88. 

4.  When  submitting  the  application  for  the  clinical  trial  authorisation  during  a 
public health emergency as referred to in paragraph 1 or when the accelerated 
procedure  referred  to  in  paragraph  2  is  declared  applicable  to  address  an 
emerging serious cross-border health threat, pursuant to the procedure referred 
to  in  paragraph  3,  the  sponsor  shall  indicate  whether  the  investigational 
medicinal  products  are  intended   for  the  treatment,  prevention  or  medical 
diagnosis  of  a  disease  or  a  condition  directly  related  to  the  specific  serious 
cross-border  threat  to  health.  The  reporting  Member  State  shall  confirm 
whether the accelerated procedure is applicable to the clinical trial application. 

5. 

The Commission  shall adopt  delegated acts   in  accordance with  Article 89  to 
supplement  this  Regulation  by  setting  out  the  procedures  for  an  accelerated 

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authorisation  of  multinational  clinical  trials,  including  timelines,  criteria  for 
evaluating whether a clinical trial qualifies for an accelerated procedure and an 
integrated ethical review, and by laying down  simplified requirements for the 
application dossier.  

Article 14c 

Combined studies 

1. 

2. 

3. 

4. 

5. 

This  Article  applies to  combined studies in  which a clinical  trial  is  combined 
with  a  performance  study  of  an  in  vitro  diagnostic  medical  device  that  is 
subject to authorisation pursuant to Article 58(1) of Regulation (EU) 2017/746, 
or is combined with a clinical investigation of a medical device that is subject 
to authorisation according to Article 62 of Regulation (EU) 2017/745. 

By way of derogation from Article 5, the sponsor of a combined study referred 
to in paragraph 1, which is to be conducted in one or more Member States, may 
submit a single application for authorisation.  

The  single  application  referred  to  in  paragraph  2  shall  be  submitted 
electronically  through  the  EU  Portal  to  all  Member  States  in  which  the 
combined  study  is  to  be  conducted  (‘Member  States  concerned’).  Where  a 
combined  study  has  more  than  one  sponsor,  the  sponsors  shall  designate  one 
coordinating sponsor. 

The Member States concerned shall assess the single application by means of a 
coordinated  assessment  procedure  under  the  direction  of  a  reporting  Member 
State chosen  from  among the Member States concerned.  If a  combined  study 
involves  only  one  Member  State,  that  Member  State  shall  be  the  reporting 
Member State. 

The  coordinated  assessment  procedure  shall  include  the  assessment  by  the 
competent authorities and review by ethics committees. During the assessment 
procedure, the Member States concerned may only raise considerations related 
to the following:  

(a) 

the grounds referred to in Article 14a(5) of this Regulation, Article 78(8) 
of  Regulation  (EU)  2017/746  or  Article  74(8)  of  Regulation  (EU) 
2017/745; or  

(b) 

issues  that  would  lead  to  ethics  committee  of  the  Member  State 
concerned issuing a negative opinion. 

6.  Where  the  conclusion  of  the  reporting  Member  State  as  regards  the  area  of 
coordinated assessment is that the conduct of the combined study is acceptable, 
or  acceptable  subject  to  compliance  with  specific  conditions,  that  conclusion 
shall be deemed to be the conclusion of all Member States concerned.  

Notwithstanding  the  first  subparagraph  of  this  paragraph,  a  Member  State 
concerned  may  disagree  with  the  conclusion  of  the  reporting  Member  State 
concerning the area of coordinated assessment but only on one of the following 
grounds,  provided  that  the  corresponding  consideration  was  raised  during  the 
assessment  process  and  the  Member  State  concerned  has  substantiated 
comments that were not sufficiently addressed: 

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(a) 

participation in the combined study would lead to a subject receiving an 
inferior  treatment  than  in  normal  clinical  practice  in  the  Member  State 
concerned;  

(b) 

infringement of its national law; 

(c)  with  regard  to  the  assessment  of  the  medical  device  or  in  vitro  medical 
device,  grounds  referred  to  in  Article  78(8)  of  Regulation  2017/746  or 
Article 74(8) of Regulation (EU) 2017/745, respectively 

7.  Where a Member State concerned disagrees with the conclusion on the basis of 
paragraph  5,  it  shall  communicate  its  disagreement,  together  with  a  detailed 
justification,  through  the  EU  Portal,  to  the  Commission,  to  all  other  Member 
States concerned, and to the coordinating sponsor referred to in paragraph 2.  

8. 

9. 

Each  Member  State  concerned  shall  issue  a  single  decision  as  to  whether  the 
combined study is authorised, whether it is authorised subject to conditions, or 
whether  authorisation  is  refused  and  shall  notify  the  coordinating  sponsor 
referred to in paragraph 2.  

The Commission shall, by means of a delegated act in accordance with Article 
89, amend or supplement, as necessary, the provisions of Chapters II to V, VII, 
XIII, XIV and XVI and Articles 71 and 72 of this Regulation in order to: 

(a) 

(b) 

(a) 

enable a streamlined procedure for an authorisation of combined studies, 
including the coordinated assessment of initial applications, coordinated 
assessment  of  the  request  for  substantial  modifications  and  additions  of 
Member State concerned; 

set  the  requirements  applicable  during  the  conduct  of  the  combined 
studies, including as regards to the specific safety reporting requirements; 

clarify  the  responsibilities  of  the  combined  studies’  sponsors  and 
investigators; 

(b) 

ensure supervision; 

(c) 

determine the functionalities of the EU portal and EU database necessary 
to support application of this Article. 

10.  When doing so, the Commission shall take into consideration, where relevant, 
provisions  of  Chapter  VI  and  Annex  XV  of  Regulation  (EU)  2017/745  or  
Chapter  VI  and  Annexes  XIII  and  XIV  of  Regulation  (EU)  2017/746 
concerning  the  investigational  device(s)  or  device(s)  for  performance  study 
which are covered by the combined study, as applicable.  

Article 14d 

Persons assessing the applications 

Article 9 applies to assessments made under this Chapter.’ 

(14) 

Article 16 is replaced by the following: 

‘Article 16 

Submission of application 

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In order to obtain an authorisation, the sponsor shall submit an application dossier to 
the Member States concerned through the EU portal. The date on which the sponsor 
submitted the application for an authorisation of a substantial modification is referred 
to within this Chapter as the submission date.’; 

(15) 

the following Article 16a is inserted: 

‘Article 16a 

Parallel substantial modification 

1. 

2. 

3. 

The sponsor may submit to the reporting Member State, through the EU portal, 
an application for a parallel substantial modification regarding aspects covered 
by Part I of the assessment report, prior to the notification of a decision on an 
ongoing  assessment  of  a  substantial  modification  in  accordance  with  Article 
19(1) or Article 23(1). 

The sponsor may submit to the same Member State concerned, through the EU 
portal,  an  application  for  a  parallel  substantial  modification  of  an  aspect 
covered  by  Part  II  of  the  assessment  report  prior  to  the  notification  of  a 
decision on an ongoing assessment of a substantial modification in accordance 
with Article 20(5) or Article 23(1) by the same Member State concerned. 

The  reporting  Member  State  or  Member  state  concerned,  as  applicable,  shall 
accept  the  application  for  a  parallel  substantial  modification  if  the  parallel 
substantial  modification  concerns  distinct  and  independent  aspects  of  the 
application  dossier  and  may  be  assessed  concurrently  by  the  same  Member 
State concerned or reporting Member State. 

4.  When scope of the application for the parallel substantial modification covers 
both  Part  I  and  Part  II  of  the  assessment  report,  the  sponsor  shall  seek  the 
agreement of both, the reporting Member State and the relevant Member States 
concerned. The relevant Member State concerned may oppose the agreement if 
the substantial modification concerns aspects of Part II covered by an ongoing 
assessment.’ 

(16) 

Article 17 is amended as follows: 

(a) 

paragraphs 1 and 2 are replaced by the following: 

‘1.  The  reporting  Member  State  for  the  authorisation  of  the  substantial 
modification  shall  be  the  reporting  Member  State  for  the  initial 
authorisation procedure. 

2.  Within four days from the submission date, the reporting Member State 
shall  validate  the  application  and  notify  the  sponsor  through  the  EU 
portal as to whether: 

(a) 

(b) 

(c) 

the substantial modification concerns an aspect covered by Part I of 
the assessment report;  

the  application  dossier  is  complete  in  accordance  with  Annex  II; 
and 

in case of parallel substantial modification to Part I, whether such a 
parallel  substantial  modification  is  acceptable  taking  into  account 
the requirements of Article 16a. 

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When  applicable,  in  the  context  of  a  substantial  modification  of  Part  I, 
the  Member  State  concerned  shall  verify  whether  the  translation  or 
translations in the national language or languages in accordance with the 
requirements  of  Articles  26  and  69  has  or  have  been  submitted  as  a 
substantial modification of Part II. Article 21 applies to the assessment of 
the accuracy of translations.’ 

(b)  paragraph 4 is replaced by the following: 

‘4.  Where  the  reporting  Member  State  finds  that  the  application  does  not 
concern an aspect covered by Part I of the assessment report or that the 
application dossier is not complete or, where applicable, that the parallel 
substantial  modification  is  not  acceptable,  it  shall  inform  the  sponsor 
thereof though  the EU portal  and shall set  a maximum  of four days  for 
the sponsor to comment on the application of to complete the application 
dossier though the EU portal. 

The reporting Member State shall notify the sponsor within 14 days from 
the submission  date,  as  to whether or not  the application complies with 
the  requirements  set  out  in  paragraph  2,  points  (a),  (b),  and  when 
applicable point (c). 

to 

in 

the  second  subparagraph, 

Where the reporting Member State has not notified the sponsor within the 
period  referred 
the  substantial 
modification applied for shall be deemed to concern an aspect covered by 
Part I of the assessment report, the application dossier shall be deemed to 
be  complete  and,  when  applicable,  the  parallel  substantial  modification 
shall be deemed to be acceptable taking into account the requirements of 
Article 16a. 

Where  the  sponsor  has  not  provided  comments  or  completed  the 
application dossier within the period referred to in the first subparagraph, 
the application shall be deemed to have lapsed in all the Member States 
concerned.’ 

(17) 

Article 18 is amended as follows: 

(a) 

paragraphs 3 and 4 are replaced by the following: 

‘3.  The reporting Member State shall submit, through the EU portal, the final 
assessment  report  including  its  conclusions,  to  the  sponsor  and  to  the 
other Member States concerned within 28 days from the submission date.  

For  the  purpose  of  this  Article  and  of  Articles  19  and  23,  the  reporting 
date shall be the date on which the final assessment report is submitted to 
the sponsor and the other Member States concerned. 

4. 

For clinical trials involving more than one Member State the assessment 
process of substantial modification shall include three phases: 

(a) 

an  assessment  phase  performed  by  the  reporting  Member  State 
within  21  days  from  the  submission  date.  The  assessment  phase 
shall  end  when  the  reporting  Member  State  circulates  the  draft 
assessment report;  

(b) 

a  review  phase  performed  within  three  days  from  the  end  of  the 
assessment phase, involving all the Member States concerned, and; 

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(c) 

a  coordination  phase  performed  within  four  days  from  the  end  of 
the review phase. 

During the assessment phase, the reporting Member State shall develop a 
draft  assessment  report  and  circulate  it  to  all  the  Member  States 
concerned. 

During  the review phase, all Member States  concerned shall review the 
application  on  the  basis  of  the  draft  assessment  report  and  shall  share 
considerations for their Member State that are relevant to the application. 

Considerations may only be raised on: 

– 

– 

one or more grounds referred to in Article 19(2) of this Regulation. 

on  matters  that  would  lead  the  ethics  committee  issuing  negative 
opinion. 

During  the  consolidation  phase,  the  reporting  Member  State  shall  take 
due account of the considerations of the other Member States concerned 
when  finalizing  the  assessment  report  and  shall  record  how  the 
considerations  have  been  addressed.  The  reporting  Member  State  shall 
submit  the  final  assessment  report  to  the  sponsor  and  all  the  other 
Member States concerned by the reporting date.’ 

(b)  paragraph 5 is deleted;  

(c) 

paragraph 6 is replaced by the following: 

‘6.  Between  the  validation  date  and  the  reporting  date,  only  the  reporting 
Member  State  may  request  additional  information  from  the  sponsor, 
taking into account the considerations referred to in paragraph 4. 

For  the  purpose  of  obtaining  and  reviewing  this  additional  information 
from  the  sponsor  in  accordance  with  the  third  and  fourth  subparagraph, 
the reporting Member State may extend the period referred to in the first 
subparagraph of paragraph 3 by a maximum of 14 days.  

The sponsor shall submit the requested additional information within the 
period  set  by  the  reporting  Member  State.  This  period  shall  not  extend 
beyond seven days from the receipt of the request. 

Upon receipt of the additional information, the Member States concerned 
shall review any additional information provided by the sponsor and shall 
share  any  unaddressed  considerations  relevant  to  the  application.  The 
review  shall  be  performed  within  a  maximum  of  three  days  from  the 
receipt  of  the  additional  information  and  further  consolidation  shall  be 
performed  within  a  maximum  of  seven  days  from  the  receipt  of 
additional information from the sponsor. When finalising the assessment 
report,  the  reporting  Member  State  shall  take  due  account  of  the 
considerations  of  the  other  Member  States  concerned  and  shall  record 
how the considerations have been dealt with.’; 

(18) 

Article 19 is amended as follows: 

(a) 

paragraphs 1 and 2 are replaced by the following: 

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‘1.  Each  Member  State  concerned  shall  notify  the  sponsor  through  the  EU 
portal as to whether the substantial modification is authorised, whether it 
is authorised subject to conditions, or whether authorisation is refused. 

Notification  shall  be  done  by  way  of  a  single  decision  within  five  days 
from the reporting date. 

Where  the  conclusion  of  the  reporting  Member  State  is  that  the 
substantial  modification 
to 
compliance with specific conditions, that conclusions shall be deemed to 
be the conclusions of the Member State concerned. 

is  acceptable  or  acceptable  subject 

A  substantial  modification  subject  to  condition  may  be  implemented 
unless  the  Member  State  concerned  specified  that  the  condition  is 
suspensive.  Unless  otherwise  specified,  the  fulfilment  of  the  condition 
does  not  require  a  submission  of  a  request  for  another  substantial 
modification. 

Notwithstanding the first subparagraph, a Member State concerned may 
disagree with that conclusion of the reporting Member State only on the 
following grounds, provided that the consideration was raised during the 
process  pursuant  to  Article  18(4)  and  it  considers  that  it  was  not 
sufficiently addressed: 

(a)  when it considers that participation in the clinical trial would lead 
to a subject receiving an inferior treatment than in normal clinical 
practice in the Member State concerned; 

(b) 

infringement of its national law as referred to in article 90. 

2.  Where the Member State concerned disagrees with the conclusion on the 
basis of the second subparagraph, it shall communicate its disagreement, 
together  with  a  detailed  justification,  through  the  EU  portal,  to  the 
Commission, to all Member States and to the sponsor. 

A  Member  State  concerned  shall  refuse  to  authorise  a  substantial 
modification if it disagrees with the conclusion of the reporting Member 
State  as  regards  Part  I  of  the  assessment  report  on  any  of  the  grounds 
referred  to  in  the  second  paragraph    or  where  an  ethics  committee  has 
issued  a  negative  opinion  which,  in  accordance  with  the  law  of  that 
Member  State  concerned,  is  valid  for  the  entire  Member  State.  That 
Member  State  shall  provide  for  an  appeal  procedure  in  respect  of  such 
refusal.’ 

(19) 

Article 20 is amended as follows: 

(a) 

paragraphs 1 and 2 are replaced by the following: 

‘1.  Within  four  days  from  the  submission  of  the  application  dossier,  the 
Member State concerned shall notify the sponsor though the EU portal of 
the following: 

(a)  whether the substantial modification concerns an aspect covered by 

Part II of the assessment report;  

(b)  whether  the  application  dossier  is  complete  in  accordance  with 

Annex II;  

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(c) 

in case of parallel modification to Part I, whether the submission is 
acceptable taking into account the requirements of Article 16a. 

‘2.  Where the Member State concerned has not  notified the sponsor within 
the period referred to in paragraph 1, the substantial modification applied 
for  shall  be  deemed  to  concern  an  aspect  covered  by  Part  II  of  the 
assessment  report  and  the  application  dossier  shall  be  deemed  to  be 
complete and, when applicable, the parallel substantial modification shall 
be  deemed  to  be  acceptable  taking  into  account  the  requirements  of 
Article 16a.’ 

(b) 

in paragraph 3, the two first subparagraphs are replaced by the following: 

‘Where  the  Member  State  concerned  finds  that  the  substantial  modification 
does not concern an aspect covered by Part II of the assessment report or that 
the  application  dossier  is  not  complete,  or,  where  applicable,  that  the  parallel 
substantial  modification  is  not  acceptable,  it  shall  inform  the  sponsor  thereof 
through the EU portal and shall set a maximum of five days for the sponsor to 
comment on the application or to complete the application dossier through the 
EU portal. 

Within  14  days  from  the  submission  date  the  reporting  Member  State  shall 
notify  the  sponsor  as  to  whether  or  not  the  application  complies  with  the 
requirements set out in paragraph 1 points (a), (b), and if applicable, (c).’ 

(c) 

in  paragraph  5,  the  second  and  third  subparagraphs  are  replaced  by  the 
following: 

‘Notification shall be done by way of a single decision within 28 days from the 
submission date. 

A substantial modification subject to condition may be implemented unless the 
Member  State  concerned  specified  that  the  condition  is  suspensive.  Unless 
otherwise specified, a fulfilment of the condition does not require a submission 
of a request for another substantial modification.’ 

(d) 

in paragraph 6, the second, third and fourth subparagraphs are replaced by the 
following: 

‘For  the  purpose  of  obtaining  and  reviewing  this  additional  information  from 
the sponsor, the Member State concerned may extend the period referred to in 
the paragraph 5, second subparagraph, by a maximum of 14 days. 

The sponsor shall submit the requested additional information within the period 
set  by  the  Member  State  concerned,  which  shall  not  exceed  seven  days  from 
the receipt of the request. 

Upon receipt of the additional information, the Member State concerned shall 
complete its assessment within a maximum seven days.’; 

(20) 

in Article 21, paragraph 1 is replaced by the following: 

‘1.  Where a substantial modification relates to aspects covered by Parts I and II of 
the  assessment  report,  the  application  for  an  authorisation  of  that  substantial 
modification shall be validated in accordance with Articles 17 and  20.’; 

(21) 

Article 22 is amended as follows: 

(a) 

paragraph 1 is replaced by the following: 

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‘1.  Each  Member  State  concerned  shall  assess,  for  its  own  territory,  the 
aspects of the substantial modification which are covered by Part II of the 
assessment  report  and  submit,  through  the  EU  portal,  that  report, 
including  its  conclusion,  to  the  sponsor  within  28  days  from  the 
submission  date.  If  the  reporting  Member  State  requested  additional 
information regarding aspects covered by Part I of the assessment report 
as per Article 21(2) in conjunction with Article 18(6), or when a Member 
State  concerned  requests  additional  information  from  the  sponsor 
regarding  Part  II  aspects  of  the  application,  Member  States  concerned 
may extend this period by 14 days.’ 

(b)  paragraph 2 is deleted; 

(c) 

paragraph 3 is replaced by the following: 

‘3.  The sponsor shall submit the requested additional information within the 
period set by the Member State concerned, which shall not exceed seven 
days from the receipt of the request. 

Upon receipt of the additional information, the Member State concerned 
shall complete its assessment within a maximum of seven days from the 
submission of the requested information by the sponsor. 

Where the sponsor does not provide the requested additional information 
within the period set by the Member State concerned the application shall 
be deemed to have lapsed in that Member State. 

The  request  for  additional  information  and  the  additional  information 
shall be submitted through the EU portal.’ 

(22) 

Article 23 is amended as follows: 

(a) 

in paragraph 1, the third subparagraph is replaced by the following: 

‘A  substantial  modification  subject  to  condition  may  be  implemented  unless 
the Member State concerned specified that the condition is suspensive. Unless 
otherwise specified, a fulfilment of the condition does not require a submission 
of a request for another substantial modification.’ 

(b) 

in paragraph 2, the second subparagraph, is replaced by the following: 

’Notwithstanding  the  first  subparagraph,  a  Member  State  concerned  may 
disagree  with  the  conclusion  of  the  reporting  Member  State  only  on  the 
following  grounds,  provided  that  the  consideration  was  raised  during  the 
process  pursuant  to  Article  18(4)  and  it  considers  that  it  was  not  sufficiently 
addressed: 

(a)  when  it  considers  that  participation  in  the  clinical  trial  would  lead  to  a 
subject receiving an inferior treatment than in normal clinical practice in 
the Member State concerned; 

(b) 

infringement of its national law as referred to in Article 90.’ 

(23) 

Article 25 is amended as follows: 

(a) 

paragraph 1 is amended as follows: 

(i) 

in the first subparagraph, point (e) is replaced aby the following: 

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‘(e) 

justification as to why the clinical trial is a minimal-intervention or 
low-intervention clinical trial, in cases where this is claimed by the 
sponsor.’; 

(ii) 

the second subparagraph is replaced by the following: 

‘The list of required documentation and information for Part I is set out 
in Part I of Annex I. The list of required documentation for Part II is set 
out in Part II of Annex I.’; 

(b) 

the following paragraphs 1a, 1b and 1c are inserted: 

‘1a.  The requirements for Part I may be adapted for minimal-intervention or 

low-intervention clinical trials.” 

‘1b.  The  sponsor  shall  use  harmonised  templates,  where  such  templates  are 
available, for the submission of documents for Part II of the application 
dossier necessary for the authorisation of the clinical trial, in accordance 
with the requirements described in Article 7(1) of this Regulation. 

1c.  To  draw  up  and  update,  when  necessary,  harmonised  templates  to  be 
used  by  sponsors,  the  Commission  shall  be  empowered  to  adopt 
implementing  acts  in  accordance  with  Article  88.   The  harmonised 
templates may include standardised sections for documents referred to in 
Article 7(2) and in Annex I.’ 

(c) 

the following paragraph 2a is inserted: 

’2a.  The requirements referred to in paragraph 2 may be adapted for minimal-

intervention and low-intervention clinical trials.’ 

(d) 

the following paragraphs 8 and 9 are added: 

‘8.  An  application  dossier  for  an  authorisation  of  a  clinical  trial  or  for  an 
authorisation  of  a  substantial  modification  may  rely  on  health  data 
accessed under Chapter IV of Regulation (EU) 2025/327 of the European 
Parliament and of the Council*  

9.  National  competent  authorities  and  ethics  committees  shall  ensure  that 
the persons validating or assessing the initial application and substantial 
modification requests only documents which are listed in Part I and Part 
II of Annex I and Annex II.’ 

*  

Regulation  (EU)  2025/327  of  the  European  Parliament  and  of  the 
Council  of  11  February  2025  on  the  European  Health  Data  Space  and 
amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 
2025/327, 5.3.2025. ELI: http://data.europa.eu/eli/reg/2025/327/oj). 

(24) 

the following Chapters IVa and IVb are inserted: 

‘Chapter IVa 

INVESTIGATIONAL MEDICINAL PRODUCT CORE DOSSIER 

Establishment of an investigational medicinal product core dossier 

Article 27a 

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1.  At the time of submission of a clinical trial application referred to in Articles 5 
and 11 the sponsor may request through the EU portal the establishment of an 
investigational  medicinal  product  core  dossier.  To  this  end,  the  sponsor  shall 
provide data and information referred to in point (Ga) of Part I of Annex I. 

2. 

3. 

the 
the  request  for 
The  sponsor  shall  submit 
investigational medicinal product core dossier to all Member States concerned 
of the initial trial. The sponsor may extend this request to other Member States 
than the Member States concerned. The reporting Member State of the initial 
clinical trial shall become the depositary Member State. 

the  establishment  of 

The  depositary  Member  State  shall  verify  the  completeness  and  suitability  of 
the core dossier for the purposes of the initial clinical trial. At the latest by the 
time when the conclusion of the assessment of Part I is due in accordance with 
Article 6(3) the depositary Member State shall notify the sponsor and the other 
core  dossier  competent  Member  States  through  the  EU  portal  of  the 
establishment of the investigational medicinal products core dossier where the 
assessment is positive.  

4. 

The investigational  product  core dossier shall be relied upon by the reporting 
Member State and the Member States concerned in the process of authorising 
the initial clinical trial referred to in paragraph 1.  

5.  Once  established,  the  investigational  medicinal  product  core  dossier  shall  be 
referred  to  in  all  subsequent  applications  concerning  the  clinical  trial  in  the 
context  of  which  the  investigational  medicinal  products  core  dossier  was 
established and any other corresponding clinical trial.  

Article 27b 

Maintenance and changes of the investigational medicinal products core dossier 

1. 

The  sponsor  shall  keep  the  investigational  medicinal  product  core  dossier 
updated and shall review it at least once per year. When the sponsor identifies a 
necessity  to  update  the  investigational  products  core  dossier,  paragraph  2 
applies. 

2.  When  new  information,  relevant  to  maintain  the  suitability  and  completeness 
of  an  established  investigational  product  core  dossier  becomes  known  to  the 
sponsor, the sponsor shall submit to the depositary Member State, through the 
EU portal, a request for a change of the investigational medicinal product core 
dossier.  

3. 

In  case  of  a  new  application  for  an  authorisation  of  a  new  corresponding 
clinical trial, the reporting Member State of that clinical trial together with the 
depositary  Member  State  shall  assess  the  suitability  of  the  investigational 
product core dossier for the purpose of the authorisation of the trial application, 
that is; 

(a)  whether  the  investigational  product  core  dossier  is  complete  as  regards 
the  information  on  the  characteristics  and  knowledge  about  the 
investigational medicinal products;  

(b) 

if  appropriate,  the  compliance  with  the  requirements  concerning  the 
manufacturing and import of investigational medicinal products set out in 
Chapter IX; 

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(c)  whether  the  investigator’s  brochure  and  the  IMPD  is  adequate  and 
complete  for  the  scope  of  use  as  proposed  by  the  sponsor  in  the 
application in accordance point Ga, Part I of Annex I.  

The  reporting  Member  State  of  the  corresponding  clinical  trial  shall 
communicate the results of its assessment to the depositary Member State.  

If the investigational product core dossier does not contain all the information 
necessary for the authorisation of the clinical trial, the reporting Member State 
may request the sponsor to change the investigational product core dossier. 

The  sponsor  shall  in  such  situations  request  a  change  of  the  investigational 
medicinal product core dossier in accordance with paragraph 2. 

4.  After receiving the request  for a change to  the  core dossier, independently of 
whether a change is submitted in the context of an assessment of an application 
related  to  a  corresponding  clinical  trial  or  independently,  the  depositary 
Member  State  shall  verify  whether  the  core  dossier,  once  changed,  will 
continue to fulfil the requirements listed in paragraph 3 points (a), (b) and (c). 
The  Member  State  concerned  with  the  core  dossier  shall  not  duplicate  the 
assessment of the depositary Member State. The depositary Member State may 
consult the Member State concerned as appropriate.  

5. 

6. 

If a request for a core dossier change is submitted in the context of an ongoing 
assessment related to a corresponding clinical trial, the timeline for change of 
the core dossier shall allow for timely approval of the clinical trial.  

The sponsor shall assess whether a change to the investigational product core 
dossier  makes 
in 
corresponding clinical trials that are ongoing.  

to  submit  a  substantial  modification 

it  necessary 

Article 27c 

Procedural aspects related to the establishment and maintenance of the investigational 
medicinal products core dossier 

The  Commission  shall  set  out  the  detailed  rules  governing  the  submission  of  a 
request  for  the  establishment  of  an  investigational  product  core  dossier,  its 
assessment and maintenance by means of implementing acts, including the rules for 
cooperation  between  the  core dossier  competent  Member  States  and  the  change  of 
depositary  Member  State.  Those  implementing  acts  shall  be  adopted  in  accordance 
with the examination procedure referred to in Article 88.”  

Chapter IVb 

REGULATORY SANDBOXES AND USE OF AI 

Article 27d 

Regulatory sandbox 

1. 

The  Commission  may,  pursuant  to  the  procedure  set  out  in  paragraph  7, 
establish  and  operate  a  regulatory  sandbox  at  Union  level  that  provides  a 
controlled and time-limited framework to enable, under real-world conditions, 
the  testing  of  innovative  approaches  in  clinical  trials  to  which  the  full 

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2. 

3. 

application    of  certain  requirements  of  this  Regulation  is  not  possible  or 
appropriate and which therefore may require adaptations.  

The  regulatory  sandbox  under  this  Regulation  may  encompass  approaches  to 
the  authorisation  and  conduct  of  the  clinical  trials  and  where  appropriate, 
maybe  be  implemented  in  coordination  and  synergies  with  the  regulatory 
sandboxes  established  pursuant  to  Regulation  (EU)  2024/1689  with  full 
involvement  of  competent  authorities  supervising 
the  sandbox  under 
Regulation  (EU)  2024/1689  and  in  accordance  with  the  relevant  procedures 
and rules for participating in those AI regulatory sandboxes. 

The  activities  within  a  regulatory  sandbox  shall  take  place  pursuant  to  a 
specific  plan,  for  eligible  clinical  trials,  which  may  be  conducted  under 
enhanced regulatory oversight of the Member States concerned. The plan shall 
clearly  identify  the  requirements  of  this  Regulation  that  are  temporarily 
adapted or derogated from in the sandbox and that may relate to, as necessary, 
to  source  data  and  documentation  requirements,  recruitment  and  informed 
consent  procedures, monitoring and reporting requirements, trial  design  rules, 
investigational  medicines  handling 
rules,  site 
requirements.  The  plan  shall  also  identify  the  roles  and  responsibilities  of 
sponsors, investigators, and manufacturers.   

rules,  safety 

reporting 

4.  A regulatory sandbox may be established only  if the following conditions are 

met:    

(a) 

it is not possible to authorise or conduct a clinical trial in full compliance 
with the requirements of this Regulation due to innovative approaches in 
the clinical trial or due to the specificity of the investigational medicinal 
product;    

(b) 

the  approaches  referred  to  in  point  (a)  are  expected  to  contribute  to  at 
least one of the following objectives:   

(i) 

increasing the robustness of the data generated in the trial;  

(ii) 

considerably  decreasing  clinical  trial  length,  and  increasing  the 
efficiency of the clinical trial; 

(iii)  enabling  new  technologies  and  approaches  in  the  development  of 
medicinal  products  that  have  the  potential  to  positively  and 
distinctively  contribute 
to  better  prevention,  diagnosis,  and 
treatment,  as  well  as  increase  adherence  to  treatment  plans  or 
improve the efficiency of the provision of health care;    

 (c) 

the  sandbox  provides  safeguards  to  ensure  the  safety,  well-being,  and 
fundamental  rights  of  clinical  trial  participants,  data  robustness,  and 
maintained integrity of the clinical trials within the sandbox. 

5. 

The regulatory sandbox shall not affect the supervisory or corrective powers of 
the Member States concerned and shall operate under the direct supervision of 
the competent authorities in the Member State concerned for activities that take 
place on its territory.  

6. 

Before  setting  up  a  sandbox,  the  Commission  shall  request  an  opinion  of  the 
CTAG.   

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7. 

The  Commission  may  establish  a  regulatory  sandbox  by  means  of 
implementing  acts,  after  taking  into  consideration  opinions  referred  to  in 
paragraph 6. Those implementing acts shall be adopted in accordance with the 
examination procedure referred to in Article 88.  

8.  Member  States  shall  notify  the  Commission  of  any  risk  to  health  and  safety  or 
fundamental  rights  or  integrity  and  robustness  of  data  identified  during  the 
operation  of  a  sandbox.  In  these  cases,  the  Commission  may,  by  means  of 
implementing acts, suspend or revoke a regulatory sandbox.   

8.  Without prejudice to Article 114(1) of [Regulation (EU) …/… of the European 
Parliament  and  the  Council  [reference  to  be  added  after  adoption  cf. 
COM(2023)  193  final],  where  in  the  context  of  a  regulatory  sandbox  under 
Article  113  of  Regulation  (EU)  …/…  of  the  European  Parliament  and  the 
Council  [reference  to  be  added  after  adoption  cf.  COM(2023)  193  final]  is 
considered that new regulatory approaches in clinical trial are necessary for the 
product  development,  the  Commission  may  consider  to  establish  a  regulatory 
sandbox  under  this  Regulation  to  complement  the  regulatory  sandbox 
established  under  Regulation  (EU)  …/…  of  the  European  Parliament  and  the 
Council [reference to be added after adoption cf. COM(2023) 193 final]. 

Article 27e   

Use of Artificial Intelligence in Clinical Trials   

1. 

2. 

For those clinical trials where the sponsor plan to use   AI models or systems, 
the  sponsor  shall  evaluate  the  benefits  and  risks  related  to  patient  safety  and 
data robustness of the use of the AI in the context of a specific clinical trial for 
a specific purpose taking into account the guidelines laid down in Article 37 of 
Regulation [...] [Biotech Act].   

The sponsor shall provide information in the protocol on the specific purpose 
of  the  use  of  AI  models  or  systems  and  the  description  of  the  process  in  the 
context of the specific clinical trial.  

3.  When  the  investigation  of  a  medicinal  product  in  a  clinical  trial  is  combined 
with  a  performance  study  of  an  AI  in  vitro  diagnostic  medical  device  or  a 
clinical investigation of an AI medical device, the provisions of Article 14 on 
coordinated assessment for authorising combined studies shall apply. 

4. 

In  cooperation  with  the  CTAG  and,  where  appropriate,  the  Medical  Device 
Coordination  Group,  the  Artificial  Intelligence  Board,  the  Agency  shall 
develop guidelines referred to in paragraph 1 of this Article.   

**  Proposal  for  a  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND 
OF  THE  COUNCIL  laying  down  Union  procedures  for  the  authorisation  and 
supervision  of  medicinal  products  for  human  use  and  establishing  rules 
governing  the  European  Medicines  Agency,  amending  Regulation  (EC)  No 
1394/2007  and  Regulation  (EU)  No  536/2014  and  repealing  Regulation  (EC) 
No  726/2004,  Regulation  (EC)  No  141/2000  and  Regulation  (EC)  No 
1901/2006, COM/2023/193final 

(25) 

Article 28 is amended as follows: 

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(a) 

paragraph 2 is deleted.  

(b) 

in paragraph 3, the last sentence is deleted.  

(26) 

in Article 29(1), the following subparagraph is added:  

‘The communication in the context of an interview between the investigator and the 
subject or the investigator and the subject and its legally designated representative, as 
applicable, may be done remotely through use of electronic means. The record of the 
informed consent procedure may have an electronic form and shall be signed relying 
on electronic identification means complying with Regulation (EU) No 910/2014 of 
the European Parliament and of the Council* or the equivalent standards. 

*  Regulation  (EU)  No 910/2014  of  the  European  Parliament  and  of  the  Council  of 
23 July 2014 on electronic identification and trust services for electronic transactions 
in 
internal  market  and  repealing  Directive  1999/93/EC,  OJ  L  257, 
28.8.2014.ELI: http://data.europa.eu/eli/reg/2014/910/oj.’’ 

the 

(27) 

in Article 30(3), point (c) is replaced by the following:  

‘(c) 

the clinical trial is a minimal-intervention clinical trial;’ 

(28) 

(29) 

(30) 

in Article 31(1), point (e) is deleted;  

in Article 32 (1), point (e) is deleted;  

in Article 33, the following second paragraph is inserted:  

’Women  who  become  pregnant  or  begin  breastfeeding  while  participating  in  a 
clinical  trial  shall  not  be  automatically  excluded  from  participation  in  the  clinical 
trial.’ 

(31) 

in Article 41, the following paragraph 5 is added:  

’5.  Reporting  requirements  of  adverse  events  and  serious  adverse  events  for 
minimal-intervention and low-intervention clinical trials shall be simplified by 
applying a  risk-based approach. Any such adaptation should be  clearly stated 
and justified in the protocol by the sponsor.: 

(32) 

in Article 48, point (a) is replaced by the following:  

‘(a)  whether the clinical trial is a minimal-intervention or low-intervention clinical 

trial;’: 

(33) 

the following Article 50a is inserted:  

’Article 50a  

Delivery of investigational and auxiliary medicinal products through a dispensing pharmacy, 
an authorised person or directly to the subject  

When justified in the protocol, the delivery of investigational medicinal products and 
auxiliary  medicinal  products  to  the  clinical  trials  subjects  may  be  ensured  at  a 
distance under the supervision of the investigator. 

In  case  of  a  minimal-intervention  and  a  low-intervention  clinical  trial,  the 
distribution  of  the  investigational  medicinal  products  can  be  ensured  in  a  Member 

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State  where  the  clinical  trial  has  been  authorised,      under  the  responsibility  of  the 
investigator,  through  the  dispensing  pharmacies  or  by  persons  authorised  to  supply 
medicinal products to thesubject. 

The  protocol  and  investigator’s  brochure  shall  describe  the  arrangements  for  direct 
delivery  to  subjects  or  through  dispensing  pharmacies  or  persons  authorised  to 
supply to the patients, including the roles and responsibilities of all parties involved 
and procedures for secure handling, storage. 

The  direct  delivery  to  subjects  shall  comply  with  the  guidelines  referred  to  in 
paragraph 1 of Article 63a.’: 

(34) 

in Article 51(1), first subparagraph is replaced by the following:  

’Investigational medicinal products shall be traceable. They shall be stored, returned 
and/or destroyed as appropriate and proportionate to ensure the safety of the subject 
and  the  reliability  and  robustness  of  the  data  generated  in  the  clinical  trial,  in 
particular,  taking  into  account  whether  the  investigational  medicinal  product  is  an 
authorised  investi gational  medicinal  product,  and  whether  the  clinical  trial  is  a 
minimal-intervention or low-inter vention clinical trial.’; 

(35) 

in Article 53(2), the first sentence is replaced by the following:  

’The  sponsor  shall  submit  to  the  Member  States concerned,  through  the  EU  portal, 
inspection  reports  of  third  country  authorities  concerning  the  clinical  trial  and 
relevant to subject safety .’ 

(36) 

in Article 57, the first subparagraph is replaced by the following: 

’The sponsor and the investigator shall keep a clinical trial master file. The clinical 
trial  master  file  shall  at  all  times  contain  the  essential  documents  relating  to  that 
clinical trial which allow verification of the conduct of a clinical trial and the quality 
of  the  data  generated,  taking  into  account  all  characteristics  of  the  clinical  trial, 
including  in  particular  whether  the  clinical  trial  is  a  minimal-intervention  or  low-
intervention clinical trial.’; 

(37) 

Article 61 is amended as follows:  

(a) 

paragraph 6 is replaced by the following:  

‘6.  Member States shall make the processes set out in paragraph 5 subject to 
appropriate  and  proportionate  requirements  to  ensure  subject  safety  and 
reliability and robustness of the data generated in the clinical trial  while 
taking into account the guidelines referred to in paragraph 7. They shall 
subject the processes to regular inspections.’; 

(b) 

the following paragraph 7 is added:  

‘7.  The  inspection  working  groups  referred  to  in  Article  142,  point  (k)  of 
Regulation  (EU)  …/…  of  the  European  Parliament  and  the  Council 
[reference  to  be  added  after  adoption  cf.  COM(2023)  193  final]*,  in 
agreement  with  the  Commission,  may  draw  up  guidelines  on  general 
principles applicable to the processes set out in paragraph 5, including for 
auxiliary  medicinal  products,  and  revise  them  as  necessary  in  order  to 
take account of technical and scientific progress. 

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*Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND 
OF  THE  COUNCIL  laying  down  Union  procedures  for  the  authorisation  and 
supervision  of  medicinal  products  for  human  use  and  establishing  rules 
governing  the  European  Medicines  Agency,  amending  Regulation  (EC)  No 
1394/2007  and  Regulation  (EU)  No  536/2014  and  repealing  Regulation  (EC) 
No  726/2004,  Regulation  (EC)  No  141/2000  and  Regulation  (EC)  No 
1901/2006, COM/2023/193final.’ 

(38) 

in Article 63, paragraph 4 is replaced by the following: 

‘4.  The  Member  States  shall  ensure  compliance  with  the  requirements  of  this 
Article by means of inspections. Articles 188, with exception of its paragraph 3 
and 4, and 189 of Directive (EU) …/… [reference to be added after adoption 
cf.  COM(2023)  192  final]*  and  article  52  of  Regulation  (EU)  …/…  of  the 
European Parliament and the Council [reference to be added after adoption cf. 
COM(2023) 193 final]** apply mutatis mutandis. 

* Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE 
COUNCIL  on  the  Union  code  relating  to  medicinal  products  for  human  use,  and 
repealing Directive 2001/83/EC and Directive 2009/35/EC COM/2023/192final 

** Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL laying down Union procedures for the authorisation and supervision 
of medicinal products for human use and establishing rules governing the European 
Medicines  Agency,  amending  Regulation  (EC) No 1394/2007  and Regulation  (EU) 
No  536/2014  and  repealing  Regulation  (EC)  No  726/2004,  Regulation  (EC)  No 
141/2000 and Regulation (EC) No 1901/2006, COM/2023/193final’ 

(39) 

the following Article 63a is inserted:  

’Article 63a 

Distribution 

1. 

The distribution of investigational  medicinal shall comply with  standards that 
shall ensure their quality and integrity. The Commission shall adopt delegated 
acts  supplementing  this  Regulation  by  determining  the  standards  of  good 
distribution  practices  for  investigational  and  auxiliary  medicinal  products 
taking  into  account  the  input  of  the  inspection  working  groups  referred  to  in 
Article  142,  point  (k)  of  Regulation  (EU)  …/…  of  the  European  Parliament 
and  the  Council  [reference  to  be  added  after  adoption  cf.  COM(2023)  193 
final], and update them if necessary to take account of scientific and technical 
progress.  

2.  Where the competent authority of the Member State considers it necessary, in 
particular  where  there  are  grounds  for  suspecting  non-compliance  with  the 
requirements  of  this  Article,  it  may  carry  out  inspections  to  verify  the 
compliance. 

3.  Arrangements  for  inspections  referred  to  in  Article  63(1)  apply  mutatis 
mutandis  to  inspections  of  good  distribution  practices  for  investigational  and 
auxiliary medicinal products.’; 

(40) 

in Article 76, paragraph 3 is replaced by the following:  

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‘3.  Member States shall not require any additional use of the system referred to in 
paragraph 1 from the sponsor for minimal or low-intervention clinical trials, if 
any possible damage that could be suffered by a subject resulting from the use 
of the investigational medicinal product in accordance with the protocol of that 
specific  clinical  trial  on  the  territory  of  that  Member  State  is  covered  by  the 
applicable compen sation system already in place.’; 

(41) 

Article 78 is amended as follows:  

(a) 

paragraph 1 is replaced by the following: 

’1.  The national competent authorities shall organize inspections in order to 

supervise compliance with this Regulation.  

Member  States  shall  appoint  inspectors  to  perform  the  inspections  in 
order to supervise compliance with this Regulation. 

The  competent  authority  of  the  Member  State  shall  have  in  place  a 
system of supervision that shall include the following measures: 

(a) 

announced, 
inspections; 

and  where 

appropriate,  unannounced  on-site 

(b) 

remote inspections conducted where justified; 

(c) 

(d) 

compliance control;  

the effective follow up of the measures referred to in points (a), (b) 
and (c).’; 

(b) 

 aragraph 6 is replaced by the following: 

“6.  Following  an  inspection,  the  Member  State  under  whose  responsibility 
the  inspection  has  been  conducted,  shall  draw  up  an  inspection  report. 
That  Member  State  shall  make  the  inspection  report  available  to  the 
inspected  entity  and  the  sponsor  of  the  relevant  clinical  trial  and  shall 
submit the inspection  report through the EU portal within 90 days after 
conducting the inspection.”; 

(c) 

 paragraphs 8, 9 and 10 are added: 

‘8.  Upon  a  request  by  one  or  more  competent  authorities  of  the  Member 
State, the inspection referred to in paragraph 1 may be carried out jointly 
by  the  inspectors  from  more  than  one  Member  State  and  the  inspectors 
from the Agency. 

9.  Member States may delegate to another Member State or the Agency the 
conduct  of  a  good  clinical  practice  inspection.  The  Commission  may 
adopt  a  delegated  act  in  accordance  with  Article  89  to  supplement  this 
Regulation by laying down the procedures applicable to joint inspections 
and delegation of inspections.  

10.  This  Article  does  not  apply  to  the  good  manufacturing  practice 
inspections  and  the  good  distribution  practices  inspections  related  to 
application  of  this  Regulation,  in  accordance  with  Articles  63  and  63a 
respectively.’; 

(42) 

Article 79 is replaced by the following:  

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’Article 79 

Union controls 

1. 

The Commission may conduct controls in order to verify: 

(a)  whether  the  Member  States  correctly  supervise  compliance  with  this 

Regulation; 

(b)  whether regulatory system applicable to clinical trials conducted outside 
the Union ensures that the clinical trials references in the applications for 
marketing  authorisations  in  the  Union  are  designed,  implemented  and 
reported  on  what  good  clinical  practice  and  ethical  principle  are 
concerned,  on  the  basis  of  principles  that  are  equivalent  to  the  ones 
established in this Regulation; 

(c)  whether  the  regulatory  system  applicable  to  clinical  trials  conducted 
outside  the  Union  ensures  that  Article  25(5)  of  this  Regulation  is 
complied with . 

1a. 

In  order  to  perform  the  Union  controls  referred  to  in  paragraph  (1)  point  (a), 
the  Commission  may  verify  whether  competent  authorities  and  ethics 
committees  have  in  place  adequate  and  effective  mechanisms  to  ensure 
compliance  with  this  Regulation  as  regards  in  particular  the  requirements 
related to:  

(a) 

(b) 

validation of the clinical trial  application as referred to  in  Articles 5(3), 
17(2) and Article 20; 

scientific  and  ethical  review  as  referred  to  in  Article  4,  Articles  6(1), 
7(1), 8, 9 and 10, assessment of substantial modifications as referred to in 
Articles 17 to 22, safety assessment referred to in Article 44; 

(c) 

communication and coordination with other Member States as referred to 
in Articles 5 to 8, Article 14, Article 17 to 19, Article 22 and 23; 

(d)  manufacturing  and  import  of  investigational  medicinal  products  as 

referred to in Articles 61 and 63(4); 

(e) 

application of corrective measures and penalties as referred to in Article 
77 and 94;  

(f) 

conduct inspections as referred to in Articles 78, 63 and 63a. 

2. 

The  Commission  shall  organise  the  controls  referred  to  in  paragraph  1  in 
cooperation with the national authorities and shall carry them out in a manner 
that avoids unnecessary administrative burden.  

3.  When performing the controls referred to in paragraph 1, the Commission shall 

consult the relevant best practices.  

4. 

The Commission, in carrying out the controls referred to in paragraph 1, may 
be supported by experts from the competent authorities or ethics committees.  

5. 

Following each control, the Commission shall:  

(a) 

(b) 

prepare  a  draft  report  on  the  findings  and,  where  appropriate,  include 
recommendations addressing the shortcomings identified;  

send a copy of the draft report referred to in point (a) to the clinical trials 
national authority concerned for its comments;  

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(c) 

take the comments referred to in point (b) into account in preparing the 
final report; and  

(d) 

submit the final report through the EU portal.”; 

(43) 

the following Article 79a is inserted:  

’Article 79a  

Obligations as regards Union controls 

Member States shall cooperate with the Commission in respect of the performance of 
the Union controls referred to in Article 79 (1). In particular, they shall:  

(a) 

ensure that the necessary technical assistance and the relevant documentation, 
upon justified request, is being provided to the Commission as well as provide 
any other support that the Commission requests to enable it to perform controls 
efficiently  and  effectively,  including  facilitating access  to  all  premises  or  any 
part  thereof,  to  personnel  (interviews)  and  data,  including  IT  systems  of  the 
competent authority that is relevant for the execution of their duties.  

(b) 

take  appropriate  follow-up  measures  to  remedy  the  shortcomings  identified 
through those Commission controls;’ 

(44) 

Article 81 is amended as follows: 

(a) 

paragraph 2 is replaced by the following:  

’2.  The EU database shall be established to enable cooperation between the 
competent authorities of the Member States concerned to the extent that 
it  is  necessary  for  the  application  of  this  Regulation  and  to  search  for 
specific  clinical  trials.  It  shall  also  enable  communication  between 
sponsors  and  Member  States  concerned  and  reporting  Member  State  as 
appropriate for the purpose of swift regulatory procedures. It shall enable 
sponsors  to  refer  to  previous  submissions  of  an  application  for 
authorisation of a clinical trial or a substantial modification. It shall also 
enable citizens of the Union to have access to clinical information about 
medicinal products. To this end all data held in the EU database shall be 
in an easily searchable format, all related data shall be grouped together 
by way of the EU trial number, and hyperlinks shall be provided to link 
together related data  and documents held  on the  EU database  and other 
databases managed by the Agency.’; 

(b)  paragraph 9 is replaced by the following:  

’9.  The sponsor shall permanently update in the EU database information on 
any changes to the clinical trials which are not substantial modifications 
but are relevant for the supervision of the clinical trial. The sponsor shall 
also  update  the  EU  portal  to  satisfy  the  condition  to  which  an 
authorisation  decision  is  subject  to.  An  update  may  trigger  a  corrective 
measure  from  the  reporting  Member  State  or  the  Member  State 
concerned  requiring  from 
to  submit  a  substantial 
the  sponsor 
modification concerning this change. The Member State concerned may 
issue such corrective measure within 7 days from the date of the update. 
The  sponsor  shall  submit  the  substantial  modification  within  period 
defined in the corrective measure by the Member State.’; 

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(45) 

Article 83 is replaced by the following:  

‘Article 83 

Competent authorities and ethics committees 

1.  Member States shall designate one national contact point to which they confer 
responsibility  for  the  implementation  and  practical  application  of  this 
Regulation. The Commission shall publish a list of national contact points.  

2. 

Each  Member  State  shall  communicate  the  contact  point  referred  to  in 
paragraph  1  to  the  Commission.  Member  States  shall  ensure  that  competent 
authorities and ethics committees:  

(a) 

have the necessary powers to perform all the necessary regulatory actions 
and inspections, pursuant to this Regulation. 

(b)  have,  or  have  access  to,  a  sufficient  number  of  suitably  qualified  and 
experienced  personnel,  human  and  financial  resources,  operational 
capacity,  and  expertise,  including  technical  expertise,  for  the  effective 
and efficient performance of their tasks they have been made responsible 
for pursuant to this Regulation.’; 

(46) 

the following Article 83a is inserted:  

’Article 83a  

Communication and coordination between competent authorities and between ethics 
committees  

1.  Where  more  than  one  competent  authority  and  ethics  committee  are 
responsible  for  performing  regulatory  activities  or  inspections  in  a  Member 
State for the purpose of applying this Regulation, Member States shall ensure 
efficient  and  effective  coordination  among  all  the  competent  authorities  and 
ethics  committees  concerned  in  order  to  guarantee  the  consistency  and 
effectiveness  of  the  regulatory  activities  or  inspections  performed  on  their 
territory.  

2.  Within  those  Member  States,  the  competent  authorities  shall  cooperate  with 
each other. They shall communicate information to each other for the effective 
implementation of the regulatory activities and inspections provided for in this 
Regulation.’; 

(47) 

Article 85 is replaced by the following:  

‘Article 85 

Clinical Trials Coordination and Advisory Group 

1.  A  Clinical  Trials  Coordination  and  Advisory  Group  (CTAG)  is  hereby 

established. 

2. 

Each  Member  State  shall  appoint  to  the  CTAG,  for  a  three-year  term  which 
may be renewed once, one member and one alternate each with expertise in the 
field  of  clinical  trials.  The  members  of  the  CTAG  shall  be  chosen  for  their 
competence and experience in  the field  of clinical  trials.  They shall represent 
the  competent  national  authorities  and  the  ethics  committees  of  the  Member 

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3. 

4. 

States.  The  names  and  affiliations  of  members  and  alternates  shall  be  made 
public  by  the  Commission.  The  alternates  shall  represent  and  vote  for  the 
members in their absence.  

For the purpose of the fulfilment of their tasks, CTAG members shall be able 
to rely on the contribution of experts from national competent authorities and 
ethics  committees.  These  experts  shall  participate  in  CTAG  meetings  where 
relevant. 

The CTAG shall use its best endeavors to reach consensus. If such consensus 
cannot  be  reached,  the  CTAG  shall  decide  by  a  majority  of  its  members. 
Members  with  diverging  positions  may  request  that  their  position  and  the 
grounds on which they are based are recorded. 

5. 

The CTAG shall in particular have the following tasks: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

to support the exchange of information between the Member States and 
the  Commission  on  the  experience  acquired  with  regard  to  the 
implementation of this Regulation; 

to  assist  the  Commission  in  providing  the  support  referred  to  in  the 
second paragraph of Article 84; 

to  prepare  recommendations  on  criteria  regarding  the  selection  of  a 
reporting Member State; 

to provide strategic steering on a common approach for the application of 
this Regulation and on the support of the clinical trials ecosystem in the 
Union; 

to contribute to the development of guidance aiming to ensure effective 
and harmonised implementation of this Regulation.  

to contribute to the development of guidelines on the use of the artificial 
intelligence  models  and  systems  in  clinical  trials  in  accordance  with 
Article [xx] Regulation (EU) …/… [European Biotech Act]*; 

to  provide  advice,  either  of  its  own  initiative  or  at  the  request  of  the 
Commission, in the assessment of any issue related to the implementation 
of this Regulation; 

(h) 

to contribute to harmonised administrative practice with regard to clinical 
trials in the Member States; 

(i) 

to provide a recommendation before setting up a regulatory sandbox. 

6. 

7. 

8. 

The CTAG shall be chaired by a representative of the Commission. The chair 
shall not take part in votes of the CTAG. 

The  CTAG  may  issue  recommendations  and  opinions  on  matters  related  to 
clinical trials and shall endorse any guidance related to the application of this 
Regulation.  The  Commission  shall  publish  the  guidelines  endorsed  by  the 
CTAG. 

The CTAG shall meet at regular intervals and whenever the situation requires, 
on a request from the Commission or a Member State. Any item of the agenda 
of the meeting shall be placed at the request of the Commission or a Member 
State. 

9. 

The secretariat shall be provided by the Commission. 

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10.  The CTAG shall draw up its rules of procedure. The rules of procedure shall be 

made public. 

(48) 

Article 93 is replaced by the following:  

’Article 93 

Data protection 

1.  When  carrying  out  their  tasks  pursuant  to  this  Regulation,  sponsors  are 
required  to  process  personal  data,  including  genetic  data  or  data  concerning 
health  for the following purposes: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

for the submission of applications in accordance with  Articles 5, 11, 14 
and 16; 

to  perform  research  activities  in  the  context  of  a  clinical  trial  in 
accordance  with  the  protocol  as  authorised  by  the  national  competent 
authorities in accordance with point D, Part I of Annex I; 

to perform safety operations and reporting in accordance with Articles 41 
to 43 and 52 to 54; 

to  record,  process,  handle  and  store  information  in  accordance  with 
Article 56; 

to perform archiving in accordance with Article 58;  

to submit to the EU portal the summary of the results of the clinical trial, 
the  lay  summary,  the  clinical  study  report  and,  where  applicable,  raw 
data, in accordance with Article 37(4). 

2.  When  carrying  out  their  tasks  pursuant  to  this  Regulation,  investigators  are 
required  to  process  personal  data,  including  genetic  data  or  data  concerning 
health for the following purposes: 

(a) 

to  perform  research  activities  in  the  context  of  a  clinical  trial  in 
accordance  with  the  protocol  as  authorised  by  the  national  competent 
authorities in accordance with point D, Part I, Annex I; 

(b) 

to perform safety reporting in accordance with Articles 41 and 54; 

(c) 

to  record,  process,  handle  and  store  information  in  accordance  with 
Article 56;  

(d) 

to perform archiving in accordance with Article 58. 

3. 

Sponsors  and  investigators  shall  make  available  personal  data,  including 
genetic data or data concerning health: 

(a) 

(b) 

to  the  competent  authorities  of  the  Member  States  for  the  purposes  of 
oversight activities, including inspections, in accordance with Article 78; 

to  the  Commission  for  the  purposes  of  controls,  in  accordance  with 
Article 79. 

4. 

For  the  processing  assessment  leading  to  the  authorisation  of  clinical  trial 
this  Article,  sponsors  and 
applications  and  operations  referred 

in 

to 

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5. 

6. 

7. 

8. 

investigators  are  controllers  within  the  meaning  of  Article  4(7)  of  Regulation 
(EU) 2016/679. 

Personal  data,  including  genetic  data  or  data  concerning  health,  shall  be 
retained as long as required pursuant to Article 58 and in accordance with the 
conditions laid down therein. 

Personal data collected and processed in accordance with this Regulation may 
be  further  processed  by  the  same  controller  for  the  purposes  of  other  clinical 
trials conducted under this Regulation, or for scientific research with the aim of 
protecting  public  health,  improving  standard  of  care  and  fostering  the 
innovation capacity of European medical research.  

By derogation from Article 9(4) of Regulation (EU) 2016/679, Member States 
may  not  maintain  or  introduce  further  conditions,  including  limitations,  with 
regard  to  the  processing  of  personal  data,  including  genetic  data  or  data 
concerning health in the context of clinical trials carried out in accordance with 
this Regulation. 

Processing  of  personal  data  referred  to  in  this  Article  shall  be  subject  to 
appropriate  technical  and  organisational  measures  to  ensure  the  protection  of 
the rights and freedoms of data subject. In particular, the controller shall obtain 
informed  consent  of  the  subject  in  accordance  with  Article  29  of  this 
Regulation.  The  controllers  shall  also  apply  confidentiality  rules  concerning 
access  to  records  and  personal  data  of  subjects  and  apply  further  safeguards 
that are appropriate for a specific clinical trial as requested in point D, Part I of 
Annex I (ak), (al), (am). 

(49) 

Article 97 is replaced by the following: 

“Article 97 

Review 

Five years after the date referred to in  Article 99, second subparagpah, and every ten 
years  thereafter,  the  Commission  shall  present  a  report  to  the  European  Parliament 
and to the Council on the application of this Regulation. That report shall include an 
assessment of the impact that the Regulation has had on scientific and technological 
progress,  comprehensive  information  on  the  different  types  of  clinical  trials 
authorised  pursuant  to  this  Regulation,  and  the  measures  required  in  order  to 
maintain  the  competitiveness  of  European  clinical  research.  The  report  shall  also 
assess  progress  made  by  monitoring  as  a  key  performance  indicator  the  number  of 
addition multinational clinical trials authorised in the Union over the 5-year period of 
the reporting, compared to the average number of such clinical trials authorised per 
year in the Union as of 2025;  

The  Commission  shall,  if  appropriate,  present  a  legislative  proposal  based  on  that 
report in order to update the provisions set out in this Regulation” 

(50 

in Article 98, paragraph 1 is replaced by the following: 

‘1.  This Regulation, as applicable on [Publication Office: please insert the date of 
the  day  before  the  date  of  application  of  Biotechnology  Regulation]  shall 
continue to apply to the procedures for authorisation, substantial modification 

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of  addition  of  a  Member  State  concerned  of  a  clinical  trial  where  the  request 
for  the  authorisation  has  been  submitted  before  the  date  of  entry  into 
application as referred in Article 67(3), point (a), of Regulation […][European 
Biotech Act].’ 

(51) 

the following Article 98a is inserted; 

‘Article 98a 

Development plan for the EU Portal and database 

The  Agency  shall  be  responsible  for  reporting,  on  the  development,  maintenance 
and,  where  relevant,  adjustment  of  the  EU  portal  in  terms  of  timing,  budgetary 
compliance and quality. 

This  would  include  a  submission,  after  consulting  the  Commission,  of  a  revised 
development plan for EU Portal and database to the Agency’s Management Board 1 
month after entry into force of Regulation (EU)…/… of the European Parliament and 
of the Council [include reference to Biotech Act  proposal].* The development plan 
shall  ensure  that  all  required  system  functionalities  are  available  by  the  date  of 
application as defined in Article [..] of Regulation (EU)…/…[Biotech Act proposal]. 

The  summary  of  the  development  plan  with  key  milestones  and  timelines  [once 
approved by the Management Board of the Agency] shall be made publicly available 
at the website of the Agency.’ 

*Biotechnology proposal 

(52) 

Annex I is amended in accordance with Annex I to this Regulation. 

Article 59 

Amendments to Regulation (EU) 2019/6  

Regulation (EU) 2019/6 is amended as follows: 

(1) 

in Article 3, the following paragraph 3 is inserted: 

“The  Union  GMO  legislation  shall  not  apply  to  veterinary  medicinal  products 
containing  or  consisting  of  genetically  modified  organisms  that  are  authorised  or 
manufactured in accordance with this Regulation.  The administration of veterinary 
medicinal  products  shall  not  bring  the  treated  animal  or  their  products  under  the 
scope of the GMO rules.” 

(2) 

in Article 4, the following points (45), (46) and (47) are added: 

(45)  “zoonosis’ means any disease and/or infection which is naturally transmissible 

directly or indirectly between animals and humans 

(46)  “‘veterinary  medicinal  products  containing  or  consisting  of  genetically 
modified  organisms’  means  veterinary  medicinal  products  that  contain  or 
consist  of genetically modified organisms as defined in  Article 2 point  (2) of 
Directive  2001/18/EC”  excluding  organisms  obtained  through  the  techniques 
of genetic modification listed in Annex I B to Directive 2001/18/EC”; 

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(47)  ‘‘regulatory sandbox’ means a time-limited regulatory framework that enables 
the development, placing on the market or use, under regulatory supervision, of 
innovative  technologies,  methods  or  products  related  to  animal  health  which 
are  directly  or  indirectly  related  to  the  development,  manufacturing  or  use  of 
veterinary  medicinal  products  and  which  are  not  regulated  under  Union 
legislation’; 

(3) 

(4) 

in Article 8, paragraph 5 is deleted; 

Article 9 is amended as follows: 

(a) 

the following paragraph 2a is inserted: 

‘2a.  In case of clinical trials with veterinary medicinal products containing or 
consisting  of  genetically  modified  organisms,  the  competent  authorities 
shall  assess  potential  adverse  effects  on  human  health  and  the 
environment, having regard to the specific characteristics of the product 
and in accordance with the principles for environmental risk assessment 
set  out  in  Annex  II.  Where  appropriate,  the  implementation  of  risk 
mitigation measures shall be required’. 

(b) 

in paragraph (3), the following subparagraph is added: 

‘During  this  period,  where  the  trial  concerns  a  veterinary  medicinal  product 
containing  or  consisting  of  genetically  modified  organisms,  the  competent 
authorities may consult with the bodies set up by the Union or Member States 
in accordance with under Directive 2001/18/EC, in particular in case of novel 
questions  or  fist-in-class  veterinary  medicinal  products.  The  consulted  bodies 
shall  ensure  protection  of  commercially  confidential  information  and  security 
of exchange of information.’ 

(c) 

In paragraph (4), the following subparagraph is added: 

‘In  the  context  of  the  sponsor’s  obligation  to  determine  that  there  are  no 
environmental grounds precluding the conduct of the study, in case of clinical 
trials with veterinary medicinal products containing or consisting of genetically 
modified  organisms,  where  a  risk  to  the  environment  or  human  health  is 
identified,  mitigation  measures  shall  be  implemented  before  the  start  of  the 
trial, having regard to the specific characteristics of the product, the magnitude 
of the possible hazard and likelihood of that adverse effect occurring.’  

(5) 

In Article 28, paragraph 2 is replaced by the following:  

‘During the process of examination of applications for marketing authorisations for 
veterinary  medicinal  products  containing  or  consisting  of  genetically  modified 
organisms, the Agency may hold consultations with the bodies set up by the Union or 
Member  States  in  accordance  with  Directive  2001/18/EC,  in  particular  for  first-in-
class  products  or  when  a  novel  question  arises.  The  consulted  bodies  shall  ensure 
protection  of  commercially  confidential  information  and  security  of  exchange  of 
information.’ 

(6) 

The following Article 40a is inserted: 

Extension of the supplementary protection certificate concerning biotechnology 
medicinal products treating zoonoses developed and authorised in the Union 

‘Article 40a 

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1.  Where  a  marketing  authorisation  is  granted  by  the  Union  to  a  veterinary 
medicinal product developed by means of a biotechnology process referred to 
in paragraphs 2(a) of Article 42 of Regulation (EU) 2019/6 that is intended to  
diagnose,  treat  or  prevent  zoonotic  diseases,  and  that  is  protected  either  by  a 
supplementary  protection  certificate  in  accordance  with  Regulation  (EC)  No 
469/200974  of  the  European  Parliament  and  of  the  Council  ,  or  by  a  patent 
which  qualifies  for  the  granting  of  such  supplementary  protection  certificate, 
the  holder  of  a  patent  or  of  such  certificate  shall  be  entitled  to  a  12-month 
extension  of  the  periods  referred  to  in  Article  13,  paragraphs  1  and  2  of 
Regulation  (EC)  No  469/2009,  provided  that  the  marketing  authorisation 
applicant demonstrates that all of the following conditions are met: 

(a) 

(b) 

the medicinal product contains a new active substance distinctly different 
from that of any authorised medicinal product in the Union; 

the  veterinary  medicinal  product  has  a  mechanism  of  action  distinctly 
different and shows a level of safety and efficacy which at least euivalent 
to that that of any authorised veterinary medicinal product in the Union 
for the same zoonotic disease; and 

(c) 

at  least  a  manufacturing  step,  excluding  packaging,  quality  testing  and 
certification is performed in the Union. 

2. 

The  Agency  shall  assess  compliance  with  the  conditions  referred  to  ins 
paragraph 1 as part of the marketing authorisation procedure concerned. 

3.  Where compliance is confirmed, the Agency´s opinion shall  issue a statement 

to that effect. 

4.  A  copy  of  the  statement  referred  to  in  paragraph  3  shall  be  included  in  the 
application  for  a  certificate  lodged  under  article  7  of  of  Regulation  (EC)  No 
469/2009. 

(7) 

Article 61 is replaced by the following: 

‘Article 61 

Variations that do not require assessment 

1.  Marketing  authorisation  holders  shall  be  entitled  to  implement  variations 
included  in  the  list  established  in  accordance  with  Article  60(1),  under  the 
conditions specified therein. 

2.  Where a variation referred to in paragraph (1) affects the summary of product 
characteristics,  the  labelling  or  package  leaflet,  the  marketing  authorisation 
holder shall record the change in the product database within 30 days after its 
implementation.  

The competent authority that granted the marketing authorisation or, in the case 
of  veterinary  medicinal  products  authorised  under  the  centralised  procedure, 
the  Commission  following  an  opinion  by  the  Agency,  shall  amend  the 

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Regulation  (EC)  No  469/2009  of  the  European  Parliament  and  of  the  Council  of  6  May  2009 
concerning the supplementary protection certificate for medicinal products, OJ L 152, 16.6.2009, pp. 1 

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marketing  authorisation  in  accordance  with  the  change  recorded  by  the 
marketing authorisation holder in the product database.  

For veterinary medicinal  products  authorised under the centralised procedure, 
the  amendment  of  the  marketing  authorisation  shall  be  made  by  means  of 
implementing acts which shall be adopted in accordance with the examination 
procedure referred to in Article 145(2). 

3.  Where a variation as referred to in paragraph (1) does not affect the summary 
of  product  characteristics,  labelling  or  package  leaflet,  the  marketing 
authorisation holder shall record the change in the product database within one 
year after its implementation. 

4.  Variations  implemented  by  marketing  authorisation  holders  in  circumvention 
of the conditions laid down in the implementing act referred to in Article 60(1) 
shall not be valid.’ 

(8) 

the following Chapter IX is added: 

‘CHAPTER IX  

REGULATORY SANDBOX 

Article 136a 

Regulatory sandbox 

1. 

The  Commission  may  set  up  a  regulatory  sandbox  in  accordance  with  the 
procedure set  out  in  paragraphs 2 and 4 for innovative technologies, methods 
or products related to animal health which are directly or indirectly related to 
the  development,  manufacturing  or  use  of  veterinary  medicinal  products  and 
which  are  not  regulated  under  other  Union  legislation,  where  the  following 
conditions are met: 

(a) 

(b) 

it can be expected that those technologies, methods or products will have 
a positive impact on animal health without unacceptable negative impacts 
on human health or the environment;  

the  development,  placing  on  the  market  or  use  of  the  technologies, 
methods or products  concerned is hindered by the lack of a harmonised 
legal framework. 

2.  Developers  of  technologies,  methods  or  products  related  to  animal  health 
which  are  directly  or  indirectly  related  to  the  development,  manufacturing  or 
use of veterinary medicinal products  and which  are not  regulated under  other 
Union  legislation  may  send  an  application  to  the  Agency  requesting  the 
development  of  a  regulatory  sandbox.    The  Agency  shall  assess  applications 
received  and,  based  on  its  assessment,  may  submit  a  recommendation  to  the 
Commission which shall include all of the following: 

(a) 

a justification for the regulatory sandbox, including  a description of the 
proposed technologies, methods or products to be included; 

(b) 

identification of existing regulatory challenges; 

(c) 

estimation  of  potential  benefits  and  potential  risks  to  animal  or  human 
health or the environment; 

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(d)  mapping of existing expertise available to the Agency required to address 
potential  benefits  and  risks  referred  to  in  point  (c).    Where  no  relevant 
expertise is readily available to the Agency, it shall present a plan on how 
it intends to address the points identified under point (c); 

(e) 

a proposal for the duration of the regulatory sandbox. 

3.  Upon  receipt  of  the  Agency’s  recommendation,  the  Commission  shall  take  a 
decision, by means of an implementing act, in accordance with the examination 
procedure  referred  to  in  Article  145(2).  Where  the  Commission  agrees  to  the 
establishment of a regulatory sandbox, the implementing  act  shall specify the 
duration of the regulatory sandbox.  

4.  After a regulatory sandbox is established, the Agency shall take the following 

measures: 

(a) 

develop  and  make  publicly  available 
technical  and  scientific 
requirements for technologies, methods or products developed under the 
regulatory  sandbox,  taking  due  account  of  the  potential  risks  of  thereof 
for human and animal health and the environment;  

(b)  develop  rules  of  procedure  which  ensure  that  the  confidentiality  of 

(c) 

(d) 

information exchanged is maintained; 

provide relevant scientific advice; 

assess  the  benefits  and  risks  of  technologies,  methods  or  products 
developed under the regulatory sandbox and, where it considers that the 
benefits  outweigh  the  risks,  it  shall  address  to  the  Commission  a 
recommendation for their placing on the market or use.  

The Agency shall levy a fee from the applicants in accordance with Article 4 of 
Regulation (EU) 2024/56875 for the activities referred to in points c) and d) of 
the  first  subparagraph.    The  applicable  amounts  shall  be  published  on  the 
website of the Agency. 

5. 

The Commission may, by means of an implementing act, authorise the placing 
on  the  market  or  the  use  of  the  technologies,  methods  or  products  developed 
under  a  regulatory  sandbox  in  accordance  with  the  examination  procedure 
referred to in Article 145(2). 

Technologies, methods or products developed under a regulatory sandbox shall 
not  be  placed  on  the  market  or  used  until  they  have  been  authorised  by  the 
Commission.  

6.  Where  a  serious  risk  to  public  or  animal  health  or  to  the  environment 

associated with the use of technologies, methods or products developed under   
a regulatory sandbox is identified by national competent authorities, they shall 
swiftly  inform  the  Agency.    Pending  the  adoption  of  a  Commission  decision 
pursuant  to  paragraph  8,  national  competent  authorities  may  take  interim 

75 

Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees 
and  charges  payable  to  the  European  Medicines  Agency,  amending  Regulations  (EU) 2017/745  and 
(EU) 2022/123  of  the  European  Parliament  and  of  the  Council  and  repealing  Regulation  (EU) 
No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 
(OJ L OJ L 568, 14.2.2024) 

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measures,  including  the  suspension  of  their  placing  on  the  market,  the 
suspension of use, or recall measures. 

7.  Where the Agency is notified of a serious risk in accordance with paragraph 6, 
it shall swiftly assess the referred matter and, where appropriate, any possible 
impact  for  similar  technologies,  methods  or  products  placed  on  the  market 
which  have  been  developed  or  used  under  a  regulatory  sandbox.    In  its 
assessment,  the  Agency  shall  consider  the  benefits  for  animal  health  and  the 
identified risks. 

8.  Where the assessment referred to in paragraph 7 concludes that the benefit-risk 
balance is negative and there are no satisfactory risk mitigation measures that 
can  be  implemented,  the  Agency  shall  recommend  the  suspension  or 
withdrawal of authorisation for placing on the market or use. The Commission 
shall take a decision, by means of an implementing act, in accordance with the 
examination procedure referred to in Article 145(2). 

9. 

Following  the  assessment  referred  to  in  paragraphs  7,  the  Agency  may 
recommend  the  Commission  to  put  an  end  to  the  regulatory  sandbox.  The 
Agency’s  recommendation  shall  advise  on  appropriate  actions  concerning  the 
technologies,  methods  or  products  in  development  under  the  regulatory 
sandbox. The Commission may, by means of an implementing act, terminate a 
regulatory sandbox in accordance with the examination procedure referred to in 
Article 145(2).  

10.  Two years before the end of the period of validity of an established regulatory 
sandbox, the Agency shall submit an assessment report on the progress of the 
regulatory  sandbox  to  the  Commission,  including  recommendations  for  a 
regulatory  framework  after  the  end  of  the  regulatory  sandbox.  Where 
appropriate, it may recommend the extension of the duration of the regulatory 
sandbox.  

11.  The Commission shall review the assessment report referred to in paragraph 10 
and may take appropriate actions as regards the regulatory requirements for the 
marketing or use of technologies, methods or products under the scope of the 
regulatory  sandbox  after  the  termination  thereof.  Where  appropriate,  the 
Commission may extend the duration of a regulatory sandbox, by means of an 
implementing act, in accordance with the examination procedure referred to in 
Article 145(2).  

12.  The  Agency  shall  keep  a  registry  of  regulatory  sandboxes  established  in 
accordance with this Regulation. It shall prepare and publish each year a report 
on the implementation of the regulatory sandbox.’  

(9) 

Article 146 is replaced by the following: 

‘Article 146 

Amendments to Annex II 

‘The Commission is empowered to adopt delegated acts in  accordance with Article 
147(2)  in  order  to  amend  Annex  II  to  take  due  account  of  technical  and  scientific 
progress.’ 

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(10) 

Annex II to Regulation (EU) 2019/6 is amended in accordance with Annex III to this 
Regulation. 

Article 60 

Amendments to Regulation (EU) 2024/795  

Regulation (EU) 2024/795 is amended as follows: 

(a) 

in Article 2, the following paragraph 9 is added: 

‘9.  Health  biotechnology  strategic  projects, 

including  high-impact  health 
biotechnology strategic projects recognised in accordance with Regulation […]  
[European Biotech Act ] shall be deemed to contribute to the STEP objectives 
referred to in paragraph 1, point (a)(iii) or point (b), as appropriate.  

(b) 

in Article 4, paragraph 7 is replaced by the following: 

‘7.  Strategic projects recognised in accordance with the relevant provisions of the 
Regulation  (EU)  2024/1735,  Regulation  (EU)  2024/1252,  Regulation  […] 
[Critical Medicines Act] and health biotechnology strategic projects, including 
high-impact  health  biotechnology  strategic  projects  recognised  in  accordance 
with  Regulation  […]    [European  Biotech  Act]  that  fall  within  the  scope  of 
Article  2  of  this    Regulation  and  that  receive  a  contribution  under  the 
programmes  referred  to  in  Article  3  of  this  Regulation  may  also  receive  a 
contribution  from  any  other  Union  programme,  including  funds  under  shared 
management,  provided  that  those  contributions  do  not  cover  the  same  costs. 
The  rules  of  the  relevant  Union  programme  shall  apply  to  the  corresponding 
contribution  to  the strategic project.  The cumulative funding shall not  exceed 
the  total  eligible  costs  of  the  strategic  project.  The  support  from  the  different 
Union  programmes  may  be  calculated  on  a  pro  rata  basis  in  accordance  with 
the documents setting out the conditions for support.’; 

(c) 

in Article 6(1), point (c) is replaced by the following: 

‘(c)  details  of  projects  that  have  been  recognized  as  strategic  projects  under 
Regulation  (EU) 2024/1735, Regulation  (EU) 2024/1252  and Regulation  […] 
[Critical  Medicines  Act]  and  as  health  biotechnology  strategic  projects, 
including  as  high-impact  health  biotechnology  strategic  projects  under 
Regulation […] [European Biotech Act], to the extent that they fall within the 
scope of Article 2 of this Regulation.’. 

Article 61 

Amendment to Regulation (EU) 2024/1938 

Regulation (EU) 2024/1938 is amended as follows:  

(1) 

In Article 3, the following point (60) is added: 

‘(60)  ‘regulatory sandbox’ means a regulatory  framework which allows to develop, 
assess  and  test  innovative  or  adapted  regulatory  solutions  within  a  controlled 
environment pursuant to a specific plan, for a limited time and under regulatory 
supervision and which facilitates the development, assessment, authorisation or 
monitoring of innovative activities or substances which are likely to fall within 
the scope of this Regulation.’ 

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(2) 

in Article 13, the following paragraph 3a is inserted: 

‘3a.  The Commission may adopt implementing acts, setting out time limits for  the 
provision, by the competent authorities consulted in accordance with paragraph 
2, of a reply on the regulatory status of a substance, product or activity. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2).’ 

(3) 

in Article 69(2), the first subparagraph is replaced by the following: 

‘The Commission may adopt implementing acts setting out time limits for the SCB, 
to  issue  its  opinions  on  the  regulatory  status  of  a  substance,  product  or  activity,  in 
accordance with Article 13(3), first subparagraph.  

The Commission may adopt implementing acts setting out criteria and procedures for 
the consultation of advisory bodies established under other relevant Union legislation 
in  relation  to  the  performance  of  the  SCB  tasks,  including  time  limits  for  those 
bodies to issue their opinions in the framework of such consultation.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2) 

(4) 

the following Article 39a is inserted: 

Article 39a 

SoHO regulatory sandboxes  

1.  On  a  substantiated  request  from  a  SoHO  entity,  a  Member  State  may  set  up 
regulatory  sandboxes  that  provide  a  time  limited  controlled  environment  to 
facilitate  the  development  and  testing  of  innovative  products,  services, 
processes or substances in the field of SoHO, under the supervision of one or 
more competent authorities and where the following conditions are met: 

(a) 

(b) 

the characteristics or methods of those innovations and technologies are 
expected  to  distinctively  contribute  to  the  safety,  quality,  including  the 
effectiveness  of  the  SoHO  or  the  SoHO  activity  or  to  provide  a  major 
contribution to patient access to treatment;   

the  application  of  the  requirements  of  this  Regulation  would  impede  or 
significantly  delay 
innovations  and 
technologies,  due  to  scientific  or  regulatory  challenges  arising  from  the 
characteristics or methods related to that innovation or technology. 

the  development  of 

those 

2.  Member  States  may  jointly  set  up  the  regulatory  sandboxes  referred  to  in 
paragraph  1.  The  Commission  shall  support  such  cooperation  in  accordance 
with Article 72 (1).  

3. 

4. 

The regulatory sandbox  shall seek to  allow the assessment of the innovations 
referred to  in  paragraph  1 in  a real-world  environment under strict regulatory 
supervision,  to  ensure  that  the  necessary  evidence  and  data  is  generated  to 
demonstrate  their  safety  quality,  including  effectiveness  in  view  of  their 
distribution. 

The  regulatory  sandbox  may  include  clearly  described  derogations  from  the 
requirements set out in this Regulation. Those derogations may entail adapted, 
enhanced, waived or deferred requirements. Each derogation shall be limited to 

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5. 

6. 

what is apt and strictly necessary to attain the objectives pursued and shall be 
duly justified and specified in the sandbox plan referred to in paragraph [6].  

However,  the  regulatory  sandbox  shall  not  include  derogations  from  the 
provisions  on  standards  concerning  voluntary  and  unpaid  nature  of  SoHO 
donations laid down in Article 54.  

The  regulatory  sandboxes  shall  be  conducted  under  the  supervision  of  the 
SoHO  competent  authorities,  and,  where  appropriate,  in  cooperation  with 
competent  authorities  acting  in  accordance  with  other  relevant  Union 
legislative acts in the area of health or national legislation.  

The activities within the regulatory sandbox shall take place in accordance with 
a  specific  regulatory  sandbox  plan  developed  by  the  SoHO  competent 
authorities. The sandbox plan shall: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

be informed by data provided by, and established following consultations 
with, the developers of the concerned innovations; 

identify  the  participants  in  the  regulatory  sandbox  and  their  respective 
roles; 

identify  the  requirements  of  this  Regulation  that  cannot  be  complied 
with, from which derogations are considered necessary and the adapted, 
enhanced, waived or deferred requirements entailed by such derogations; 

include appropriate measures to mitigate potential risks to health and to 
the environment; 

establish the duration of the regulatory sandbox. 

explain the monitoring framework for the regulatory sandboxes including 
what  aspects  will  be  reported  on,  the  frequency  of  reporting  and  data 
sources. 

7.  When  establishing  the  regulatory  sandbox,  the  SoHO  competent  authorities 
shall  consult,  where  appropriate,  the  SCB,  including  by  requesting  scientific, 
technical  or  regulatory  advice  for  the  design  of  the  sandbox  plan.  The  SCB 
shall  provide  support  and  shall  seek  to  foster  a  common  approach  for  the 
design  and the implementation  of the regulatory sandboxes referred to  in this 
Article.  

For  the  purposes  of  the  support  to  SoHO  competent  authorities  referred  to  in 
the first subparagraph, the SCB may: 

(a) 

leveraging 

request  information  and  data  from  holders  of  authorisations  of  SoHO 
preparations, 
the  EU  SoHO  platform 
information  on 
established  under  article  74  of  this  Regulation,  developers,  independent 
experts  and  researchers,  representatives  of  healthcare  professionals  and 
patients and may engage with them in preliminary discussions; 

(b) 

collaborate  with  the  Foresight  Panel  for  Emerging  Health  Innovation 
referred to in article 38 of Regulation (EU) …/…[European Biotech Act]. 

8.  When setting up the regulatory sandbox, the SOHO competent authorities shall 
provide  detailed,  non-confidential  information  to  the  Commission,  regarding 
the regulatory framework governing the specific regulatory sandbox set out in 
a  regulatory  sandbox  plan.  The  Commission  shall  publish  the  information 

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received,  on  theEU  SoHO  platform  established  under  article  74  of  this 
Regulation. 

9.  Upon the termination of the regulatory sandbox, the competent authorities shall 
submit to the SCB and to the Commission a detailed report on the regulatory 
sandbox  and  any  possible  follow  up  concerning  in  particular  changes  in  the 
regulatory  framework  for  the  innovations  or  categories  of  innovations 
concerned, based on the learnings from the regulatory sandbox. The SCB shall 
publish the information received. 

The information referred to in the first subparagraph may also be provided at 
regular intervals during the implementation of the sandbox.  

10.  A  SoHO  preparation  resulting  from  an  innovation  developed  as  part  of  a 
regulatory  sandbox  may  be  distributed  for  human  application  only  where 
authorised  in  accordance  with  Article  38(1).  The  initial  validity  of  such 
authorisation  shall  not  exceed  the  duration  of  the  regulatory  sandbox.  The 
authorisation may be extended by the competent authority at the request of the 
relevant SoHO entity. 

11.  The  regulatory  sandboxes  shall  not  affect  the  enforcement  and  monitoring 
responsibilities of the SoHO competent authorities pursuant to this Regulation 
and to other Union legislation.  

12.  Participants in the regulatory sandbox, in particular the developer shall remain 
liable  under  applicable  national  legislation  for  any  harm  inflicted  on  third 
parties as a result from the testing taking place in the regulatory sandbox. They 
shall inform  the national  SoHO  competent  authorities without undue delay of 
any information which might entail the amendment of the regulatory sandbox 
or  concerns  the  quality,  safety  or  efficacy  of  products  developed  as  part  of  a 
regulatory sandbox. 

13. 

In  case  of  identification  of  risks  to  public  health  or  safety  concerns  or  the 
environment associated with the use of the innovation covered by a regulatory 
sandbox,  the  sandbox  participants  shall  immediately  inform  the  SoHO 
competent  authorities  of  the  action  taken  to  prevent  those  risks.  The  SoHO 
competent authorities shall take immediate and adequate temporary corrective 
measures,  including  to  suspend,  revoke  or  restrict  the  scope  of  the  regulatory 
sandbox and shall inform the SCB and the Commission thereof. 

CHAPTER [X] 

FINAL PROVISIONS 

Article 62 

Monitoring 

The  Commission  shall  publish  and  keep  up  to  date  a  list  of  health  biotechnology  strategic 
projects and high impact health biotechnology strategic projects. 

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1. 

2. 

1. 

2. 

3. 

4. 

5. 

6. 

Article 63 

Evaluation 

No sooner than [insert date, five years after the date of entry into application of this 
Regulation...], the Commission shall evaluate this Regulation in light of the general 
objective  that  it  pursues  and  referred  to  in  Article  1(1)]and  present  a  report  on  its 
main  findings  to  the  European  Parliament  and  to  the  Council,  the  European 
Economic and Social Committee, and the Committee of the Regions, in particular on 
the impact of this Regulation and progress towards that objective.  

The Member States shall,  upon request,  provide  the Commission  with  any relevant 
information they have and that the Commission may need for its assessment pursuant 
to in paragraph 1. 

Article 64 

Exercise of the delegation 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The power to adopt delegated acts referred to in Article 43(2) shall be conferred on 
the Commission for a period of five years from [insert date of entry into force of this 
Regulation]. The Commission shall draw up a report in respect of the delegation of 
power  not  later  than  nine  months  before  the  end  of  the  five-year  period.  The 
delegation  of  power  shall  be  tacitly  extended  for  periods  of  an  identical  duration, 
unless the European Parliament or the Council opposes such extension not later than 
three months before the end of each period. 

The delegation of power referred to in Articles 43(2) may be revoked at any time by 
the European Parliament or by the Council. A decision to revoke shall put an end to 
the  delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day 
following  the  publication  of  the  decision  in  the  Official  Journal  of  the  European 
Union  or  at  a  later  date  specified  therein.  It  shall  not  affect  the  validity  of  any 
delegated acts already in force. 

Before adopting a delegated act, the Commission shall consult experts designated by 
each  Member  State 
the 
in  accordance  with 
Interinstitutional Agreement on Better Law-Making of 13 April 2016. 

the  principles 

laid  down 

in 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

A delegated act adopted pursuant to Articles 43(2), shall enter into force only if no 
objection  has  been  expressed  either  by  the  European  Parliament  or  by  the  Council 
within a period of two months of notification of that act to the European Parliament 
and the Council or if, before the expiry of that period, the European Parliament and 
the  Council  have  both  informed  the  Commission  that  they  will  not  object.  That 
period shall be extended by two months at the initiative of the European Parliament 
or of the Council. 

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1. 

2. 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

Article 65 

Committee procedure 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  Biotechnology. 
That  committee  shall  be  a  committee  within  the  meaning  of  Regulation  (EU)  No 
182/2011.  

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply.  

Article 66 

Handling of confidential information 

Information  acquired  in  the  course  of  implementing  this  Regulation  shall  be  used 
only for the purposes of this Regulation and shall be protected by the relevant Union 
and national law. 

Member States and the Commission shall ensure the protection of trade and business 
secrets  and  other  sensitive,  confidential  and  classified  information  obtained  and 
processed  in  application  of  this  Regulation,  including  recommendations  and 
measures to be taken, in accordance with Union and relevant national law. 

The  Commission  and  Member  States  shall  ensure  that  classified  information 
provided or exchanged pursuant to this Regulation is not downgraded or declassified 
without the prior written consent of the originator in accordance with relevant Union 
or national law. 

The  Commission  and  the  national  authorities,  their  officials,  employees  and  other 
persons  working  under  the  supervision  of  those  authorities  shall  ensure  the 
confidentiality  of  information  obtained  in  carrying  out  their  tasks  and  activities  in 
accordance  with  relevant  Union  or  national  law.  This  obligation  also  applies  to  all 
representatives of Member States, observers, experts and other participants attending 
meetings of the Steering Group. 

Article 67 

Entry into force and application 

This  Regulation  shall  enter  into  force  on  the  twentieth  day  following  that  of  its 
publication in the Official Journal of the European Union. 

It shall apply as of the day of entry into force.  

By way of derogation from paragraph 2: 

(a)  Article  58,  points  (5)  to  (12)  and  points  (15)  to  (24)  shall  apply  as  of  [OP, 

please insert date: six months after entry into force of this Regulation]; 

(b)  Article  58,  point  (13)  shall  apply  as  of  [OP,  please  insert  date:  nine  months 

after entry into force of this Regulation]; 

(c)  Article  58,  point  (25)  shall  apply  as  of  [OP,  please  insert  date:  nine  months 

after entry into force of this Regulation]. 

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This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Strasbourg, 

For the European Parliament 
The President 

For the Council 
The President 

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LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT- AGENCIES 

TABLE OF CONTENTS 

LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT ................................................ 1 

1. 

1.1. 

1.2. 

1.3. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  ................................................ 3 

Title of the proposal/initiative ...................................................................................... 3 

Policy area(s) concerned  ............................................................................................. 3 

Objective(s) .................................................................................................................. 3 

1.3.1.  General objective(s) ..................................................................................................... 3 

1.3.2.  Specific objective(s) ..................................................................................................... 3 

1.3.3.  Expected result(s) and impact ...................................................................................... 4 

1.3.4. 

Indicators of performance ............................................................................................ 4 

1.4. 

1.5. 

The proposal/initiative relates to:  ................................................................................ 4 

Grounds for the proposal/initiative  ............................................................................. 5 

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative ............................................................ 5 

1.5.2.  Added value of EU involvement (it may result from different factors, e.g. 

coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this section 'added value of EU involvement' is the value resulting 
from EU action, that is additional to the value that would have been otherwise 
created by Member States alone. ................................................................................. 5 

1.5.3.  Lessons learned from similar experiences in the past .................................................. 6 

1.5.4.  Compatibility with the multiannual financial framework and possible synergies with 

other appropriate instruments ....................................................................................... 6 

1.5.5.  Assessment of the different available financing options, including scope for 

redeployment ................................................................................................................ 7 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.2.1. 

2.2.2. 

Duration of the proposal/initiative and of its financial impact .................................... 8 

Method(s) of budget implementation planned  ............................................................ 8 

MANAGEMENT MEASURES ................................................................................ 10 

Monitoring and reporting rules  ................................................................................. 10 

Management and control system(s)  .......................................................................... 10 

Justification of the budget implementation method(s), the funding implementation 
mechanism(s), the payment modalities and the control strategy proposed ................ 10 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them.......................................................................................................... 11 

2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio between 

the control costs  and the value of the related funds managed), and assessment of the 
expected levels of risk of error (at payment & at closure)  ........................................ 12 

2.3. 

Measures to prevent fraud and irregularities  ............................................................. 12 

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3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  ........... 14 

Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected  ...................................................................................................................... 14 

3.2. 

Estimated financial impact of the proposal on appropriations  .................................. 15 

3.2.1.  Summary of estimated impact on operational appropriations ................................... 15 

3.2.1.1.  Appropriations from voted budget ............................................................................. 15 

3.2.3.  Summary of estimated impact on administrative appropriations  .............................. 20 

3.2.3.1. Appropriations from voted budget .............................................................................. 20 

3.2.4.  Estimated requirements of human resources ............................................................. 20 

3.2.4.1.  Financed from voted budget....................................................................................... 21 

3.2.5.  Overview of estimated impact on digital technology-related investments ................ 24 

3.2.6.  Compatibility with the current multiannual financial framework ............................. 25 

3.2.7.  Third-party contributions  .......................................................................................... 25 

3.2.8.  Estimated human resources and the use of appropriations required in a decentralised 

agency  ....................................................................................................................... 26 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

Digital dimensions ..................................................................................................... 35 

Requirements of digital relevance .............................................................................. 35 

Data ............................................................................................................................ 71 

Digital solutions ......................................................................................................... 78 

Interoperability assessment ........................................................................................ 79 

Measures to support digital implementation .............................................................. 83 

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1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

Proposal  for  a  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF 
THE  COUNCIL  on  establishing  a  framework  of  measures  for  strengthening 
Europe’s  biotechnology  and  biomanufacturing  sectors  and  amending  Regulations 
(EU) No 536/2014 (‘Clinical Trials Regulation’), (EC) No 1394/2007 (ATMP), (EU) 
2024/1938  (SoHO),  (EU)  2019/6  (Veterinary  Medicine  Products  Regulation),  and 
Regulation (EC) No 178/2002 (General Food Law) ('EU Biotech Act') 

1.2. 

Policy area(s) concerned  

Priority Area: Competitiveness, prosperity and security 

Health, Biotech, Agriculture and Bioeconomy 

1.3. 

Objective(s) 

1.3.1.  General objective(s) 

 (i) to improve the functioning of the internal market by establishing a framework to 
strengthen the competitiveness  of the health biotechnology  sector, from  research to 
production,  

(ii)  to  create  the  conditions  for  the  development  and  timely  placing  on  the  Union 
market, of biotechnology innovations, products and services,  

(iii)  while  safeguarding  high  standards  for  the  protection  of  human  health,  animal 
health,  patients  and  consumers,  the  environment,  ethics,  quality,  food  and  feed 
safety, and biosecurity. 

1.3.2. 

Specific objective(s) 

This general objective translates into the following specific objectives: 

strengthen  the  biotechnology  sector  and  reinforce  the  Union’s  research, 
(i) 
development  and  production  capabilities,  by  establishing  a  framework  for  the 
recognition of, and support measures for, strategic health biotechnology projects and 
high impact strategic health biotechnology projects (pillar 1); 

(ii) 
support  funding  of,  investments  in,  and  access  to  capital  for,  biotechnology 
companies  and  projects,  including  through  the  setting  up  of  an  EU  health 
biotechnology  investment  pilot  to  fill  the  gap  in  spending  on  biotechnology 
innovation (pillar 2); 

improve  the  EU  manufacturing  capacity  of,  and  expertise  in  biosimilars, 

(iii) 
including through international cooperation (pillar 3); 

(iv) 
facilitate  the  application  of  AI  into  the  Union’s  biotechnology  and  health 
technology  manufacturing  ecosystems  and  frameworks,  in  line  with  the  Regulation 
(EU) 2024/1689 (pillar 4); 

ensure a legislative framework that encourages innovation and takes account of 
(v) 
technological  and  scientific  developments  and  progress,  by  establishing  provisions 
for health biotechnology products (pillar 5);  

(vi)  prevent  the  misuse  of  biotechnologies  and  strengthen  biodefence  capabilities 
(pillar 6). 

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(vii)  enable  the  effectiveness  of  the  measures  under  the  pillars  1  to  6  through  a 
legislative  framework  conducive  to  the  use  of  biotechnology  innovations,  by 
amending  Union  legislation  in  particular  on  clinical  trials,  veterinary  medicinal 
products, food and feed safety and related legislation (pillar 7).  

1.3.3.  Expected result(s) and impact 

Specify 
the  effects  which 
beneficiaries/groups targeted. 

the  proposal/initiative 

should  have  on 

the 

Overall,  the  Biotech  Act  is  expected  to  support  a  smooth  function  of  the  Union 
internal  market  and  the  resilience  and  competitiveness  of  the  Union  biotechnology 
and biomanufacturing sector, while allowing allow end-users - including patients - to 
benefit from the availability of innovative technologies in the EU. 

The Biotech Act will have the following expected results: 

– 

– 

– 

– 

– 

– 

-  regulatory  procedures  to  place  products  on  the  market  are  predictable, 
simplified and shorter, with reduced administrative burden; 

-  innovation  is  supported  by  specific  regulatory  procedures  that  are  fit  for 
technological and scientific progress; 

- operators have better access to funding throughout the different stages of their 
development; 

- the EU’s capabilities in research, development and production are reinforced, 
including for biodefence 

- availability of a skilled biotechnology workforce in the Union is improved; 

- there are clear rules preventing the misuse of biotechnologies. 

1.3.4. 

Indicators of performance 

Specify the indicators for monitoring progress and achievements. 

Progress towards the objectives of the Biotech Act will be monitored using a set of 
quantitative  and  qualitative  indicators.  This  assessment  will  draw  on  the  strategic 
mapping of the Union’s biotechnology ecosystem, to be established and maintained 
by the Commission. 

Such monitoring shall be based on key performance indicators such as the increase in 
the  number  of  clinical  trials  in  the  Union  over  the  period  of  five  years,  as  this 
indicator  reflects  both  the  attractiveness  of  the  Union  and  the  capacity  of  the 
European  regulatory  system  to  support  clinical  research  with  maintained  high  data 
quality and patients’ safety standards.  

1.4. 

The proposal/initiative relates to:  

 a new action  
¨ a new action following a pilot project / preparatory action1  

1 

As referred to in Article 58(2), point (a) or (b) of the Financial Regulation. 

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 the extension of an existing action  

¨ a merger or redirection of one or more actions towards another/a new action 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative 

In  the  short  term,  the  initiative  requires  the  Commission  to  complete  the  strategic 
mapping  of  the  Union’s  biotechnology  ecosystem  within  six  months  of  entry  into 
force and to initiate the establishment of the new governance and support structures 
foreseen  in  the  Regulation,  including  the  EU  Health  Biotechnology  Support 
Network,  the  Emerging  Innovation  Foresight  Panel  and  the  European  Health 
Biotechnology Steering Group. The Commission would also proceed with adopting 
the necessary implementing and delegated acts, including those detailing the criteria 
and  procedures  for  the  recognition  of  health  biotechnology  strategic  projects  and 
high-impact health biotechnology strategic projects. In parallel, Member States must 
designate  national  single  points  of  contact  and  begin  applying  the  streamlined 
regulatory procedures.  

The Commission and the Agencies will have to update and/or develop new tools and 
ways  of  operation  to  implement  workflows  resulting  from  the  amendments  to  EU 
legislative  frameworks  in  the  health  and  food  area.  These  amendments  aim  at 
simplifying regulatory procedures and creating regulatory environments conducive to 
innovation.  

In the medium term, the strategic mapping would be updated and used to guide the 
selection  of  projects  and  the  deployment  of  Union  support,  as  well  as  further 
developments in Union policy for biotechnology.  

1.5.2.  Added  value  of  EU  involvement  (it  may  result  from  different  factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the  purposes  of  this  section  'added  value  of  EU  involvement'  is  the  value  resulting 
from  EU  action,  that  is  additional  to  the  value  that  would  have  been  otherwise 
created by Member States alone. 

Reasons for action at EU level (ex-ante)  

European  companies  are  not  competitive  enough  and  face  several  market  and 
regulatory  barriers.  Whilst  several  Member  States  have  taken  action  to  boost 
innovation in this field, many bottlenecks persist, and improvements are not expected 
to achieve the necessary levels for the Union to compete at a global scale. 

Important  regulatory  barriers  identified  stem  from  EU  legislation,  therefore  the 
proposed  amendments  seek  to  simplify  EU  legislations,  enhance  their  legal  clarity 
and certainty and make them fit to scientific and technological development.   

Furthermore,  the  market  drivers  are  occurring  across  the  EU,  affecting  the 
functioning of the Union single market and EU’s businesses competitiveness in the 
Union and globally. These hurdles result from insufficient capacity of EU companies 
to  access  private  finance  at  a  competitive  scale,  especially  at  later  stages  of 
development. Biotechnology clusters in the EU are scattered across Member States, 
without  cross-border  connections  and  continental  scale,  thus  not  able  to  compete 
globally.  Compounded by the low level of storage, access and sharing of data in the 
area of biotechnology - including cross-borders -, the development and deployment 

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of AI solutions for biotechnology in the  Union are not reaching their full potential. 
Finally, the gap in developing and retaining an adequately skilled workforce has been 
observed  across  the  Union.  These  challenges  are  systemic,  transnational  in  nature 
and cannot be addressed effectively through isolated national measures alone.  

Expected generated  EU added value (ex-post)  

A  harmonised  but  simplified  EU  regulatory  framework,  supported  by  strengthened 
collaboration  in  selected  policy  areas  (access  to  capital,  skills,  AI  and  data)  is 
expected to ensure all patients, users and citizens can benefit from these innovations 
to  same  extent  in  the  EU,  a  level  playing  field  for  operations  in  the  Union  single 
market as well as to enhance the overall competitiveness of the EU. Coordinated EU 
action will generate economies of scale, reduce duplication of efforts, increase legal 
certainty  for  entrepreneurs  operating  across  borders,  and  unlock  cross-border 
investments, infrastructures and skills development that Member States acting alone 
could  not  achieve.  It  will  also  reinforce  the  EU’s  strategic  autonomy  in  a  critical 
technological area foster the development of adequate biosecurity capabilities. 

1.5.3.  Lessons learned from similar experiences in the past 

Developments in the biotechnology sector over the last decades shows that Europe’s 
strong scientific base does not automatically translate into industrial competitiveness. 
Fragmented  and  complex  regulatory  frameworks,  slow  and  divergent  procedures, 
limited  access  to  risk-tolerant  capital,  insufficient  data  sharing  and  interoperability, 
shallow  public  equity  markets,  and  persistent  skills  shortages  have  repeatedly 
hindered the ability of EU innovators to scale and commercialise their technologies. 
Past  efforts  have  also  demonstrated  that  lack  of  coordinated  EU  action  leads  to 
duplication,  delays,  and  missed  opportunities  for  deploying  biotechnology  at  scale, 
while emerging technologies such as AI raise regulatory and biosecurity challenges 
that cannot be adequately addressed at national level.  

Experience from other strategic sectors saw targeted EU-level initiatives, combining 
regulatory simplification, coordinated investment,  and infrastructure support, being 
deployed  to  address  systemic  bottlenecks  -  such  as  in  the  case  of  the  Net-Zero 
Industry  Act  and  the  Critical  Raw  Materials  Act.  The  same  lessons  apply  to 
biotechnology: only a coherent and integrated EU approach can unlock the sector’s 
full  potential,  strengthen  competitiveness,  and  accelerate  the  safe  deployment  of 
biotechnology innovative across the Single Market. 

1.5.4.  Compatibility with the multiannual financial framework and possible synergies with 

other appropriate instruments 

In order to maximise its positive impact, the Biotech Act will build upon the strong 
knowledge base The objectives of the Biotech Act may be supported under the future 
European Competitiveness Fund, in particular under the Health, Biotech, Agriculture 
and  Bioeconomy  Window.  Horizon  Europe  may  also  be  leveraged  to  complement 
the  Biotech  Act’s  objective  of  bringing  biotechnology  products  to  the  market  by 
supporting all stages of research and development of innovative ideas. 

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1.5.5.  Assessment  of  the  different  available  financing  options,  including  scope  for 

redeployment 

N/A 

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1.6. 

Duration of the proposal/initiative and of its financial impact 

¨ limited duration  

–  ¨ 

in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  ¨ 

financial  impact  from  YYYY  to  YYYY  for  commitment  appropriations  and 

from YYYY to YYYY for payment appropriations.  

 unlimited duration 

–  Implementation with a start-up period from 2028 to 2029, 

–  followed by full-scale operation. 

1.7.  Method(s) of budget implementation planned2  

 Direct management by the Commission 

–   by its departments, including by its staff in the Union delegations;  

–   by the executive agencies  

–  ¨ Shared management with the Member States  

x Indirect management by entrusting budget implementation tasks to: 

–  ¨ third countries or the bodies they have designated 

–  ¨ international organisations and their agencies (to be specified) 

–   the European Investment Bank and the European Investment Fund 

–  ¨ bodies referred to in Articles 70 and 71 of the Financial Regulation 

–  ¨ public law bodies 

–   bodies governed by private law with a public service mission to the extent that 

they are provided with adequate financial guarantees 

–   bodies governed by the private law of a Member State that are entrusted with 
the  implementation  of  a  public-private  partnership  and  that  are  provided  with 
adequate financial guarantees 

–  ¨  bodies  or  persons  entrusted  with  the  implementation  of  specific  actions  in  the 
common  foreign  and  security  policy  pursuant  to  Title  V  of  the  Treaty  on 
European Union, and identified in the relevant basic act 

–    bodies  established  in  a  Member  State,  governed  by  the  private  law  of  a 
Member  State  or  Union  law  and  eligible  to  be  entrusted,  in  accordance  with 
sector-specific  rules,  with  the  implementation  of  Union  funds  or  budgetary 
guarantees,  to  the extent that such bodies are controlled by public law bodies or 
by bodies governed by private law with a public service mission, and are provided 
with  adequate  financial  guarantees  in  the  form  of  joint  and  several  Soho  by  the 
controlling bodies or equivalent financial guarantees and which may be, for each 
action, limited to the maximum amount of the Union support. 

Comments: 

2 

Details of budget implementation methods and references to the Financial Regulation may be found on 
https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-
site: 
the 
implementation/Pages/implementation-methods.aspx. 

BUDGpedia 

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The proposal envisions two main vehicles for biotechnology investment in the EU: 

Support to High Impact Health Biotechnology Strategic Projects 

High Impact  Health Biotechnology  Strategic projects  will boost the European ecosystem  by 
expanding  shared  pilot  facilities  open  to  SMEs  and  academia  alike,  financially  supporting 
Member State innovation procurement to create predictable demand for innovative products,  
and harnessing the potential of data and AI for Biotechnology  

A Biotechnology Investment Pilot 

The  Pilot    aims  to  provide  a  full  lifecycle  approach  to  biotechnology  finance  by  supporting 
both the intermediate equity approach for biotechnology equity investments and venture loans 
into the sector. This would enable European innovators to move from discovery to industrial 
scale  by  bridging  the  most  capital-intensive  stages  of  development.  A  company  may,  for 
instance, start with early-stage backing from a VC fund, then access tailored venture loans to 
build  production  capacity,  securing  co-investment  along  the  financing  journey.  By  linking 
these steps, the Pilot ensures that Europe’s biotechnology champions can grow, manufacture 
and stay anchored in Europe. 

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2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

The  proposal  relies  on  existing  legislations  and  initiatives  in  the  European 
Commission and the European Medicines Agency, which will facilitate monitoring of 
several indicators. For these, continuous data/information will be available. 

In  addition,  five  years  after  the  Regulation’s  entry  into  application,  and  every  five 
years  thereafter,  the  Commission  will  evaluate  its  implementation,  effectiveness  and 
impact. 

2.2.  Management and control system(s)  

2.2.1. 

Justification  of  the  budget  implementation  method(s),  the  funding  implementation 
mechanism(s), the payment modalities and the control strategy proposed 

The  actions  for  establishing  a  framework  of  measures  for  strengthening  Europe's 
biotechnology  and  biomanufacturing  sector  will  be  implemented  through  direct  and 
indirect  management,  using  the  implementation  modes  offered  by  the  Financial 
Regulation,  mainly  being  grants  and  procurement  for  the  direct  management  mode. 
Direct  management 
agreements/contracts  with 
beneficiaries/contractors  directly engaged in  activities that serve  Union policies. The 
Commission ensures direct monitoring over the outcome of the actions financed. The 
payment modalities of the actions funded will be adapted to the risks pertaining to the 
financial transactions. 

establish  grant 

allows 

to 

In  order  to  ensure  the  effectiveness,  efficiency  and  economy  of  the  Commission 
controls, the control strategy will be oriented towards a balance of ex-ante and ex-post 
checks and focus on three key stages of grant/contract implementation, in accordance 
with the Financial Regulation and/ or the specific contractual provisions: 

- Selection of proposals/award the contract to tenders that fit the policy objectives; 

-  Operational,  monitoring  and  (ex  ante)    technical  desk  reviews  that  cover  project 
implementation,  public  procurement,  pre-financing,  interim  and  final  payments, 
management of guarantees;  

-  Ex-post  controls  at  the  beneficiaries  will  also  be  carried  out  on  a  sample  of 
transactions. The selection of these transactions will combine a risk assessment and a 
random selection.  

The  annual  EU  subsidy  will  be  transferred  to  the  Agencies  in  accordance  with  their 
payment needs and upon their requests. The Agencies will be subject to administrative 
controls  including  budgetary  control,  internal  audit,  annual  reports  by  the  European 
Court  of  Auditors,  the  annual  discharge  for  the  execution  of  the  Union  budget  and 
possible investigations conducted by OLAF to ensure, in particular, that the resources 
allocated  to  the  Agencies  are  put  to  proper  use.  Through  its  representation  in  the 
Agencies'  Management  Board  and  Audit  Committee,  the  Commission  will  receive 
audit reports and ensures that adequate actions are defined and timely implemented by 
the Agencies to address the issues identified. All payments will remain pre-financing 
payments  until  the  Agencies’  accounts  have  been  audited  by  the  European  Court  of 
Auditors  and  the  Agencies  has  submitted  its  final  accounts.  If  necessary,  the 
Commission will recover unspent amounts of the instalments paid to the Agencies.  

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For provisions of this  Regulation  that require long-term  coordination and large-scale 
public  and  private  investment  (i.e.  for  high  impact  health  biotechnology  strategic 
projects),  the  Commission  may  propose  European  Partnerships  where  the  Union 
together  with  private  and/or  public  partners,  acting  in  full  compliance  with 
competition rules, commit to jointly supporting the development and implementation 
of  a  programme  activities,  including  those  related  to  market,  regulatory  or  policy 
uptake. 

The  activities  of  the  Agencies  will  also  be  subject  to  the  supervision  of  the 
Ombudsman  in  accordance  with  Article  228  of  the  Treaty.  These  administrative 
controls provide a number of procedural safeguards to ensure that account is taken of 
the interests of the stakeholders. 

2.2.2. 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them 

The  main  risks  relate  to  the  Agencies’  performance  and  independence  in 
impaired 
implementing 
independence could  hamper the  achievement of the objectives of this initiative and 
also reflect negatively on the Commission’s reputation.  

them.  Underperformance  or 

tasks  entrusted 

the 

to 

The Commission and the Agencies have put in place internal procedures that aim at 
covering  the  risks  identified  above.  The  internal  procedures  are  in  full  compliance 
with  the  Financial  Regulation  and  include  anti-fraud  measures  and  cost-benefit 
considerations.  

First and foremost, sufficient resources should be made available to the Agencies in 
both financial and staffing terms to achieve the objectives of this initiative. 

include  both 

Furthermore,  quality  management  will 
integrated  quality-
management  activities  and  risk-management  activities  within  the  Agencies.  A  risk 
review is conducted annually, with risks being assessed at a residual level, i.e. taking 
into account controls and mitigations already in place. Conducting self-assessments 
(as part of the EU Agencies benchmarking programme), annual reviews of sensitive 
functions and ex-post controls also fall within this area, as does maintain a register of 
exceptions.  

the 

To  preserve  impartiality  and  objectivity  in  every  aspect  of  the  Agencies’  work,  a 
number of policies and rules on management of competing interests have been put in 
place and will be regularly updated, describing specific arrangements, requirements 
and  processes  applying  to  the  Agencies’  Management  Board,  scientific  committee 
members and experts, the Agencies’ staff and candidates, as well as consultants and 
contractors.  The  Commission  will  be  informed  timely  of  relevant  management  and 
independence issues encountered by the Agencies and will react upon notified issues 
timely and adequately.  

The  proposal  also  envisages  that  the  Commission  promotes  Biotechnology 
Investment Pilot for biotechnology investment in the EU. 

The main risks are the following: 

•  Risk  of  not  fully  achieving  the  objectives  of  the  Regulation  due  to  insufficient 
uptake or quality/delays in the implementation of the selected projects or contracts; 

• Risk of inefficient or non-economic use of investments awarded; 

EN 

11 

  EN 

 
• Reputational risk for the Commission, if fraud or criminal activities are discovered; 
only  partial  assurance  can be drawn from  the third parties' internal control  systems 
due to the rather large number of heterogeneous contractors and beneficiaries, each 
operating their own control system. 

The  Commission  will  allocate  the  necessary  human  and  financial  resources  for  the 
proper  implementation  of  this  Regulation  and  will  put  in  place  internal  procedures 
that aim at covering the risks identified above. The internal procedures will be in full 
compliance with the Financial Regulation and include anti-fraud measures and cost-
benefit considerations. 

  . 

2.2.3.  Estimation  and  justification  of  the  cost-effectiveness  of  the  controls  (ratio  between 
the control costs  and the value of the related funds managed), and assessment of the 
expected levels of risk of error (at payment & at closure)  

the  Agencies’ 

The  Commission’s  and 
into 
consideration the main cost drivers, and the efforts already taken over several years 
to  reduce  the  cost  of  controls,  without  compromising  the  effectiveness  of  controls. 
The  existing  control  systems  proved  to  be  able  to  prevent  and/or  to  detect  errors 
and/or irregularities, and in case of errors or irregularities, to correct them.  

internal  control  strategies 

take 

In  the  past  five  years,  the  Commission’s  yearly  costs  of  controls  under  indirect 
management represented less than 1% of the annual budget spent on subsidies paid to 
the EMA and EFSA. The Agencies allocated less than 0,5% (EMA) and 5% (EFSA) 
of  their  total  annual  budget  on  control  activities  centring  around  integrated  quality 
management,  audit,  anti-fraud  measures,  finance  and  verification  processes, 
corporate risk management and self-assessment activities. 

 2.3.  Measures to prevent fraud and irregularities  

 Preventing  and  detecting  fraud  is  a  key  governance  issue  and  a  common  control 
objective  for  all  Commission’s  departments  who  have,  in  practical  terms,  the 
obligation  to  put  in  place  the  appropriate  management  and  internal  control 
procedures  designed  to  deter,  detect,  correct  or  sanction  irregularities  and  fraud,  in 
line with articles 317 and 325 TFEU and article 36 FR. 

As for its activities in  indirect  management, the  Commission  shall take appropriate 
measures ensuring that the financial interests of the European Union are protected by 
the application of preventive measures against fraud, corruption and any other illegal 
activities,  by  effective  checks  and,  if  irregularities  are  detected,  by  the  recovery  of 
the  amounts  wrongly  paid  and,  where  appropriate,  by  effective,  proportional  and 
deterrent  penalties.  To  this  effect,  the  Commission  adopted  an  anti-fraud  strategy, 
latest  update  of  April  2019  (COM(2019)176),  covering  preventive,  detective  and 
corrective measures. The Commission or its representatives and the European Court 
of Auditors shall have the power of audit, on the basis of documents and on-the-spot, 
over all grant beneficiaries, contractors and subcontractors who have received Union 
funds. OLAF shall be authorised to carry out on-the-spot checks and inspections on 
economic operators concerned indirectly by such funding.  

As regards the European Medicines Agency, the anti-fraud measures are provided for 
in  Article  69  of  Regulation  (EC)  No  726/2004  and  the  framework  financial 
Regulation  (2019/715).  The  Executive  Director  and  the  Management  Board  of  the 
Agency  will  take  the  appropriate  measures  in  accordance  with  the  Internal  Control 

EN 

12 

  EN 

 
Principles applied across all EU institutions. In line with the Common Approach and 
Article  42  of  the  framework  financial  Regulation,  an  anti-fraud  strategy  has  been 
developed and is followed by the Agency. The Agency’s Anti-fraud strategy covers 
3-year  period  and  is  accompanied  by  a  corresponding  action  plan,  outlining  both 
specific  focus  areas  and  actions  for  the  next  years,  and  several  continuous  actions 
that are carried out  every year, such as a specific standalone fraud risk assessment, 
with the identified fraud risks included in the overall Agency risk register. Anti-fraud 
trainings are organised as part of the induction training and via mandatory anti-fraud 
e-learning  training  for  newcomers.  Staff  are  made  aware  of  how  to  report  any 
suspects of wrongdoings and disciplinary procedures are in place as per the rules of 
the Staff Regulations. 

As  regards  the  European  Food  Safety  Authority,  the  anti-fraud  measures  are 
provided  for  in  Article  25  of  Regulation  (EC)  No  178/2002  and  the  framework 
financial  Regulation  (2019/715).  The  Management  Board  will  take  the  appropriate 
measures  in  accordance  with  the  Internal  Control  Principles  applied  across  all  EU 
institutions.  In  line  with  the  Common  Approach  and  Article  42  of  the  framework 
financial  Regulation,  an  anti-fraud  strategy  has  been  developed  and  is  followed  by 
the  Authority.  The  Authority’s  Anti-fraud  strategy 
is  accompained  by  a 
corresponding action plan, outlining both specific focus areas and actions for the next 
years,  and  several  continuous  actions  that  are  carried  out  every  year,  such  as  a 
specific standalone fraud risk assessment, with the identified fraud risks included in 
the overall Agency risk register. Mandatory anti-fraud trainings are organised as part 
of  the  awareness  anti-fraud  sessions.  Staff  are  made  aware  of  how  to  report  any 
suspects of wrongdoings and disciplinary procedures are in place as per the rules of 
the Staff Regulations. 

EN 

13 

  EN 

 
3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

•  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

other 
assigned 
revenue 

NO 

NO 

Heading 
of 
multiann
ual 
financial 
framewo
rk 

Number  

Budget line 

Type of 
expendit
ure 

Diff./No
n-diff.1 

from 
EFTA 
countri
es2 

Contribution  

from 
candidat
e 
countrie
s and 
potential 
candidat
es3 

From 
other 
third 
countri
es 

2 

2 

2 

4 

4  

4 

4  

Support expenditure of the programme  Non-diff  YES 

YES 

YES 

Union  contribution  to  the  European 
Medicines Agency  

Non-
diff. 

YES 

YES 

YES 

Union  contribution  to  the  European 
Food Safety Agency  

20  01  02  01  -  Headquarters  and 
Representation  offices  -  officials  and 
temporary staff  
20  02  01  and  20  02  02  –  External 
and 
personnel 
Representation offices  

–  Headquarters 

20 02 06 02 - Conference and meeting 
costs 

20  02  06  01  -  Missions,  conferences 
and representation expenses  

Diff. 

YES 

YES 

YES 

NO 

Non-
diff.  

Non-
diff.  

Non-
diff.  

Non-
diff.  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

NO  

1 
2 
3 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 

EN 

14 

  EN 

 
 
 
  
 
 
3.2. 

Estimated financial impact of the proposal on appropriations  

3.2.1. 

Summary of estimated impact on operational appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–   The proposal/initiative requires the use of operational appropriations, as explained below 

3.2.1.1.  Appropriations from voted budget 

Amounts are indicative and do not prejudge the outcome of the ongoing negotiations on the next MFF. 

                                                                                                                                              EUR million (to three decimal places) 

DG: SANTE 

Operational appropriations  

Programme Budget line 

Commitments 
Payments 

(1a) 
(2a) 

Year 

2028 

p.m.  
p.m.  

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
MFF 
2028-2034 

p.m.  
p.m.  

p.m.  
p.m.  

p.m.  
p.m.  

p.m.  
p.m.  

p.m.  
p.m.  

p.m.  
p.m.  

p.m. 
p.m. 

line 

-  Technical 

Appropriations of an administrative nature financed from the envelope of specific programmes 
Budget 
Assistance -Support credits 
TOTAL appropriations 
for DG SANTE 

Commitments  =1a+1b+3 
=2a+2b+3 
Payments 

2,626 
2,626 

2,626 
2,626 

2,626 

2,626 

2,626 
2,626 

2,626 

(3) 

2,626 

2,626 

2,626 

2,626 

18,382 

2,626 
2,626 

2,626 
2,626 

2,626 
2,626 

2,626 
2,626 

18,382 
18,382 

EN 

15 

EN 

 
 
  
 
 
 
 
 
 
 
EU contribution to decentralised agencies  

EUR million (to three decimal places) 

[Agency]: 
<EMA .> 

Budget line: 
EMA / EU 
Budget 
contribution to 
the agency 

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
2028 - 2034 

POST 
2034 annual 
expenditure) 

10,055 

8,153 

2,196 

2,240 

2,285 

2,330 

2,377 

29,635  2,425 

EFSA 

Budget line: EFSA/ EU Budget contribution to 
the agency 

Year 

2028 

Year 

Year 

2029 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
2028-
2034 

POST 
2034(annual 
expenditure) 

0,882 

1,800 

1,836 

1,872 

1,910 

1,948 

1,987 

12,235 

2,027 

EUR million (to three decimal places) 

For EFSA and EMA for the first year only 50 % of the average staff costs are taken into account as it is expected that not all positions will 
be filled from the beginning of the year 

EN 

16 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
Without prejudice to the negotiations on the next MFF, the appropriations allocated to the agencies from 2028 onwards will be compensated via 
redeployments from programmes under the 2028-2034 MFF. If a compensatory reduction is needed, the resources allocated to the agencies and 
their funding streams and sources may need to be revised. 

EUR million (to three decimal places)  

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
MFF 
2028-2034 

10,938 

9,953 

4,032 

4,112 

4,194 

4,278 

4,364 

41,870 

10,938 

9,953 

4,032 

4,112 

4,194 

4,278 

4,364 

41,870 

2,626 

2,626 

2,626 

2,626 

2,626 

2,626 

2,626 

18,382 

(4) 

(5) 

(6) 

Commitments 

TOTAL  operational 
appropriations  
(including 
contribution  to  EMA 
and EFSA) 
TOTAL 
an 
appropriations 
administrative  nature  financed  from 
the envelope for specific programmes  

Payments 

of 

TOTAL 
appropriations 
under HEADING 
SANTE 
of the multiannual 
financial framework 

Commitments  =4+6 

13,564 

12,579 

6,658 

6,738 

6,820 

6,904 

6,990 

60,252 

Payments 

=5+6 

13,564 

12,579 

6,658 

6,738 

6,820 

6,904 

6,990 

60,252 

Without  prejudice  to  the  negotiations  on  the  next  MFF,  the  appropriations  allocated  to  the  agencies  from  2028  onwards  will  be 
compensated  via  redeployments  from  programmes  under  the  2028-2034  MFF.  If  a  compensatory  reduction  is  needed,  the  resources 
allocated to the agencies and their funding streams and sources may need to be revised. 

EN 

17 

EN 

 
 
 
 
 
  
 
   EUR million (to three decimal places) 

Heading of multiannual financial  framework  

4 

‘Administrative expenditure’ 

DG: SANTE 

Year 

Year 

Year 

Year 

Year 

Year 

Year 

2028 

2029 

2030 

2031 

2032 

2033 

2034 

Human resources  
Other administrative expenditure  
TOTAL DG SANTE 

Appropriations  

6,371 
0,010 
6,381 

6,371 
0,010 
6,381 

6,371 
0,010 
6,381 

6,371 
0,011 
6,382 

6,371 
0,011 
6,382 

6,371 
0,011 
6,382 

6,371 
0,011 
6,382 

TOTAL 
MFF 
2028-
2034 
44,597 
0,075 
44,672 

TOTAL appropriations 
under HEADING 4 
of the multiannual financial framework  

(Total 
commitments 
= Total 
payments) 

6,381 

6,381 

6,381 

6,382 

6,382 

6,382 

6,382 

44,672 

–  Amounts are indicative and do not prejudge the outcome of the ongoing negotiations on the next MFF. 

EN 

18 

EN 

 
 
 
 
                                                                                                                                                                         
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Year 
2028 

Year 
2029 

Year 
2030 

Year 
2031 

Year 
2032 

Year 
2033 

Year 
2034 

TOTAL MFF 
2028-2034 

TOTAL HEADING 1 to 4 C1 

Commitments 

19,945 

18,960 

13,039 

13,120 

13,202 

13,286 

13,372 

104,924 

Payments 

19,945 

18,960 

13,039 

13,120 

13,202 

13,286 

13,372 

104,924 

TOTAL 
appropriations 
under 
HEADINGS 1 
to 4 
of the 
multiannual 
financial 
framework  

* Figures in the table above are all strictly indicative pending the outcome of the 2028-2034 MFF negotiations which cannot be prejudged. 

3.2.2.  Estimated output funded from operational appropriations (not to be completed for decentralised agencies) 

The output funded from operational appropriations cannot be calculated as the outcome of the 2028-2034 MFF negotiations, still ongoing  at time 
of completing the LFDS, cannot be prejudged. 

EN 

19 

EN 

 
 
  
 
 
 
 
 
3.2.3. 

Summary of estimated impact on administrative appropriations (not to be completed 
for decentralised agencies) 

–  ¨  The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature  

–  x  The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below 

–  3.2.3.1  Appropriations from voted budget 

VOTED 
APPROPRIATIONS 

Year  Year  Year  Year  Year  Year  Year  TOTAL 
2028 - 
2034 

2028  2029  2030  2031  2032  2033  2034 

POST 
2034(annual 
expenditure) 

HEADING 4 
Human resources  
Other administrative 
expenditure  

6,371  6,371  6,371  6,371  6,371  6,371  6,371 

44,597 

0,010  0,010  0,010  0,011  0,011  0,011  0,011 

0,075 

Subtotal HEADING 4 

6,381  6,381  6,381  6,382  6,382  6,382  6,382 

44,672 

Outside HEADING 4 
Human resources  
Other expenditure of an 
administrative nature 
Subtotal outside 
HEADING 4 

2,626  2,626  2,626  2,626  2,626  2,626  2,626 

18,382 

0,000  0,000  0,000  0,000  0,000  0,000  0,000 

0,000 

2,626  2,626  2,626  2,626  2,626  2,626  2,626 

18,382 

6,371 

0,011 

6,382 

2,626 

0,000 

2,626 

TOTAL 

9,007  9,007  9,007  9,008  9,008  9,008  9,008 

63,054 

9,008 

–  * Figures in the tables above are all strictly indicative pending the outcome of the 

2028-2034 MFF negotiations which cannot be prejudged. 

=================================================================== 

3.2.4.  Estimated  requirements  of  human  resources  (not  to  be  completed  for  decentralised 

agencies) 

–  ¨  The proposal/initiative does not require the use of human resources  

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below 

EN 

20 

  EN 

 
  
  
  
 
 
 
 
 
3.2.4.1.  Financed from voted budget 

Estimate to be expressed in full-time equivalent units (FTEs)1 

TOTAL 
VOTED APPROPRIATIONS  
+ 
EXTERNAL ASSIGNED 
REVENUES 

Year  Year  Year  Year  Year  Year  Year 

POST 

2028  2029  2030  2031  2032  2033  2034 

2034(annual 
expenditure) 

Establishment plan posts (officials and temporary staff) 

• External staff (in Full Time Equivalent unit: FTE) 

20 01 02 01 (Headquarters 

and Commission’s 
Representation Offices) 

20 01 02 03 (EU Delegations) 
01 01 01 01  (Indirect 

research) 

01 01 01 11 (Direct research) 
Other budget lines (specify) 

20 02 01 (AC, END from the 

‘global envelope’) 

20 02 03 (AC, AL, END and 

JPD in the EU Delegations) 
Admin. Support 
line 
[XX.01.YY.YY] 
[2] 

Headquarters 
- in EU 
Delegations  

- at 

01 01 01 02 (AC, END - 

Indirect research) 

 01 01 01 12 (AC, END - 

Direct research) 

Other budget lines (specify) - 

Heading 4 

Other budget lines (specify) - 

Outside Heading 4 

TOTAL 

29 

29 

29 

29 

29 

29 

29 

29 

0 

0 

0 
0 

0 

0 

0 
0 

0 

0 

0 
0 

9 

0 

0 

0 

0 

0 

0 

9 

0 

0 

0 

0 

0 

0 

9 

0 

0 

0 

0 

0 

0 

0 

0 

0 
0 

9 

0 

0 

0 

0 

0 

0 

0 

0 

0 
0 

9 

0 

0 

0 

0 

0 

0 

0 

0 

0 
0 

9 

0 

0 

0 

0 

0 

0 

0 

0 

0 
0 

9 

0 

0 

0 

0 

0 

0 

0 

0 

0 
0 

9 

0 

0 

0 

0 

0 

0 

26 

64 

26 

64 

26 

64 

26 

64 

26 

64 

26 

64 

26 

64 

26 

64 

* Figures in the tables above are all strictly indicative pending the outcome of the 2028-2034 
MFF negotiations which cannot be prejudged. 

Considering the overall strained situation in Heading 4, in terms of both staffing and the level of 
appropriations, the human resources required will be only partly met by staff from the DG who are 
already assigned to the management of the action and/or have been redeployed within the DG.   

1 

Please specify below the table how many FTEs within the number indicated are already assigned to the 
management of the action and/or can be redeployed within your DG and what are your net needs. 

EN 

21 

  EN 

 
 
  
  
 
 
24 additional establishment plan posts which are required to implement the proposal and 4 SNEs 
(in  FTEs) to  be covered with additional staff to  be  financed  under  heading  4.  26  CAs  will  be 
financed from appropriations  of  an  administrative  nature  financed  from  the  envelope  of  specific 
programmes.  5ADs,  4  CAs  and  1  SNE  posts  to  be  covered  by  current  staff  available  in  the 
Commission services.  

The staff required to implement the proposal (in FTEs):  

To be covered by 
current staff 
available in the 
Commission 
services  

Exceptional additional staff* 

To be financed 
under Heading 4 
or Research 

To be financed 
from BA line 

To be financed 
from fees 

Establishment 
plan posts 

5 ADs 

External 
staff 
(CA, SNEs, INT) 

4  CAs  (FIV)  and  1 
SNE 

19 ADs 

5 ASTs 

4 SNEs 

N/A 

20 CAs FGIV 

6 CAs FGIII 

The  provisions  of  the  Biotech  Act,  focused  on  health  and  food  applications  in  the 
biotechnology sector, were developed by a temporary taskforce in DG SANTE with support 
of line units fully resourced to other tasks across different directorates. To fully implement the 
Act's provisions — which aim to streamline and future proof the regulatory system, enhance 
research, development, manufacturing and financing of biotechnology products, enable use of 
AI,  foster  skills  and  safe  use  of  biotechnology  —  additional  dedicated  personnel  will  be 
needed, as presented in the table above and detailed below. 

Description of tasks to be carried out by SANTE: 

Officials 
and 
temporary 
staff 

24 FTEs (AD profiles) to: 

•  Manage  the  workload  related  to  the  revision  and  implementation  of  the  following 

legislation  

o  Amendment  to  Regulation  (EU)  2024/1938  (SoHO):  handle  increased 
number  of  cases  concerting  the  development  of  novel  nologysandboxes  in 
the field of SoHO.  

o  Amendments 

to  Regulation 

(EC)  No  1394/2007  on  Advanced 
Therapeutic  Medicinal  Products  (ATMPs):    draft  delegated  acts  in 
relation to what constitute an ATMP in line with amendments to Regulation 
(EC) No 1394/2007 foreseen by this Regulation. 

o  Amendments  to  Regulation  (EU)  No  536/2014  (‘Clinical  Trials 
Regulation’):  prepare  the  delegated  acts  and  implementing  acts  related  to 
the  changes  of  CTR,  support    the  work  of  expert  groups  developing 

EN 

22 

  EN 

 
 
 
 
 
 
 
guidance  and  best  practices,  coordinate  with  relevant  authorities  for 
coherence  with  other  regulatory  frameworks,  monitor  the  preparedness  of 
Member  States  for  the  harmonised  implementation  of  the  changes  to  the 
CTR,    monitor  and  steer  the  changes  to  the  Clinical  Trials  Information 
System. 

o  Amendments  to  Regulation  (EC)  No  178/2002  (‘General  Food  Law’): 
comment  on  behalf  of  the  Commission  prior  to  the  commencement  of  a 
proposed  regulatory  sandbox  and  of  any  adaptations  thereof;  Develop  of 
implementing  acts  , review annual  reports of Member States that have set 
up  regulatory  sandboxes,  proceed  to  the  necessary  adaptations  of  the 
applicable legislative framework where required. 

•  Manage  a  panel  of  experts  advising  the  Commission  on  new  biotechnology 

developments i.e., Foresight Panel for Emerging Health Innovation.  

•  Set  up  and  manage  the  regulatory  sandboxes  for  novel  health  biotechnology 

products not falling in any other legislation in the area of health.  

•  Develop  implementing  acts  as  needed,  detail  criteria,  draft  call  for  proposals  and 
follow  the  implementation  of  High  Impact  Health  Biotechnology  strategic 
projects  on:  biotechnology  research  and  development,  availability  of  late-stage 
capital, AI biotechnology applications and biosecurity.  

•  Draft  call  for  proposals  and  follow  the  implementation  of  innovative  and 
the  establishment  of  an  EU  Health 
precommercial  procurement  projects, 
Biotechnology  Support  Network  of  local  antennas  supporting  biotechnology 
undertakings;  

•  Provide policy and legal guidance to and coordinate with:  

o  EMA  on  AI  systems  Deployment  and  Use  in  the  Lifecycle  of  Medicinal 

Products.  

o  Implementing partners on the management of the Biotechnology Investment 

Pilot.  

o  Member States on the supervision of economic operators handling potential  

biosecurity risk products. 

5 (AST profiles) to:  

•  Provide  administrative  and  logistic  support  to  experts’  meetings  of  the  Advisory 
Group  on  Biosecurity  and  Artificial  Intelligence  and  to  meetings  of  Member 
States  and  the  Commission  in  the  European  Health  Biotechnology  Steering 
Group.  
 Support the process of projects selection and assessment for High Impact Health 
Biotechnology strategic projects and assist with information management. 

• 

•  Develop and maintain a Union Regulatory Status Repository to assist developers 

in navigating cases of health biotechnology products. 

External 
staff 

5 SNEs and 24 CAs (FGV) to support ADs with: 

•  Expert selection and appointment and dissemination of discussion papers produced 

EN 

23 

  EN 

 
by  the  Foresight  Panel  for  emerging  health  innovation,  support  content 
preparation of panels meetings.  

•  Setting  up  and  management  of  Regulatory  Sandbox  for  novel  health 
biotechnology products not falling in any other legislation in the area of health  
•  Commenting  on  proposed  regulatory  sandboxes  in  the  framework  of  the  General 

Food Law and with the development of implementing and delegated acts.  

•  Drafting  of  calls  for  proposal  for  Hight  Impact  Health  Biotechnology  Strategic 
Projects  and  follow  their  implementation,  in  different  areas  (biotechnology 
research  and  development,  availability  of  late-stage  capital,  AI  biotechnology 
applications and biosecurity) and for the establishment of the  and the EU Health 
Biotechnology Support Network. 

•  Providing technical content development of the AI-Biotechnology Support Module 
and its  continued maintenance  and update with  information  to  be disseminated by 
the Biotechnology Support Network. 

•  Ensuring  coordination  in  management  of  funding  and  liaison  with  implementing 

partners in the context of the EU Biotechnology Investment Pilot. 

•  Drafting of guidelines on the enforcement of biosecurity provision to be enforced in 
cooperation  with  Member  States  and  relevant  delegated  or  implementing  acts, 
monitor  and  analyse    landscape  to  identify  promising  technologies  and  to  support 
ADs in developing and following calls for capability projects. 

•  Preparing  meeting  content  and  support  management  of  the  meetings  of  the 
Advisory  Group  on  Biosecurity  and  Artificial  Intelligence  and  the  European 
Health Biotechnology Steering Group. 

6 CAs (FGIII) to: 

•  Provide  administrative  support  to  the  organisation  of  the  experts’  meetings  of  the 

Foresight Panel for emerging health innovation. 

•  Promote and facilitate the networking and cooperation among projects and maintain 

updated lists of High Impact Health Biotechnology Strategic Project. 

•  Support  with  workflow  of  queries  and  management  of  information  of  the  EU 

Health Biotechnology Support Network. 

3.2.5.  Overview  of  estimated  impact  on  digital  technology-related  investments  (not  to  be 

completed for decentralised agencies) 

Compulsory: the best estimate of the digital technology-related investments entailed 
by the proposal/initiative should be included in the table below.  

Exceptionally,  when  required  for  the  implementation  of  the  proposal/initiative,  the 
appropriations under Heading 4 should be presented in the designated line.  

The appropriations under Headings 1-3 should be reflected as “Policy IT expenditure 
on operational programmes”. This expenditure refers to the operational budget to be 
used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation 
of the initiative and their associated investments (e.g. licences, studies, data storage 
etc).  The  information  provided  in  this  table  should  be  consistent  with  details 
presented under Section 4 “Digital dimensions”. 

TOTAL 
Digital and IT 

Year 

Year 

Year 

Year 

Year 

Year 

Year 

TOTAL 
MFF 

EN 

24 

  EN 

 
appropriations 

HEADING 4 

IT expenditure 
(corporate)  

Subtotal 
HEADING 4 
Outside HEADING 4 

Policy IT 
expenditure on 
operational 
programmes 

Subtotal 
outside 
HEADING 4 

TOTAL 

2028 

2029 

2030 

2031 

2032 

2033 

2034 

2028 - 
2034 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

3.2.6.  Compatibility with the current multiannual financial framework (not to be completed 

for decentralised agencies) 

The proposal/initiative: 

–   can be fully financed through redeployment within the relevant heading of the 

multiannual financial framework (MFF) 

The initiative will be fully financed via redeployments from programmes under the 
2028-2034 MFF  

–  ¨ 

requires use of the unallocated margin under the relevant heading of the MFF 

and/or use of the special instruments as defined in the MFF Regulation 

–  ¨ 

requires a revision of the MFF 

3.2.7.  Third-party contributions (not to be completed for decentralised agencies) 

The proposal/initiative: 

–   

does not provide for co-financing by third parties  

–    provides for the co-financing by third parties estimated below: 

Appropriations in EUR million (to three decimal places) 

Year   Year   Year   Year   Year   Year   Year  
2034 
2031 
2028 

2033 

2029 

2032 

2030 

Total 

the 

Specify 
co-financing 
body  

EN 

25 

  EN 

 
  
 
 
  
  
  
  
  
  
  
  
  
TOTAL 
appropriations 
co-financed  

3.2.8.  Estimated human resources and the use of appropriations required in EMA  

. 

Staff requirements (full-time equivalent units) 

[Agency]: <EMA .> 

Year  Year  Year  Year  Year  Year  Year  POST 

Temporary agents (AD 
Grades) 
Temporary agents (AST 
grades) 
Temporary agents 
(AD+AST) subtotal 

Contract staff 

Seconded National Experts 

Contract agents and SNE 
subtotal 

TOTAL staff 

2028  2029  2030  2031  2032  2033  2034 

2034 

5 

2 

7 

5 

5 

12 

5 

2 

7 

5 

5 

5 

2 

7 

5 

5 

5 

2 

7 

5 

5 

5 

2 

7 

5 

5 

5 

2 

7 

5 

5 

5 

2 

7 

5 

5 

12 

12 

12 

12 

12 

12 

5 

2 

7 

5 

5 

12 

Appropriations  covered  by  the  EU  budget  contribution  in  EUR  million  (to  three  decimal 
places) 

[Agency]: 
<EMA .> 

Title 1: Staff 
expenditure 
Title 2: 
Infrastructure 
and operating 
expenditure ( 
IT investments) 
= 
Title 3: 
Operational 
expenditure 

Year  Year  Year  Year  Year  Year  Year  TOTAL 
2028 - 
2034 

2029  2030  2031 

2032  2033  2034 

2028 

POST 
2034(annual 
expenditure) 

1,055 

2,153 

2,196 

2,240 

2,285 

2,330 

2,377 

14,635 

2,425 

9,000  6,000 

15,000 

0,000 

EN 

26 

  EN 

 
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
TOTAL of 
appropriations 
covered by the 
EU Budget  

10,055 

8,153 

2,196 

2,240 

2,285 

2,330 

2,377 

29,635 

2,425 

IT investments: EMA currently maintains the Clinical Trials Information System (CTIS) 
development and maintenance. This Regulation contains major new provisions directly 
impacting CTIS and need its strengthening. The core objectives of the amendments to the 
Clinical Trials Regulation (EU 526/2014) will be implementable only following significant IT 
developments and establishment of new workflows. We anticipate that these new provisions 
will necessitate fundamental redesign and build of CTIS followed by long-term maintenance 
including technology refresh.  

Overview/summary of human resources and appropriations (in EUR million) required 
by the proposal/initiative in a decentralised agency  

[Agency]: <EMA .> 

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
2028 - 
2034 

POST 
2034 

Temporary agents 
(AD+AST) 

Contract agents 

Seconded National Experts 

7 

5 

0 

7 

5 

0 

7 

5 

0 

7 

5 

0 

7 

5 

0 

7 

5 

0 

7 

5 

0 

Total staff 

12 

12 

12 

12 

12 

12 

12 

12 

5 

12 

Appropriations covered by 
the EU Budget 

Appropriations covered by 
fees 

Appropriations co-financed 
(if applicable) 

10,055 

8,153 

2,196 

2,240 

2,285 

2,330 

2,377 

29,635 

2,425 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

TOTAL appropriations 

10,055 

8,153 

2,196 

2,240 

2,285 

2,330 

2,377 

29,635 

2,425 

Appropriations covered by fees: Veterinary sandboxes established in this Regulation will be 
supported by fees, however being a completely new use case for which EMA will not be able 
to establish the fee level before the coming into effect of this Regulation, it is impossible to 
establish an amount and assess the level of contribution at this stage. 

Without  prejudice  to  the  negotiations  on  the  next  MFF,  the  appropriations  allocated  to  the 
agencies from 2028 onwards will be compensated via redeployments from programmes under 
the  2028-2034  MFF.  If  a  compensatory  reduction  is  needed,  the  resources  allocated  to  the 
agencies and their funding streams and sources may need to be revised. 

Description of tasks to be carried out by the European Medicines Agency (EMA): 

Officials  and  temporary 
staff 

The  Biotech  Act  proposal  will  contain  major  new  provisions  on  the 
management  of  Clinical  Trials.  These  include  multiple  new  workflows, 
parallel  submissions,  amended  dossier  requirement,  a  core  product  dossier 
and  extension  to  combined  studies    including  in-vitro  diagnostics,  among 
others.  

The requested 5 ADs will be:   

•  Managing the  significantly  increased  daily  operations  of  Clinical  Trial 

EN 

27 

  EN 

 
  
  
  
  
  
Information System (CTIS) including the access and tasks of its >20,000 
users and close to 3000 initial clinical trial applications and thousands 
of substantial modification applications.  

• 

Identifying, designing, reviewing and ensuring oversight 
of the delivery process  for new  functionalities  and  modules in  CTIS in 
line with relevant legal provisions.  

•  Monitoring the performance of the contractor,  

•  Working  with  CTIS 

stakeholders, 
to prioritise and  validate  CTIS technical  specifications,  in  line  with 
relevant legal provisions.  

subject  matter 

experts and 

•  Performing CTIS testing  activities, including for  the new functionalities 

and modules.  

•  Planning and performing change management activities. 

•  Performing communication, engagement and 

training of  all 
stakeholders (e.g. sponsors, Member State  regulatory bodies ).  

relevant 

•  Maintaining the training materials up to date.  

•  Monitoring the KPIs of the IT system and the CTR for regular reporting  

•  Delivering reports when requested  

•  Regulatory compliance check of the IT system  

2 AST will: 

•  Support  AD  organization  of  meetings  with  sponsors  and/or  experts  and 

drafting minutes. 

•  Support and coordinate engagement with CTIS subject matter experts and 

stakeholders. 

Support  and  coordinate  communication  and  training  activities  with 
sponsors, member state authorities, ethics bodies etc. 

External staff 

The requested 5 FTE will be supporting ADs in: 

•  Overall  support  to  the  ADs,  and  as  appropriate,  in  the  case  of  national 

experts, they provide expertise  

• 

Implementation of the development plan  

•  Contribute to coordination tasks 

•  Maintaining continuous availability and operation of CTIS.  

•  Managing post-delivery  maintenance,  providing  support  to  relevant 

EN 

28 

  EN 

 
stakeholders (e.g. IT and business service desk).   

•  performing continuous  monitoring 

of 

the 

CTIS 

function 

and performance.  

•  Providing programme and project management.  

•  Response to queries from stakeholders 

•  Support the development of CTIS training material  

•  Stakeholder communication (e.g. CTIS Forum and other events) 

  are  absolutely  necessary 

The  extra  resources 
timely 
implementation  of  the  amendments  targeting  competitiveness  are 
dependent on substantial IT development that would need to be set up in 
short time.  

since 

3.2.9.  Estimated human resources and the use of appropriations required in EFSA  

Staff requirements (full-time equivalent units) 

[Agency]: <EFSA> 

Year  Year  Year  Year  Year  Year  Year  POST 

2028 

2029 

2030 

2031 

2032 

2033 

2034 

2034 

Temporary agents (AD Grades) 

Temporary agents (AST 
grades) 

Temporary agents (AD+AST) 
subtotal 
Contract staff 
Seconded National Experts 
Contract agents and SNE 
subtotal 
TOTAL staff 

5 

1 

6 

8 

5 

1 

6 

8 

5 

1 

6 

8 

5 

1 

6 

8 

5 

1 

6 

8 

5 

1 

6 

8 

5 

1 

6 

8 

8 

14 

8 

14 

8 

14 

8 

14 

8 

14 

8 

14 

8 

14 

5 

1 

6 

8  

8 

14 

EN 

29 

  EN 

 
 
 
 
 
  
  
  
  
  
  
  
  
  
 
 
 
Overview/summary of human resources and appropriations (in EUR million) required 
by the proposal/initiative in a decentralised agency  

Year  Year  Year  Year  Year  Year  Year  TOTA

[Agency]: 
<EFSA> 

202
8 

202
9 

203
0 

203
1 

203
2 

203
3 

203
4 

L 
2028 - 
2034 

POST 
2034(annual 
expenditure
) 

Title 1: Staff 
expenditure 
Title 2: 
Infrastructure 
and operating 
expenditure 
Title 3: 
Operational 
expenditure 
TOTAL of 
appropriation
s covered by 
the EU Budget  

0,882  1,800  1,836  1,872  1,910  1,948  1,987 

12,235 

2,027 

0,000 

0,000 

0,882  1,800  1,836  1,872  1,910  1,948  1,987 

12,235 

2,027 

[Agency]: <EFSA> 

Year 

2028 

Year 

2029 

Year 

2030 

Year 

2031 

Year 

2032 

Year 

2033 

Year 

2034 

TOTAL 
2028 - 
2034 

POST 
2034 

Temporary agents 
(AD+AST) 

Contract agents 

Seconded National Experts 

6 

8 

0 

6 

8 

0 

6 

8 

0 

6 

8 

0 

6 

8 

0 

6 

8 

0 

6 

8 

0 

Total staff 

14 

14 

14 

14 

14 

14 

14 

6 

8 

14 

Appropriations covered by 
the EU Budget 

Appropriations covered by 
fees 

Appropriations co-financed 
(if applicable) 

0,882 

1,800 

1,836 

1,872 

1,910 

1,948 

1,987 

12,235 

2,027 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

TOTAL appropriations 

0,882 

1,800 

1,836 

1,872 

1,910 

1,948 

1,987 

12,235 

2,027 

EN 

30 

  EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
  
  
  
  
  
 
 
Without prejudice to the negotiations on the next MFF, the appropriations allocated to the 
agencies from 2028 onwards will be compensated via redeployments from programmes under 
the 2028-2034 MFF. If a compensatory reduction is needed, the resources allocated to the 
agencies and their funding streams and sources may need to be revised. 

Description of tasks to be carried out by the European Food Safety Agency (EFSA): 

Officials and temporary staff 

Currently,  there  are  a  lot  of  delays  during  the  EU  risk  assessment  as 
EFSA receives low quality dossiers, for which it has to frequently stop 
the  EU  risk  assessment  process  and  request  applicants  to  provide 
clarifications and/or additional information. To enhance innovation and 
to  ensure 
that  applicants,  and  especially  SMEs,  submit  high 
quality/comprehensive  application  dossiers  it  is  imperative  to  support 
them  at  pre-submission  phase.  This  will  ensure  that  the  EU  risk 
assessment finishes within the time provided increasing the applicants’ 
chances  of  reaching  the  market  as  quickly  as  they  can  (while  keeping 
funding from investors).  

Currently  EFSA  provides  pre-submission  advice  only  as  regards  what 
an  application  dossier  needs  to  contain  (administrative/regulatory 
aspects). Given the restricted scope of pre-submission advice (PSA), the 
uptake of the existing PSA is limited; applicants primarily need support 
on the scientific aspects of preparing a dossier.  

The  provisions  of  the  Biotech  Act  will  significantly  increase  EFSA 
workload, in  particular  due to the enlarged scope of PSA which will 
now cover also scientific advice (i.e. what kind of studies, advice on 
the  appropriate  study  design  depending  on  the  subject  matter  at 
issue,  etc).  Given  the  considerable  attractiveness  of  the  proposed 
changes for applicants, especially for SMEs, this is expected to result in 
a  significant 
increased  uptake  of  pre-submission  advice  (PSA) 
especially  by  SMEs  both  in  terms  of  numbers  of  requests  for  pre-
submission advice but also in the breadth and coverage of advice to be 
given.  

As  regards  numbers,  EFSA  expects  about  200  requests  per  year 
across all authorisation domains in the food chain – which are many 
and  diverse  –  both  for  new  products/substances  and  renewals  where 
applicable  (e.g.  novel  foods,  food  additives/enzymes/flavourings,  feed 
additives,  plant  protection  products,  maximum  residue  limits  of 
pesticides,  GM  food  and  feed,  food  contact  materials,  health  claims, 

EN 

31 

  EN 

 
 
 
 
 
addition of vitamins and minerals and other substances to foods, etc). 

As  regards  the  breadth  and  coverage  of  the  advice  to  be  given,  EFSA 
will now be required to carry out a closer evaluation of the request at 
both 
tailor-made 
hand 
administrative/regulatory  aspects  but  also  scientific  aspects  on  each 
individual case.  

covering 

provide 

advice 

and 

 Thus, the requested -5 ADs are necessary to: 

to 

studies 

in 
the 

support 
content 

-  Prepare  and  provide  tailor-made  pre-submission  advice 
consisting of scientific advice including  on the type and design 
an 
submitted 
be 
of 
application/notification 
the 
on 
and 
application/notification  at  hand.  The  scientific  advice  will  be 
particularly demanding as it needs to be specific to the needs of 
each induvial application taking also into account the profile of 
the  applicant  at  hand  (e.g.  SME  that  has  no  experience  with 
applications)  as  well  as  the  subject  matter  (type  of  product, 
applicable  sectoral  legislation,  type  of  approval,  e.g.  new  or 
renewal etc). This includes additional tasks such as:  

of 
of 

o  coordinate  with  subject  matter  units  for  the  needed 
tasks,  involvement  of  working  group  Experts,  Panel 
experts,  who  might  also  later  be  involved  in  dossier 
assessment;  In  this  respect,  additional  research  and 
work  would  need  to  be  carried  out  as  regards 
previous  scientific  outputs  of  the  EFSA  of  all  11 
Panels across all authorisation procedures in the food 
chain, data requirements set out in sectoral legislation 
and  all  relevant  scientific  guidances,  where  such  exist 
as well as the latest scientific information that may be 
relevant for the applicant concerned;  

o  coordinate  with  Member  State  experts  in  the  relevant 
EFSA  networks/fora  but  also  with  other  EU  agencies 
where  needed  –  in  the  area  of  pesticides  where  the 
semi-
approval 
decentralised 
to 
coordinate with the relevant MS authorities to ensure the 
provision  of  PSA  from  EFSA  and  from  the  MS 
authorities in a consistent manner; 

this  will  need  additional  effort 

system  of  active 

substances 

is 

o  exchange with the requestor (on acceptability, requests 

for clarifications);  

o  regular consultation with EFSA’s legal department to 
provide advice in line with the applicable rules (remit of 
pre-submission  advice,  public  disclosure  of  the  advice 

EN 

32 

  EN 

 
to  all 

given  once  corresponding  valid  applications  are  made 
etc.)  ensure  the  clarity  and  consistency  of  the  pre-
submission  advice 
requestors  across  all 
authorisation  procedures,  especially  where  applicants 
would  need  to  apply  for  more  than  1  authorisation 
process  for  placing  products  on  the  market  (application 
for novel foods and subsequently application for a health 
claim); 

o  coordinate  the  timely  handling  of  all  PSA  requests  in  a 
manner  that  provides  added  value  to  the  applicants  and 
ensure  that  high  quality  dossiers  are  subsequently 
submitted.  

- 

-  promotion  of  the  pre-submission  advice  provided  by  EFSA 
upon request  among applicants and particularly  SMEs, who are 
often  one-time  applicant  and  have  no  experience  on  how  to 
prepare application dossiers for risk assessment purposes; 
to  effectively  explain  the  ‘pre-submission  advice  (PSA)’ 
process to potential requestors;  
to  ensure  appropriate  training  to  the  subject  matter  units 
and/or relevant experts both on the required content of dossiers 
and  on  the  scientific  front  taking  into  account  the  EFSA 
scientific guidance documents and data requirements laid down 
in the sector specific legislation. 

- 

The permanent 5 AD positions will ensure clarity and consistency in the 
provision  of  PSA,  maintain  the  uptake  of  PSA  to  ensure  that  high 
quality  dossiers  are  later  submitted  that  would  accelerate  the  risk 
assessment process and that the knowledge is retained within EFSA in 
the most effective manner.  

1 Assistant staff (AST) is needed for: 

-  organization  of  tele-meetings  with  the  requestor  and/or  experts 

(if needed) and drafting minutes; 

-  developing a knowledge database and ensuring its maintenance, 

- 

- 

monitoring, reporting, auditing of the requests; 
following up on the continuous improvement of the service and 
support IT tool improvements;  
supporting applicants on the characteristics of the service and the 
IT Tools;  
-  disseminating 
supporting 
the  publication  of  summary 
publication of full advice at the time of a validated dossier. 

the  service  among  applicants  and  SMEs, 
in  Open  EFSA, 

External staff 

Given  the  expected  considerable  increased  uptake  of  the  PSA  in  the 

EN 

33 

  EN 

 
early  years  of  entry  into  application  of  this  enlarged  service,  the 
permanent  staff  would  need  the  support  of  8  CAs  (FGIV)  to  set  in 
motion the relevant process and the establishment/maintenance in terms 
of  content  of  a  knowledge  database  for  future  use  for  all  the  tasks 
outlined  and  for  all  authorisation  procedures  across  the  food  chain  for 
which  EFSA 
to  provide  scientific  advice.  More 
specifically:  

is  responsible 

- 

-  perform reception and triage of the request; 
- 

analyse the request and ensure appropriate understanding what is 
needed to provide tailor-made advice;  
liaise  with  the  technical  units  and  identify  the  relevant  and 
appropriate  profile  of  scientific  experts  (either  from 
the 
established  panels  or  their  working  groups  or  even  from  the 
reserve list of experts) that could support the scientific aspects of 
PSA  depending  on  each  individual  request;  ensure  their 
participation, analysis and input to the provision of the PSA; 
-  perform  literature  review  and  preparatory  work  to  support  the 
scientific  experts  and  ensure  also  the  provision  of  PSA  on 
administrative/regulatory aspects; 

-  exchanges  with  the  requestor  (on  acceptability,  requests  for 
clarifications) and setting up where appropriate PSA meetings; 
- 
review of written replies and summaries to ensure consistency;  
-  ensure that the replies provided are introduced into a  knowledge 
database to keep records of past advice for future use depending 
on the relevant needs of the requests at hand; 

-  drafting  of  the  written  advice  to  be  sent  to  the  requestor, 
finalisation of the advice and ensure that public disclosure of the 
PSA advice does not contain personal data or other confidential 
information.  

If  such  staffing  is  not  guaranteed  and  given  the  considerable 
increase of PSA that is expected, EFSA would not be able to deliver 
on  the  PSA  advice  without  moving  staff  from  its  ‘core  business’  – 
which is the provision of risk assessment – to the pre-submission phase. 
This  will  result  in  even  more  delays  than  currently  occur  in  the 
delivery  of  scientific  outputs,  defeating  the  very  purpose  of  the 
Biotech act, which is to stimulate innovation and ensure that the time to 
the market for innovators is reduced.  

Therefore, it is absolutely imperative for ensuring the objectives of the 
Biotech  act  to  guarantee  the  EFSA  additional  resources  so  as  to  avoid 
any direct negative impact on the timeliness and speed of delivery of 
scientific opinions.. 

EN 

34 

  EN 

 
 
3.3. 

Estimated impact on revenue  

–  The proposal/initiative has no financial impact on revenue. 

–  The proposal/initiative has the following financial impact: 

– 

– 

– 

on own resources  

on other revenue 

please indicate, if the revenue is assigned to expenditure lines 

     EUR million (to three decimal places) 

Impact of the proposal/initiative2 

Year 
2028 

Year 
2029 

Year 
2030 

Year 
2031 

Year 
2032 

Year 
2033 

Year 
2034 

Budget  revenue 
line: 

Appropriations 
available for 
the current 
financial year 

Article 
…………. 

For assigned revenue, specify the budget expenditure line(s) affected. 

[…] 

Other  remarks  (e.g.  method/formula  used  for  calculating  the  impact  on  revenue  or 
any other information). 

[…] 

4. 

DIGITAL DIMENSIONS  

4.1. 

Requirements of digital relevance 

High-level description of the requirements of digital relevance and related categories (data, 
process digitalisation & automation, digital solutions and/or digital public services)  

Reference  to  the 
requirement 

Requirement 
description 

1b 

[3] 

Article 
Health 
Biotechnology 
Strategic Projects  

Scaling-up or 
upgrading critical 
research and 
technology 
infrastructures 
underpinning the 
development, 

Actors 
affected or 
concerned by 
the 
requirement 

High-level 
Processes 

Categories 

Member  State 
authorities, 
Research 
organisations, 
Biotechnology 
industry actors 

Technical 
documentation, 
Data 
generation, 
Data processing 

Data,  Digital 
Solution   

2 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20% for collection costs. 

EN 

35 

  EN 

 
 
 
 
 
 
 
 
 
 
 
testing and 
validation of 
biotechnology 
products, 
including but not 
limited to pilot or 
testing 
infrastructures for 
biomanufacturing, 
data and digital 
platforms;  
accelerating 
innovation and 
technology 
deployment 
through one or 
more of the 
following features: 
(i) introducing or 
scaling up 
breakthrough 
innovations in 
biotechnology that 
have the potential 
to strengthen the 
Union’s industrial 
competitiveness, 
including AI-
enabled 
technologies and 
tools; 

the 
project 
contributes  to  the 
development 
of 
testing 
trusted 
environments 
for 
AI-enabled 
biotechnology 
innovations, 
the 
fulfilling 
laid 
conditions 
down 
in  Article 
[36], paragraph [1] 
is 
it 
or 
Biotechnology 
Data 

Quality 

Commission, 
Member  State 
authorities, 
Research 
organisations, 
Biotechnology 
industry actors 

Technical 
documentation, 
Data 
generation, 
Data processing 

Data,  Digital 
Solution 

Data 
generation, 
Data processing 

Data,  Digital 
Solution 

 Commission, 
Member  State 
authorities, 
Research 
organisations, 
Biotechnology 
industry actors 

1c 

[3] 

Article 
Health 
Biotechnology 
Strategic Projects  

Article  [4]  1d  High 
Health 
Impact 
Biotechnology 
Strategic Projects  

EN 

36 

  EN 

 
Data 
generation, 
Data processing 

Data,  Digital 
Solution 

Commission, 
Member  State 
authorities, 
Research 
organisations, 
Biotechnology 
industry actors 

Article [5] a  

Biotechnology 
Development 
Accelerator 

Accelerator  High 
Project, 
Impact 
the 
fulfilling 
conditions 
laid 
down 
in  Article 
[37] 

real-

it  provides  trusted 
or 
testing 
demonstration 
facilities 
replicating 
world 
biomanufacturing 
processes, 
including  general 
manufacturing 
practices  (GMPs) 
compliant 
processes,  or  their 
enabling 
technologies, 
process 
validation, 
small 
manufacturing, 
including  for  the 
initial  phases  of 
clinical trials; such 
enabling 
technologies  may 
include 
digital 
technologies, 
including  AI  with 
specific 
applicability 
in 
biotechnology  and 
biomanufacturing;  

for 
testing, 
and 
batch 

Technical 
documentation, 
Information 
exchange 

Data,  Digital 
Solution 

c 

Article 
[5] 
Biotechnology 
Development 
Accelerator 

Commission, 
Member  State 
authorities, 
Research 
organisations, 
Biotechnology 
industry actors 

it  aims  to  support 
hands-on 
and 
work-based 
training 
programmes 
aligned  with 
the 
Union’s  skills  and 
workforce 
development 
objectives  in  the 
biotechnology  and 
biomanufacturing 

EN 

37 

  EN 

 
or 

in 
to 

sectors 
relation 
enabling 
technologies,  such 
as 
digital 
technologies 
including  AI,  with 
specific 
in 
applicability 
biotechnology  and 
biomanufacturing; 

Research 
organisations, 
Biotechnology 
industry actors 

Data 
generation,  data 
processing 

Data,  Digital 
Solution 

Member  State 
authorities 

Reuse 
existing data 

of 

Data 

d 

[5] 
Article 
Biotechnology 
Development 
Accelerator 

Article [11] 7 

Single  Points  of 
Contact 

it conducts applied 
research 
in 
biotechnology  or 
biomanufacturing, 
or  in  relation  to 
enabling 
technologies,  such 
digital 
as 
technologies 
including  AI,  with 
specific 
in 
applicability 
biotechnology  and 
biomanufacturing 

Member 
States 
shall  promote  the 
reuse  of  existing 
data,  studies  and 
authorisations 
in 
avoid 
order 
to 
duplication 
of 
procedures, reduce 
administrative 
burden  and  ensure 
of 
consistency 
decision-making. 
For  that  purpose, 
they  shall  ensure 
when 
that, 
assessing 
an 
application, 
competent 
duly 
authorities 
take  into  account 
all 
relevant 
studies, 
assessments 
and 
valid  permits  or 

EN 

38 

  EN 

 
authorisations 
already carried out 
or  issued  for  the 
same project or its 
components, 
provided  that  they 
remain  applicable 
and up to date. 

Such  networking 
and 
cooperation 
should  aim  to:  e) 
the 
promote 
development 
of 
interoperable 
infrastructure  and 
digital  platforms, 
and  AI-enabled 
technologies 
supporting 
biotechnology  and 
biomanufacturing 

access  by  a  non-
associated 
third 
country  or  by  a 
non-associated 
third-country 
entity  to  sensitive 
information 
is 
prevented  and  the 
employees 
or 
persons 
other 
have 
involved 
security 
national 
clearance 
issued 
by a Member State 
or  an  associated 
country, 
where 
appropriate; 

and 
of, 

intellectual 
property 
arising 
from, 
the 
results 
the 
related 
activities 
to  the  access  to 
infrastructures  and 
remain 
datasets 
legal 
within 
is 
entity 

the 
that 

[15] 

Article 
2e 
Networks  of  Health 
Biotechnology 
Clusters 

[16] 

6a 
Article 
Access  Principles 
and 
Security 
Safeguards 

[16] 

6b 
Article 
Access  Principles 
and 
Security 
Safeguards 

EN 

Information 
exchange 

Data 

Access to data  Data 

to 

Access 
infrastructures 
and datasets 

Data 

Commission, 
Member  State 
authorities, 
Research 
organisations, 
Biotechnology 
industry actors 

Non-
associated 
third  country, 
Non-
associated 
third-country 
entity, 
Member 
States, 
Associated 
countries 

Non-
associated 
third  country, 
Non-
associated 
third-country 
entity, 
Member 
States, 
Associated 

39 

  EN 

 
  
  
countries 

Mapping 

Data 

Union  bodies 
and  agencies, 
industry 
stakeholders 
and 
organisations 

research 

granted 
access, 
during  and  after 
such  access,  are 
to 
not 
subject 
control 
or 
restriction  by  a 
non-associated 
third country or by 
a  non-associated 
third-country 
and 
entity, 
are 
neither 
exported 
outside  the  Union 
or 
outside 
associated 
nor 
countries 
accessible 
from 
outside  the  Union 
or 
outside 
associated 
countries  without 
the approval of the 
Member  State  or 
associated 
the 
country  in  which 
the  legal  entity  is 
established  and  in 
accordance  with 
the  objectives  of 
this Regulation 

use  of  data  and 
artificial 
intelligence, 
by 
assessing access to 
computing 
data, 
and 
digital 
infrastructures  for 
biotechnology  and 
identifying 
opportunities 
to 
foster  responsible 
AI-enabled 
innovation 
and 
contribute  to  the 
of 
mitigation 
related risks. 

[17] 

Article 
2e 
Strategic  Mapping 
of 
the  Union’s 
Biotechnology 
Ecosystem 

Article [21] 5a 

Composition 

and 

facilitate 
exchange 
information 

the 
of 
and 

of 
Steering 

Members 
the 
Group, 

Information 
exchange 

Data,  Digital 
Public Service 

EN 

40 

  EN 

 
Commission, 
Member  State 
authorities, 
research 
organisations, 
biotechnology 
industry actors 

Commission, 
Member  State 
authorities 

Information 
exchange 

Data,  Digital 
public service 

Member  State 
authorities 

Use of platform 
technologies 

Data 

Functioning  of  the 
Steering Group 

 Article [21] 5h 

Composition 
and 
Functioning  of  the 
Steering Group 

Article [29]b 

Health 
Biotechnology 
Strategic  Projects 
for Biosimilars 

in 
the 
and 

best 
practices 
among  Member 
States, 
the 
Commission,  and 
relevant 
stakeholders 
relation 
to 
recognition 
the 
implementation  of 
health 
biotechnology 
strategic  projects 
and  high 
impact 
health 
biotechnology 
strategic projects; 

the 
facilitate 
coordination  and 
information 
exchange  among 
the Member States 
on  enforcement  of 
the 
biosecurity 
provisions  in  this 
regulation 
and 
other 
emerging 
biosecurity  topics 
as  provided  for  in 
Article 

of 

to 
it  contributes 
the 
research, 
development  and 
marketing 
authorisation 
biosimilar 
products, 
and 
where  appropriate 
to  strengthen  the 
use  of  platform 
technologies. 
It 
includes  analytical 
methodologies 
that  would  reduce 
the 
for 
need 
clinical  data  for 
biosimilar 

EN 

41 

  EN 

 
  
Technical 
documentation 

Commission, 
EU  Agencies, 
Member  State 
authorities, 
industry 
stakeholders 
and 
organisations 

research 

Article [31] 

Guidance  on 
the 
deployment and use 
of systems based on 
advanced 
technologies, 
including  AI,  in  the 
lifecycle 
of 
medicinal products 

medicinal 
products,  without 
affecting 
their 
quality,  safety  and 
efficacy. 

The 
European 
Medicines Agency 
Agency’) 
(‘the 
develop 
shall 
the 
guidance  on 
deployment 
and 
use  of  artificial-
intelligence 
systems 
(‘AI 
systems’)  and  of 
general-purpose 
AI  models  in  the 
lifecycle 
of 
medicinal 
products 
development, 
including  during 
pre-clinical 
research,  clinical 
development  and 
trials, 
manufacturing and 
post-authorisation 
monitoring.  

guidance 
Such 
shall  comply  with 
EU 
relevant 
and 
legislation 
shall be developed 
and  updated 
in 
cooperation  with 
the Commission. 

The  European 
Medicines 
Agency  (‘the 
Agency’) 
shall  develop 
guidance  on 
the 
deployment 
and  use  of 
artificial-
intelligence 
systems 
(‘AI 
systems’)  and 
general-
of 
purpose  AI 
models  in  the 
lifecycle 
of 
medicinal 
products 
development, 
including 
during 
clinical 
research, 
clinical 
development 
and 
trials, 
manufacturing 
post-
and 
authorisation 
monitoring.  

pre-

Such 
guidance shall 
comply  with 
relevant  EU 
legislation 
and  shall  be 
developed and 
in 
updated 
cooperation 
with 
Commission. 

the 

Article [32]1 

A  project  located  Commission,  Data 

Data 

EN 

42 

  EN 

 
Biotechnology 
testing 
environments 
advanced 
biotechnology 
innovations   

for 

Article [33] 2a 

Biotechnology Data 
Quality Accelerator  

Article [33] 2b 

Biotechnology Data 
Quality Accelerator  

in  the  Union  that 
contributes  to  the 
development 
of 
testing 
trusted 
environments 
for 
AI-enabled 
biotechnology 
innovations 
shall 
be recognised as a 
high-impact health 
biotechnology 
strategic 
project 
where,  in  addition 
to  the  conditions 
in 
laid 
down 
[6], 
Article 
paragraph  [1], 
it 
substantially 
strengthens 
the 
Union’s  capacity 
for 
responsible 
experimentation, 
development, 
and 
testing 
validation  of  such 
innovations  and  it 
fulfils  all  of  the 
following 
conditions: 

aim  to  foster  the 
development  and 
of 
deployment 
and 
trustworthy 
AI 
competitive 
applications 
in 
health 
biotechnologies, 
including 
large-
scale  and  general-
purpose models; 

that 
are 

ensure 
datasets 
established, 
and 
managed 
processed 
in 
accordance  with 
applicable  Union 
legislation  on  data 
governance,  ethics 

Member  State 
authorities 

generation, 
Data 
processing, 
setting 
testing 
environments 
for AI 

up 

Research 
organisations, 
Biotechnology 
industry actors 

Development 
and  deployment 
of AI solutions 

Data 

Research 
organisations, 
Biotechnology 
industry actors 

Data 
generation,  data 
processing 

Data 

EN 

43 

  EN 

 
  
fundamental 
including 
(EU) 

and 
rights, 
Regulation 
2025/327 
[European  Health 
Space], 
Data 
Regulation 
(EU) 
2016/679 [General 
Protection 
Data 
Regulation].  

such 
the 
and 

make 
datasets,  or 
metadata 
reference 
annotations 
thereof,  available 
fair, 
under 
reasonable 
and 
non-
discriminatory 
conditions, 
ensuring  equitable 
access  for  users 
including  research 
organisations, 
SMEs  and  public 
institutions, 
in 
compliance  with 
the  provisions  of 
Article  [9]  of  this 
Regulation. 

contribute  to  the 
of 
development 
standards 
Union 
quality 
and 
for 
frameworks 
data 
representativeness, 
provenance, 
interoperability 
and  annotation  in 
biotechnology;  

where 
support, 
the 
appropriate, 
integration 
of 
these  datasets  into 
Union 
infrastructures, 

Article [33] 2c 

Biotechnology Data 
Quality Accelerator  

Article [33] 2d 

Biotechnology Data 
Quality Accelerator  

Article [33] 2e 

Biotechnology Data 
Quality Accelerator  

Data access 

Data 

Research 
organisations, 
Biotechnology 
industry actors 

Research 
organisations, 
Biotechnology 
industry actors 

Data 
interoperability, 
Standard 
Development 

Data 

Research 
organisations, 
Biotechnology 
industry actors 

Infrastructure 
interoperability, 
Data integration 

Data 

EN 

44 

  EN 

 
Article [33] 2f 

Biotechnology Data 
Quality Accelerator   

Article [35] 1 

Union  Regulatory 
Status Repository 

including 
the 
European  Health 
Data 
Space, 
European 
Area 
Research 
spaces,  or 
data 
other, 
including 
the  infrastructures 
operated  by  high 
impact 
health 
biotechnology 
strategic projects. 

due 
to 

give 
consideration 
the 
interoperability 
with 
platforms 
deployed  pursuant 
to  the  EHDS  and 
other relevant data 
spaces. 

The  Commission 
shall 
compile, 
maintain,  develop 
and make publicly 
available 
a 
Regulatory  Status 
Repository 
to 
assist  developers 
in 
navigating 
cases  of  novel 
biotechnology 
products 
(‘Regulatory 
Status 
Repository’). 

Research 
organisations, 
Biotechnology 
industry actors 

Platform 
interoperability 

Data 

Member  State 
authorities, 
Commission 

Technical 
documentation, 
Information 
exchange 

Data 

Data 

Technical 
documentation, 
Information 
exchange 

Article [35] 2 

Union  Regulatory 
Status Repository 

The 
Regulatory 
Status  Repository 
shall contain: 

Member  State 
authorities, 
Commission 

decisions, 

a) 
opinions, 
scientific 
recommendations 
regarding 
the 
status 
regulatory 
health 
of 
innovations, 

a 

EN 

45 

  EN 

 
(EU) 

issued  pursuant  to 
the  mechanisms 
in 
down 
laid 
Article 
of 
4 
[revised 
Regulation 
2017/745], 
Articles 61 and 62 
[revised 
of 
Regulation 
(EC) 
No  726/2004]  and 
Articles 13 and 69 
Regulation 
of 
(EU) 2024/1938; 

b)  the  summaries 
the  scientific 
of 
recommendations 
delivered  by 
the 
European 
Medicines Agency 
in accordance with 
Article 
of 
(EC) 
Regulation 
No  1394/2007  on 
whether  a  product 
falls  within 
the 
definition  of  an 
advanced 
therapy 
medicinal  product 
or not; 

17 

c)  the  discussion 
papers  delivered 
by  the  Foresight 
for 
Panel 
Emerging  Health 
Innovation. 

States 
Member 
shall 
make 
publicly  available, 
the 
through 
relevant  national 
platforms 
or 
registries, 
decisions, 
opinions, 
scientific 
recommendations, 
and  other  outputs 
issued  at  national 

Article [35] 3 

Union  Regulatory 
Status Repository 

Member  State 
authorities, 
Commission 

Technical 
documentation, 
Information 
exchange 

Data 

EN 

46 

  EN 

 
Member  State 
authorities, 
Commission 

Technical 
documentation, 
Information 
exchange 

Data,  Digital 
public service 

[39] 

Article 
Regulatory 
Sandboxes provided 
for 
the 
in 
applicable 
and 
frameworks 
Cross  Framework 
Communication 

concerning 
level 
regulatory 
the 
status  of  novel 
biotechnology 
products.  Member 
States shall inform 
the  Commission 
such 
where 
is 
information 
made available. 

European 

The 
Medicines 
Agency, 
the 
MDCG,  the  SCB 
and  the  Foresight 
as 
Panel, 
applicable, 
shall 
facilitate  dialogue 
the 
among 
authorities 
responsible for the 
setting  up  and  the 
implementation  of 
regulatory 
sandboxes 
novel 
biotechnology 
products. 
dialogue 
focus 
exchanging 
mutual 
and 
specifically 
including: 

learnings 
findings, 

This 
shall 
on 

for 
health 

promoting 

by 
the 
of 

and 
practices, 
on 

(a) 
knowledge 
sharing, 
facilitating 
exchange 
information, 
experiences 
best 
including 
regulatory 
approaches, 
technological 
challenges 

EN 

47 

  EN 

 
Article [40] 

Regulatory 
sandboxes for novel 
health 
biotechnology 
products  not  falling 
other 
under 
sandboxes in Union 
legislation   

Article [41] d 

EU Biothreat Radar 
High 
Impact 
Projects  

Commission 

Technical 
documentation 

Digital  public 
service 

lay  down 

The  Commission 
may,  by  means  of 
implementing 
acts, 
common 
principles,  criteria 
practical 
and 
arrangements 
for 
the  assessment  of 
applications 
received 
from 
developers and for 
the  establishment 
and 
the 
supervision  of  the 
regulatory 
sandboxes  and  for 
sandbox plans. 

Surveillance, 
data sharing 

Data 

Commission, 
Member  State 
authorities, 
Biotechnology 
industry 
actors, 
Research 
Organisations 

by 

that 
ensure 
sequencing 
data 
generated  through 
detection 
early 
activities is  shared 
in a timely manner 
via  the  European 
Nucleotide 
Archive (ENA), to 
enable  access  and 
use 
actors 
across  the  Union 
for 
the 
development, 
validation 
deployment 
advanced 
pathogen detection 
and 
characterisation 
methods;  engage 
partnerships 
in 
among 
industry, 
academia,  public 
authorities 
and 
defence  actors  to 
data 
ensure 
and 
sharing 
integration 
of 
warning systems; 

and 
of 

EN 

48 

  EN 

 
  
Article [42] f 

Biodefence 
capability 
impact 
project   

high 
strategic 

Article 
Verification 
Legitimate Need 

[44] 
of 

Article 
Prevention 
Reporting of Misuse   

[46] 
and 

development, 
and 
validation 
benchmarking  of 
the 
methods  for 
and 
detection 
attribution 
of 
genetic 
engineering, 
the 
including 
creation  of  open 
genetic 
engineering 
detection tools 

economic 
An 
that 
operator 
available 
makes 
on 
the  Union 
market,  including 
through 
online 
marketplaces, 
biotechnology 
of 
products 
concern,  shall,  for 
each 
transaction, 
verify  proof  of 
identity  of 
the 
prospective 
record 
customer, 
transaction, 
the 
including 
the 
quantities  ordered, 
assess 
and 
whether 
the 
customer  has  a 
legitimate need. 

For the purpose of 
preventing 
and 
detecting 
biotechnology 
misuse,  economic 
operators 
and 
online 
marketplaces  shall 

Commission, 
Member  State 
authorities 

cross 

Health 
border 
Surveillance, 
data sharing 

Data 

Economic 
operator, 
prospective 
customer 

Identity 
verification 

Data 

Economic 
operators, 
Online 
marketplaces 

Data  reporting, 
Information 
exchange 

Data  

EN 

49 

  EN 

 
  
  
Article [48] 2 

National  Inspection 
Authorities 

Article [48] 4 

National  Inspection 
Authorities 

Article [49] 

Commission 
Enforcement 
Support 
Monitoring 

and 

report  suspicious 
transactions,  

Member 
States 
shall  ensure  that 
national 
the 
inspection 
authority  has  the 
and 
resources 
investigative 
powers  necessary 
their 
to  perform 
including 
tasks, 
the 
to 
request 
information 
and 
records,  to  carry 
on-site 
out 
inspections 
and, 
where appropriate, 
to  conduct 
test 
purchases, 
including online. 

power 

States 
Member 
the 
shall  ensure 
participation 
of 
national inspection 
authorities, 
as 
appropriate,  in  the 
relevant  activities 
the  Steering 
of 
Group, 
in 
particular  for  the 
of 
exchange 
information 
on 
implementation 
practices, 
inspection 
findings 
emerging risks. 

and 

The  Commission 
may  support  and 
monitor  national 
competent 
authorities  in  the 
enforcement 
of 
section,  by 
this 
taking 
actions 
such  as  requesting 

Commission, 
Member  State 
authorities 

Information 
exchange 

Data  

Commission, 
Member  State 
authorities 

Information 
exchange 

Data 
flow) 

(data 

Commission  Monitoring, 

requesting 
information 

Data,  Digital 
public service 

EN 

50 

  EN 

 
  
Commission, 
Member  State 
authorities, 
Actors  in  the 
supply chain 

Monitoring, 
access  to  data, 
Technical 
guidelines 

Data,  Digital 
public service 

Commission, 
Member  State 
authorities 

Monitoring 
systemic risk 

Data 

Article [52]  

Advisory  Group  on 
Biosecurity   

Article [53] 

Biological  Systemic 
Risk  

information 
records 
running 
exercises. 

and 
and 
training 

in 

AI  models 
biological 
applications.  The 
Commission, 
based  on  advice 
the  Advisory 
by 
Group 
on 
and 
Biosecurity, 
where appropriate, 
in 
cooperation 
with  the  Steering 
Group,  may  issue 
and 
regularly 
update  guidance, 
to  assist  actors  in 
the  supply  chain 
and  the  competent 
authorities,  and  to 
facilitate 
cooperation 
between them. 

The  Commission 
shall 
monitor 
systemic risk from 
in 
AI  models 
biological 
applications 
and 
propose mitigating 
actions,  based  on 
advice 
provided 
by  the  Scientific 
including 
Panel, 
boosting 
biodefense 
capabilities 
regulation, 
on 
including 
and 
assessment 
mitigation 
of 
systemic risk from 
those  models,  as 
appropriate. 

or 

Article [54]  

information 
on 
how  to  exchange 

Commission, 
Member  State 

Information 

Data 

EN 

51 

  EN 

 
Monitoring 
Guidance 

and 

Article [55] 
Coordination on 
Biosecurity and 
Biosafety 

Article [56] 
Amendments to 
Regulation (EC) No 
178/2002 (General 
Food Law): Article 
3 

Article [56] 
Amendments to 
Regulation (EC) No 
178/2002 (General 
Food Law): Article 
49a (3)General 
provisions on 
regulatory 
sandboxes 

relevant 
information 
between 
competent 
authorities, 
contact 
national 
points  and  among 
Member States; 

Steering 
The 
Group 
in 
cooperation  with 
the  Commission, 
facilitates 
coordination  and 
information 
on 
exchange 
emerging 
AI-
enabled bio-risks; 

‘regulatory 
sandbox’  means  a 
controlled 
environment 
where  participants 
can test innovative 
or 
products 
substances 
and 
related  processes 
as well as data and 
regulatory 
other 
requirements  at  a 
pre-market 
stage 
under  a  set  of 
defined  rules  and 
monitoring and for 
a limited period of 
time. 

to 

Regulatory 
sandboxes may be 
in 
established 
relation 
the 
following:  (a)  all 
stages 
the 
of 
production, 
and 
processing 
of 
distribution 
the 
food  with 
exception 
of 
novel  foods,  and 

authorities 

exchange 

Commission, 
Member  State 
authorities 

Information 
exchange, 
Technical 
Guidelines 

Data,  Digital 
Public Service 

Commission, 
Member  State 
authorities 

Technical 
documentation, 
Information 
Exchange 

Data 

Member 
States 

Technologies, 
Data 

Facilitating  the 
development, 
testing, 
validation 
technologies; 

and 
of 

Testing 
requirements 

data 

Testing 
alternative 
regulatory 
requirements 

EN 

52 

  EN 

 
  
(such  as  digital 
labelling 
instead 
of 
actual  labels  on 
food products).  

also  of  the  feed 
produced  for,  or 
fed 
food-
to 
producing 
animals;  (b)  food 
contact  materials, 
the 
with 
exception 
of 
recycled 
plastic 
materials; 
(c) 
other 
products, 
than 
and 
food 
containing 
feed, 
or  consisting  of 
genetically 
modified 
organisms 
as 
defined  in  Article 
2,  point  (2),  of 
Directive 
2001/18/EC, 
excluding 
organisms 
obtained  through 
the  techniques  of 
genetic 
modification 
listed  in  Annex  I 
B 
to  Directive 
2001/18/EC.  The 
making  available 
of products within 
a 
regulatory 
sandbox  shall  not 
regarded  as 
be 
placing  on 
the 
market. 

Regulatory 
sandboxes 
shall 
have the following 
objectives:  

(a)        facilitating 
the  development, 
and 
testing 
of 
validation 
technologies, 
products 
and 
substances  before 
obtain 
they 
or 
authorisation 

EN 

53 

  EN 

 
 
for 
approval 
the 
placing  on 
market,  where  so 
required  by  Union 
law;  

(b)       testing data 
requirements, 
including  the  type 
of 
design 
and 
studies 
required 
for  conducting  a 
and/or 
safety 
efficacy 
assessment; 

law 

testing 

(c) 
alternative 
regulatory 
requirements  and 
their 
appraising 
as 
performance 
regards 
the 
attainment  of  the 
objectives  of  the 
applicable  Union 
sectoral 
in 
comparison  to  the 
existing 
requirements; 
in 
the  areas  where 
law 
Union 
for  an 
provides 
or 
approval 
authorisation, 
as 
well as in the area 
food 
of 
information 
to 
consumers 

Commission, 
Member  State 
authorities 

Technical 
documentation, 
Information 
Exchange 

Data 

Article [56] 
Amendments to 
Regulation (EC) No 
178/2002 (General 
Food Law): Article 
3 

‘regulatory 
sandbox’  means  a 
controlled 
environment 
where  participants 
can test innovative 
or 
products 
substances 
and 
related  processes 
as well as data and 
other 
regulatory 
requirements  at  a 

EN 

54 

  EN 

 
Member 
States 

Technologies, 
Data 

Facilitating  the 
development, 
testing, 
validation 
technologies; 

and 
of 

Testing 
requirements 

data 

Testing 
alternative 
regulatory 
requirements 
(such  as  digital 
labelling 
instead 
of 
actual  labels  on 
food products).  

Article [56] 
Amendments to 
Regulation (EC) No 
178/2002 (General 
Food Law): Article 
49a (3)General 
provisions on 
regulatory 
sandboxes 

pre-market 
stage 
under  a  set  of 
defined  rules  and 
monitoring and for 
a limited period of 
time. 

to 

Regulatory 
sandboxes may be 
in 
established 
relation 
the 
following:  (a)  all 
the 
of 
stages 
production, 
and 
processing 
of 
distribution 
the 
food  with 
exception 
of 
novel  foods,  and 
also  of  the  feed 
produced  for,  or 
fed 
food-
to 
producing 
animals;  (b)  food 
contact  materials, 
the 
with 
of 
exception 
recycled 
plastic 
materials; 
(c) 
other 
products, 
and 
than 
food 
feed, 
containing 
or  consisting  of 
genetically 
modified 
organisms 
as 
defined  in  Article 
2,  point  (2),  of 
Directive 
2001/18/EC, 
excluding 
organisms 
obtained  through 
the  techniques  of 
genetic 
modification 
listed  in  Annex  I 
B 
to  Directive 
2001/18/EC.  The 
making  available 

EN 

55 

  EN 

 
 
of products within 
regulatory 
a 
sandbox  shall  not 
regarded  as 
be 
placing  on 
the 
market. 

Regulatory 
sandboxes 
shall 
have the following 
objectives:  

(a)        facilitating 
the  development, 
and 
testing 
validation 
of 
technologies, 
and 
products 
substances  before 
obtain 
they 
or 
authorisation 
for 
approval 
placing  on 
the 
market,  where  so 
required  by  Union 
law;  

(b)       testing data 
requirements, 
including  the  type 
and 
of 
design 
studies 
required 
for  conducting  a 
safety 
and/or 
efficacy 
assessment; 

testing 

(c) 
alternative 
regulatory 
requirements  and 
their 
appraising 
as 
performance 
the 
regards 
attainment  of  the 
objectives  of  the 
applicable  Union 
in 
sectoral 
comparison  to  the 
existing 
in 
requirements; 
the  areas  where 
law 
Union 

law 

EN 

56 

  EN 

 
for  an 
provides 
or 
approval 
authorisation, 
as 
well as in the area 
food 
of 
to 
information 
consumers 

States 
Member 
shall  monitor  and 
the 
supervise 
operation 
of 
regulatory 
sandboxes 
that 
they  establish  and 
ensure 
compliance  with 
the 
regulatory 
sandbox plan. 

[56] 
Article 
Amendments 
to 
Regulation (EC) No 
178/2002  (General 
Food  Law):  Article 
49a 

General  provisions 
regulatory 
on 
sandboxes 

Member 
States, 
Commission 

Data 

Monitoring  and 
Supervision, 
Information 
exchange 

if 

the 

shall 

to 
established 

A  participant 
an 
regulatory 
sandbox 
immediately 
inform 
competent 
authorities  of  the 
Member  State(s) 
concerned 
it 
considers  or  has 
reason  to  believe 
that the conditions 
of  the  regulatory 
sandbox plan have 
not been complied 
with  and/or  there 
are  potential  risks 
to  public  health, 
animal  health  or 
welfare, 
plant 
health  or  to  the 
environment, 
may 
which 
require 
the 
revocation  of  the 
regulatory 
sandbox  or 
the 
amendment  of  the 
regulatory 
sandbox  plan 

to 

EN 

57 

  EN 

 
for 

provide 
mitigating 
measures. 
Participants  shall 
immediately 
also 
the 
inform 
competent 
authorities  of  any 
other  information 
that  concerns  the 
quality,  safety  or 
efficacy  of 
the 
subject  matter  of 
the 
relevant 
regulatory 
sandbox. 

to 

Member 
States 
shall  immediately 
notify 
the 
Commission  and, 
where  relevant,  to 
the  Authority  any 
the 
violation  of 
conditions  set  out 
in  the  regulatory 
plan 
sandbox 
the 
and/or 
identification 
of 
any potential risks 
to  public  health, 
animal  health  or 
welfare, 
plant 
health  or  to  the 
environment. 

Member 
States 
shall  suspend  or 
a 
revoke 
regulatory 
sandbox  at  any 
time  on  their  own 
motion,  or  at  the 
the 
request 
of 
Commission 
in 
accordance  with 
in 
paragraph  9, 
either 
the 
cases: 
following 
the 
(a) 
requirements  and 
conditions 

of 

EN 

58 

  EN 

 
the 

governing 
regulatory 
sandbox  plan  are 
not met; (b) where 
necessary 
to 
public 
protect 
health, 
animal 
health  or  welfare, 
plant  health  or  the 
environment  and 
no 
there 
is 
possibility 
for 
effective 
mitigation 
measures.  

States 
Member 
the 
shall 
inform 
Commission, 
the 
Authority  and  the 
Member 
other 
without 
States 
the 
delay 
of 
or 
suspension 
revocation  of  a 
regulatory 
sandbox and of the 
reasons. 

in 

Where  after 
the 
setting  up  of  a 
regulatory 
their 
sandbox 
a 
territory, 
Member 
State 
identifies  risks  to 
public 
health, 
animal  health  and 
plant 
welfare, 
health  and  to  the 
environment 
which can be fully 
by 
mitigated 
amendments to the 
regulatory 
sandbox  plan, 
it 
shall communicate 
the 
to 
Commission, 
the 
Authority  and  the 
other 
Member 
States  the    draft 

EN 

59 

  EN 

 
amendments 
in 
accordance  with 
the  procedure  laid 
down 
in  Article 
49b.  

the 

the 

Where 
Commission 
considers  that  one 
cases 
of 
in 
referred 
to 
paragraph  7 
is 
it  shall 
fulfilled, 
immediately  adopt 
implementing 
acts.in  accordance 
with the procedure 
referred 
in 
58(2) 
Article 
requesting 
the 
suspension  or  the 
revocation  of  the 
regulatory 
sandbox 
concerned.  

to 

in 
However, 
the 
emergencies, 
Commission  may 
provisionally 
adopt 
an 
implementing  act 
requesting 
the 
suspension  of  the 
regulatory 
sandbox 
after 
concerned 
consulting 
the 
Member  State(s) 
and 
concerned 
informing 
the 
other 
Member 
States.  As  soon  as 
possible,  and  at 
most  within  10 
working  days,  the 
taken 
measure 
shall 
be 
confirmed, 
or 
amended 
revoked 
in 
accordance  with 

EN 

60 

  EN 

 
to 

procedure 
the 
in 
referred 
Article  58(2)  and 
the reasons for the 
Commission’s 
decision  shall  be 
made 
public 
without delay.  

for 

A  Member  State 
may  prolong  the 
duration  once  of  a 
regulatory 
sandbox 
a 
limited time where 
this  is  justified  by 
the  need  to  attain 
the  objective  of 
the 
specific 
regulatory 
sandbox  at  hand 
and  shall  inform 
the  Commission, 
the  Authority  and 
the  other  Member 
States thereof.  

The Commission 
may, by means of 
implementing 
acts, specify 
common 
principles or  
practical 
arrangements for 
the establishment 
and supervision of 
regulatory 
sandboxes, 
including the 
establishment of 
sandboxes 
involving several 
Member States 
pursuant to this 
Article, Article 
49b and  49c 
.Those 
implementing acts 
shall be adopted in 
accordance with 
the procedure 

EN 

61 

  EN 

 
Commission, 
EFSA, 
Member  State 
authorities 

Information 
exchange 

Data 

Commission, 
Agency 
(EFSA), 
Member  State 
authorities 

Monitoring, 
Information 
exchange 

Data 

[56] 
Article 
Amendments 
to 
Regulation (EC) No 
178/2002  (General 
Food  Law):  Article 
49b 

Establishment 
regulatory 
sandboxes 
national level 

of 

at 

[56] 
Article 
Amendments 
to 
Regulation (EC) No 
178/2002  (General 
Food  Law):  Article 
49c 

and 

Other 
responsibilities, 
monitoring 
reporting 
obligations 
regarding 
regulatory 
sandboxes 

referred to in 
Article 58(2).  

Where a Member 
State deems it 
appropriate to 
establish a 
regulatory 
sandbox pursuant 
to Article 49a, it 
shall communicate 
to the 
Commission, the 
Authority and the 
other Member 
States a draft 
regulatory 
sandbox plan 60 
days prior to the 
commencement  

Regulatory 
sandboxes shall 
not affect the 
enforcement and 
monitoring 
responsibilities of 
the competent 
authorities set out 
in Article 17 and in 
other sectoral 
legislation. 
Participants, with 
the exception of 
final consumers, in 
particular the 
operator that is the 
developer of the 
product or 
substance 
concerned, shall 
remain liable under 
applicable national 
legislation for any 
harm inflicted on 
third parties as a 
result from the 

EN 

62 

  EN 

 
  
  
testing taking place 
in the sandbox. 

Member States 
shall submit annual 
reports to the 
Commission on the 
results from the 
implementation of 
regulatory 
sandboxes, 
including good 
practices 
developed, lessons 
learnt and 
recommendations 
on their setup and, 
where relevant, on 
the application of 
the relevant 
sectorial Union 
legislation. Those 
reports shall be 
made publicly 
available by the 
Commission.  

The Authority 
shall also ensure 
the necessary 
revisions of its 
guidance where 
relevant and 
appropriate on the 
basis of those 
annual reports. 

5: 
Article 
Submission  of  an 
application 
through EU portal  
6: 
Article 
Assessment  report 
by 
the  reporting 
Member  State— 
Aspects 
covered 
by Part I  
7: 
Article 
Assessment  report 

[58] 
Article 
Amendments 
to 
Regulation (EU) No 
536/2014  (‘Clinical 
Trials Regulation’) 

Biotechnology 
industry 
actors, 
Commission, 
Agency,  
Member 
States 

Submission  of 
an  application, 
Information 
exchange, 
access 
application 

to 

Data,  Process 
automation, 
EU portal 

EN 

63 

  EN 

 
  
  
14c: 

-  Aspects  covered 
by Part II 
8: 
Article 
the 
Decision  on 
trial  by 
clinical 
Member  States  to 
sponsor  
Article  9:  Persons 
the 
assessing 
application 
Article 
Coordinated 
assessment  for  the 
authorisation 
of 
combined studies  
Article 
17: 
Validation  of  an 
application  for  the 
authorisation  of  a 
substantial 
modification of an 
aspect  covered  by 
Part 
the 
I  of 
assessment report 
19: 
Article 
the 
Decision  on 
substantial 
modification of an 
aspect  covered  by 
Part 
the 
I  of 
assessment report 
20: 
Article 
validation, 
assessment 
and 
decision  regarding 
substantial 
a 
modification of an 
aspect  covered  by 
the 
II  of 
Part 
assessment report 
Article 
21: 
Substantial 
modification 
of 
aspects covered by 
Parts  I  and  II  of 
assessment 
the 
report 

EN 

64 

  EN 

 
Article  25:  Data 
the 
submitted 
application dossier  

in 

Evaluation 
AI models 

of 

Data 

[58] 
Article 
Amendments 
to 
Regulation (EU) No 
536/2014  (‘Clinical 
Trials 
Regulation’)/Article 
27e:  Use  of  AI  in 
Clinical Trials 

shall 
Sponsors 
AI 
evaluate 
or  AI 
models 
systems  proposed 
to  be  used  in  the 
the 
context 
of 
the 
lifecycle  of 
specific 
clinical 
trial 

Biotechnology 
industry 
actors, 
Commission, 
Agency,  
Member 
States 

Reporting 

Data, 
portal 

EU 

Biotechnology 
industry 
actors, 
Commission, 
Agency,  
Member 
States 

[58] 
Article 
Amendments 
to 
Regulation (EU) No 
536/2014  (‘Clinical 
Trials  Regulation’) 
Articles 41 –46, 55, 
79a 
56-58, 
regarding reporting 
requirements 

by 

42: 
of 

adverse 
the 
the 

41: 
Article 
Reporting 
of 
adverse events and 
adverse 
serious 
events 
the 
investigator  to  the 
sponsor 
Article 
Reporting 
suspected 
unexpected 
serious 
reactions  by 
to 
sponsor 
Agency 
Article 43: Annual 
the 
reporting  by 
the 
to 
sponsor 
Agency 
Article 
Assessment 
Member States 
46: 
Article 
with 
Reporting 
regard to  auxiliary 
medicinal 
products 
Article 
Monitoring 
Article 
Reporting 
serious breaches 

52: 
of 

44: 
by 

48: 

EN 

65 

  EN 

 
    
  
  
  
55: 

56: 

Article 
Investigator’s 
brochure 
Article 
Recording, 
processing, 
handling 
and 
storage  of  clinical 
trial information: 
Article 
Clinical 
master file 
Article 
58: 
Archiving  of  the 
trial 
clinical 
master file 

57: 
trial 

79a: 
Article 
as 
Obligations 
regards 
Union 
controls:  Ensure 
that  the  necessary 
technical 
assistance  and  the 
available 
documentation, 
upon 
justified 
request,  is  being 
provided 
the 
to 
as 
Commission 
well  as  any  other 
support 
the 
that 
Commission 
requests 

81 

is 
The 
shall 

Article 
amended: 
sponsor 
permanently 
update  in  the  EU 
database 
information 
on 
any changes to the 
trials 
clinical 
which 
not 
substantial 
modifications  but 
are relevant for the 

are 

[58] 
Article 
Amendments 
to 
Regulation (EU) No 
536/2014  (‘Clinical 
Trials Regulation’) 

Reporting 

Commission, 
Agency 
(EMA),  
Member 
States 

Data,  digital 
solution, 
process 
automation, 
EU portal, EU 
database 

EN 

66 

  EN 

 
  
  
Data protection  Data 

Biotechnology 
industry 
actors, 
Commission, 
Agency,  
Member 
States 

[58] 
Article 
to 
Amendments 
Regulation (EU) No 
536/2014  (‘Clinical 
Trials Regulation’) 

supervision  of  the 
clinical  trial.  The 
sponsor  shall  also 
update 
the  EU 
portal  to  satisfy  a 
condition to which 
an 
authorisation 
decision  is  subject 
to. 

in 

Article  93:  Data 
protection: 
Sponsors 
shall 
comply 
with 
Regulation 
(EU) 
to 
2016/679 
process  personal 
including 
data, 
concerning 
data 
health, 
the 
public  interest  of 
health 
the 
the 
context 
entire  lifecycle  of 
trial, 
a 
the 
from 
preparation  of  the 
application  for  the 
of 
authorisation 
the clinical trial to 
the  end  of 
the 
archiving period 

clinical 

in 
of 

Information 
exchange 

Data 

Commission, 
Member  State 
authorities, 
Agency 

[59] 
Article 
to 
Amendments 
Regulation 
(EU) 
2019/6  (Veterinary 
Medicine  Products 
Regulation) 

Article  61 
(2). 
Where  a  variation 
as  referred  to  in 
(1) 
paragraph 
the 
affects 
summary 
of 
product 
characteristics, 
labelling 
package 
the 
authorisation 
holder shall record 
the  change  in  the 
product  database 
within  30  days 

or 
leaflet, 
marketing 

EN 

67 

  EN 

 
  
  
Commission, 
Member  State 
authorities 

Technical 
documentation, 
Information 
Exchange 

Data 

Member  State 
authorities, 
Commission 

Assessment  of 
innovations 

Data 

Article [59] 

to 
Amendments 
Regulation 
(EU) 
2019/6  (Veterinary 
Medicine  Products 
Regulation) 

Article 
[61] 
to 
Amendments 
Regulation (EC) No 
2024/1938  Article 
[39a] 3 

SoHO 
sandboxes 

regulatory 

after 
implementation.   

its 

IX 

136a 

‘CHAPTER 
REGULATORY 
SANDBOX 
Article 
Regulatory 
sandbox  5.After  a 
is 
sandbox 
established, 
the 
Agency shall: 

or 

and 
a)develop 
make 
publicly 
available  technical 
scientific 
and 
requirements 
for 
technologies, 
methods 
products 
developed  under 
the 
sandbox, 
taking due account 
of 
the  potential 
risks of thereof for 
human and animal 
the 
and 
health 
environment; 

to 

The 
regulatory 
sandbox  shall  aim 
to 
the 
allow 
assessment  of  the 
innovations 
referred 
in 
paragraph  1  in  a 
real-world 
environment under 
regulatory 
strict 
to 
supervision, 
ensure 
the 
that 
necessary 
evidence  and  data 
is  generated 
to 
demonstrate  their, 
safety 
quality, 
including 
effectiveness 
view 
distribution. 

in 
their 

of 

EN 

68 

  EN 

 
Data 

Member  State 
authorities, 
developers, 
independent 
experts 
researchers, 
representatives 
of  healthcare 
professionals 
and patients  

and 

access, 

Data 
information 
exchange, 
leveraging 
information 
published 
on 
the  EU  SoHO 
(art 
platform 
of 
74.3(b) 
Regulation 
(EU)2024/1938, 

Article 
[61] 
to 
Amendments 
Regulation (EC) No 
2024/1398  

Article [39a] 7a 

SoHO 
sandboxes 

regulatory 

request 
and 
information 
data  from  holders 
of  authorisations 
SoHO 
of 
preparations, 
developers  
independent 
experts 
researchers, 
representatives  of 
healthcare 
professionals  and 
patients  and  may 
engage  with  them 
preliminary 
in 
discussions; 

and 

Information 
exchange 

Data 

Commission, 
Member  State 
authorities, 
research 
organisations, 
biotechnology 
industry actors 

Commission, 
Member 
States 

Information 
exchange 

Data,  Digital 
solution 

Article 
Evaluation 

[63] 

The 
national 
authorities and the 
economic 
shall, 
operators 
request, 
upon 
provide 
the 
Commission  with 
relevant 
any 
information 
they 
have  and  that  the 
Commission  may 
need 
its 
for 
assessment 
pursuant 
paragraph 1 

in 

to 

Article [66] 

Handling 
Confidential 
Information 

of 

States 
Member 
the 
and 
Commission  shall 
ensure 
the 
protection of trade 
business 
and 
secrets  and  other 
sensitive, 
confidential 
classified 
information 
and 
obtained 
in 
processed 
application  of  this 
Regulation, 

and 

EN 

69 

  EN 

 
  
including 
recommendations 
to 
and  measures 
be 
in 
taken, 
accordance  with 
and 
Union 
relevant  national 
law. 

to 

or 

The  Commission 
and 
Member 
States shall ensure 
classified 
that 
information 
provided 
exchanged 
this 
pursuant 
Regulation  is  not 
downgraded 
or 
declassified 
without  the  prior 
written  consent  of 
the  originator 
in 
accordance  with 
relevant  Union  or 
national law. 

EN 

70 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2. 

Data 

High-level description of the data in scope 

Type of data  

Reference to the 
requirement(s) 

Standard and/or specification 
(if applicable) 

Data required for testing and 
validation of biotechnology 
products 

Article [3]1 Health 
Biotechnology 
Strategic Projects 

N.A. 

Article [4] 1 High 
Impact Health 
Biotechnology 
Strategic Projects 

[15] 

Article 
2e 
Networks  of  Health 
Biotechnology 
Clusters  

[5] 

Article 
Biotechnology 
Development 
Accelerator 

Article [30] Strategic 
Projects 
for 
Biosimilars  

[32]  

Article 
Biotechnology  
Testing Environments  
for 
advanced 
biotechnology 
innovations 

[33] 

Article 
2 
Biotechnology  Data 
Quality Accelerator  

Article [59] 

Amendments 
Regulation 
2019/6 
Medicine 
Regulation) 

to 
(EU) 
(Veterinary 
Products 

[61] 
Article 
to 
Amendments 
Regulation  (EC)  No 
Article 
2024/1938/ 
[39a] 
SoHO 
3 
regulatory sandboxes 

Article [49a] General 

71 

EN 

  EN 

 
N.A. 

N.A. 

N.A. 

N.A. 

N.A. 

One implementing 
Act/Delegated Act foreseen 

Sensitive information, 
biotechnology datasets 

Mapping of existing 
infrastructures 

Guidance on the use and 
deployment of AI 

Regulatory decisions, opinions, 
recommendations 

Personal health data, clinical 
data 

Cross-border surveillance of 
biological threats 

provisions 
on 
regulatory sandboxes 

Article [16] Access 
Principles and 
Security Safeguards 

Article [17] Strategic 
Mapping of the 
Union’s 
Biotechnology 
Ecosystem 

Article [31] 
Guidance on the 
deployment and use 
of systems based on 
advanced 
technologies 
including AI Systems 
in the Lifecycle of 
Medicinal Products 

Article [35] 1 Union 
Regulatory Status 
Repository 

Article [58] 
Amendments to 
Regulation (EU) No 
536/2014 (‘Clinical 
Trials Regulation’) 

Article [41]  

EU  Biothreat  Radar 
High Impact Projects 

Article [42]  

Biodefence  capability 
high  impact  strategic 
project   

Article [44] 
Verification of 
Legitimate Need 

Article [46] 
Prevention and 
Reporting of Misuse 

EN 

72 

  EN 

 
  
Article [48]  

National Inspection 
Authorities   

Article [49] 

Commission 
Enforcement  Support 
and Monitoring 

Article [52]  

Advisory Group on 
Biosecurity   

Article [53] 

Biological  Systemic 
Risk 

and 

Article [54]  

Monitoring 
Guidance 

Article [55] 
Coordination on 
Biosecurity and 
Biosafety 

Handling of confidential 
information 

Article [66] Handling 
of 
Confidential 
Information 

N.A. 

Alignment with the European Data Strategy  

Explanation of how the requirement(s) are aligned with the European Data Strategy 

EN 

73 

  EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
Article  [33]  Biotechnology  Data  Quality  Accelerator  High  Impact  Health  Biotechnology 
Strategic  Projects  will  ensure  that  datasets  are  established,  managed  and  processed  in 
accordance  with  applicable  Union  legislation  on  data  governance,  ethics  and  fundamental 
rights, including Regulation (EU) 2025/327 [European Health Data Space], Regulation (EU) 
2016/679 [General Data Protection Regulation]. 

Alignment with the once-only principle 

Explanation  of  how  the  once-only  principle  has  been  considered  and  how  the  possibility  to 
reuse existing data has been explored 

The legal provision allows for the reuse of data and evidence that has already been submitted 
for the purposes of a first registration.  

Explanation  of  how  newly  created  data  is  findable,  accessible,  interoperable  and  reusable, 
and meets high-quality standards 

Through Union  programmes and infrastructures, the Act  promotes fair, reasonable and non-
discriminatory  access  to  high-quality  data  resources  for  researchers,  SMEs  and  public 
institutions, thereby accelerating innovation while ensuring compliance with Union standards 
on data protection, ethics and security. 

Frequenc
y (if 
applicabl
e) 

N.A. 

Data flows  

High-level description of the data flows 

Type of data 

Reference(s) 
to the 
requirement(
s) 

Actors who 
provide the 
data 

Actors who 
receive the 
data 

Trigger for 
the data 
exchange 

Biotechnolo
gy industry 
actors, 
Research 
organization
s 

Member 
States, 
Commission, 
Agencies 
(EMA, 
EFSA) 

Testing and 
validation of 
innovations 

Data 
required 
for  testing  and 
validation 
of 
biotechnology 
products 

Article [3]1 
Health 
Biotechnology 
Strategic 
Projects 

Article [4] 1 
High Impact 
Health 
Biotechnology 
Strategic 
Projects 

[5] 
Article 
Biotechnology 
Development 
Accelerator 

Article 
[15] 
2e  Networks 

EN 

74 

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of 
Health 
Biotechnology 
Clusters  

[29] 

Article 
Strategic 
Projects 
Biosimilars  

for 

Article 
Article [32] 

[32 

Biotechnology 
testing 
environments 
for  advanced 
biotechnology 
innovations   

Article 
[33] 
Biotechnology 
Data  Quality 
Accelerator  

[56] 

Article 
Amendments 
to  Regulation 
(EC) 
No 
178/2002 
(General 
Food  Law): 
Article  [49a] 
General  

Article [59] 

Amendments 
to Regulation 
(EU) 2019/6 
(Veterinary 
Medicine 
Products 
Regulation) 

[61] 

Article 
Amendments 
to  Regulation 
(EC) 
No 
2024/1398/ 
Article  [39a] 
3 
SoHO 
regulatory 
sandboxes  
provisions  on 
regulatory 

EN 

75 

  EN 

 
Member 
States, 
Commission 

Biotechnolo
gy industry 
actors, 
Research 
organization
s 

Member 
States, 
Agency 
(EMA), 
Commission 

Biotechnolo
gy industry 
actors, 
Research 
organization
s 

Reuse of 
existing data 

sandboxes 

Article [11] 
Single Points 
of Contact 

Guidance on 
the use and 
deployment of 
AI 

Article [31] 
Guidance on 
the 
deployment 
and use of 
systems based 
on advanced 
technologies 
including AI, 
in the 
Lifecycle of 
Medicinal 
Products 

Regulatory 
decisions, 
opinions, 
recommendatio
ns 

Article [35] 1 
Union 
Regulatory 
Status 
Repository 

Member 
States, 
Agency 
(EMA), 
Commission 

Biotechnolo
gy industry 
actors, 
Research 
organization
s 

Personal health 
data, clinical 
data 

Biotechnolo
gy industry 
actors, 
Research 
organization
s 

Member 
States, 
Agency 
(EMA) 
Commission 

Article [58] 
Amendments 
to Regulation 
(EU) No 
536/2014 
(‘Clinical 
Trials 
Regulation’) 

permit-
granting 
process for 
strategic 
biotechnology 
projects and 
high impact 
biotechnology 
projects 

Guidance for 
biotechnology 
industry actors 
and research 
organizations 
on the 
deployment 
and use of AI 
systems and 
general 
purpose AI 
models in the 
lifecycle of 
medicinal 
product 
development 

Repository 
will assist 
developers in 
navigating 
cases of novel 
biotechnology 
health 
biotechnology 
products  

Submission of 
clinical trial 

Cross-border 
surveillance of 
biological 

Article [41]  

EU  Biothreat 

Biotechnolo
gy industry 
actors, 

Member 
States, 

Detection, 
characterisatio
n, 

EN 

76 

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identification, 
analysis and 
assessment of 
biological 
threats 

threats 

Radar  High 
Impact 
Projects 

Research 
organization
s 

Commission 

Article [42]  

Biodefence 
capability 
high 
strategic 
project   

impact 

Article [44] 
Verification of 
Legitimate 
Need 

Article [46] 
Prevention 
and Reporting 
of Misuse 

Article [48]  

National 
Inspection 
Authorities   

Article [49] 

Commission 
Enforcement 
Support  and 
Monitoring 

Article [52]  

Advisory 
Group on 
Biosecurity   

Article [53] 

Biological 
Systemic Risk 

Article [54]  

Monitoring 
and Guidance 

Article [55] 
Coordination 
on Biosecurity 
and Biosafety  

Handling of 

Article [66]  Member 

Biotechnolo

Information 

EN 

77 

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confidential 
information 

Handling of 
Confidential 
Information 

States, 
Commission 

gy industry 
actors, 
Research 
organization
s 

acquired in the 
course of 
regulation, 
trade and 
business 
secrets 

How is 
accessibil
ity 
catered 
for? 

How is 
reusabilit
y 
considere
d? 

Use of AI 
technolog
ies (if 
applicabl
e) 

Yes 

Responsib
le body 

Commissi
on, 
Member 
States 

4.3. 

Digital solutions 

High-level description of digital solutions 

Digital 
solution 

Reference(s
) to the 
requiremen
t(s) 

Main 
mandated 
functionalit
ies 

Developme
nt of trusted 
testing 
environmen
ts  
biotechnolo
gy 
innovations 

Biotechnol
ogy  testing 
environmen
ts 
for 
advanced 
biotechnolo
gy 
innovations   

Article [32] 
Biotechnolo
gy testing 
environment
s for 
advanced 
biotechnolog
y 
innovations  
- high-
impact 
biotechnolog
y strategic 
projects 

For  each  digital  solution,  explanation  of  how  the  digital  solution  complies  with  applicable 
digital policies and legislative enactments 

Digital  solution  #1:  Biotechnology  testing  Environments  for  advanced  biotechnology 
innovations 

Digital and/or 
sectorial policy 
(when these are 
applicable) 

AI Act 

Explanation on how it aligns 

Development and testing of AI 
enabled biotechnology solutions 
is in line with Article 51. It 
ensures that these systems fulfil 
the obligations set out in 

EN 

78 

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EU Cybersecurity 
framework 

eIDAS 

Articles 53-55 of the act. 

Article 10 “Access Principles 
and Security Safeguards”  
provides that health 
biotechnology strategic projects, 
high impact biotechnology 
strategic projects, and any other 
entities operating infrastructures, 
facilities and services established 
or supported in accordance with  
this Regulation shall ensure that 
access to and the operation of 
their infrastructures, facilities 
and services complies, where 
applicable, with Directive (EU) 
2022/2555 of the European 
Parliament and of the Council 
(NIS2 Directive), including the 
relevant cybersecurity risk-
management and reporting 
obligations. 

Individuals and organisations 
will use electronic identification 
in line with EU legislation. 

Single Digital 
Gateway and IMI 

N.A. 

Others 

4.4. 

Interoperability assessment 

High-level description of the digital public service(s) affected by the requirements 

Digital public 
service or 
category of 
digital public 
services 

Biotechnology 
Data Quality 
Accelerator 

Description 

Reference(s) to 
the 
requirement(s) 

Interoperable 
Europe Solution(s)  

(NOT 
APPLICABLE) 

Other 
interoperability 
solution(s)  

Biotechnology 
Data Quality 
Accelerator, 
aimed at 
improving data 

// 

Article [33] 
Biotechnology 
Data Quality 
Accelerator  

EN 

79 

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quality at 
source, 
enhancing 
interoperability 
and annotation, 
and fostering 
the creation, 
curation, 
maintenance 
and use of 
shared datasets 
for the 
development 
and refinement 
of AI systems 
and models in 
health 
biotechnology. 

Category of 
digital public 
services 
according to 
COFOG #1 

// 

EN 

80 

  EN 

 
 
 
 
 
 
 
Impact of the requirement(s) as per digital public service on cross-border interoperability 

Digital public service #1 Biotechnology Data Quality Accelerator 

Assessment 

Measure(s) 

Alignment with 
existing digital and 
sectorial policies  

Please list the 
applicable digital and 
sectorial policies 
identified 

Organisational 
measures for a smooth 
cross-border digital 
public services 
delivery 

Please list the 
governance measures 
foreseen 

Measures taken to 
ensure a shared 
understanding of the 
data 

Please list such 
measures 

Use of commonly 
agreed open technical 
specifications and 
standards 

Please list such 
measures 

The Biotechnology Data 
Quality Accelerator will 
operate in accordance with 
applicable Union legislation 
on data governance, ethics 
and fundamental rights, 
including Regulation (EU) 
2025/327 [European Health 
Data Space], Regulation 
(EU) 2016/679 [General 
Data Protection 
Regulation]. 

It  will 
support,  where 
appropriate,  the  integration 
of these datasets into Union 
infrastructures, 
including 
the  European  Health  Data 
Space,  European  Research 
Area  data  spaces,  or  other, 
including the infrastructures 
operated  by  high 
impact 
health 
biotechnology 
strategic projects. 

Datasets, or the metadata 
and reference annotations 
thereof, will be available 
under fair, reasonable and 
non-discriminatory 
conditions, ensuring 
equitable access for users 
including research 
organisations, SMEs and 
public institutions. 

the 
to 
of  Union 
quality 
data 

It  will  contribute 
development 
standards 
frameworks 
for 
representativeness, 
provenance,  interoperability 

and 

Potential remaining barriers (if 
applicable) 

N.A. 

N.A. 

N.A. 

N.A. 

EN 

81 

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annotation 

and 
biotechnology 

in 

EN 

82 

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4.5.  Measures to support digital implementation 

High-level description of measures supporting digital implementation 

Description of the 
measure 

Reference(s) to the 
requirement(s)  

Commission 
role  

Actors to be 
involved 

Expected 
timeline 

(if applicable) 

(if applicable) 

(if 
applicable) 

Commission 
will produce 
guidelines or 
will be 
involved in 
the 
production of 
guidelines 

Agency (EMA, 
EFSA), 
Advisory 
Groups 
composed of 
Member State 
Representatives  

Adopting guidelines   Article [4] High 

Impact Health 
Biotechnology 
Strategic Projects 

Article [14] 
Financial and 
technical support 

Article [15] 
Networks of Health 
Biotechnology 
Clusters 

Article [39] 
Regulatory 
Sandboxes provided 
for in the applicable 
frameworks and 
Cross Framework 
Communication 

Article [58] 
Amendments to 
Regulation (EU) No 
536/2014 (‘Clinical 
Trials Regulation’): 

•  Article 37: 
End of a 
clinical trial, 
temporary 
halt and early 
termination 
of a clinical 
trial and 
submission 
of the results 

•  Article 47: 

Compliance 
with the 
protocol and 
good clinical 

EN 

83 

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Member States, 
Biotechnology 
Industry actors, 
Research 
organizations 

Member States 

Commission 
will 
participate 
through the 
Steering 
Group 

Commission 
shall 
encourage 
setting up 
regulatory 
sandboxes for 
AI 
biotechnology 
solutions, 
Substances of 
Human 
Origin 

practice 
•  Article 63: 

Manufacturin
g and import 

•  Article 85: 
Clinical 
Trials 
Coordination 
and Advisory 
Group 

Designing policy 
implementation 
pilots  

Article [15] 
Networks of Health 
Biotechnology 
Clusters 

Sandboxing 

Article [39]  
Regulatory 
sandboxes provided 
for in the applicable 
frameworks and 
cross-framework 
communication 

Article [40] 
Regulatory 
sandboxes or novel 
health biotechnology 
products not falling 
under other 
sandboxes in Union 
legislation 

Article [58] 
Amendments to 
Regulation (EU) No 
536/2014 (‘Clinical 
Trials 
Regulation’)/Article 
85: Clinical Trials 
Coordination and 
Advisory Group 

Article [59] 
Amendments to 
Regulation (EU) 
2019/6 (Veterinary 
Medicine Products 
Regulation) Article 
136a: Regulatory 

EN 

84 

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sandbox 

Article [61] 
Amendment to 
Regulation (EU) 
2024/1938 
(SoHO)/Article 39a: 
SOHO regulatory 
sandboxes 

EN 

85 

  EN