# Support from National medicines Agencies for the development of innovative medicines at the National levels, Open access on EuroGCT website

Auxane Delage, Aurélie Mahalatchimy

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Auxane Delage, Aurélie Mahalatchimy. Support from National medicines Agencies for the development of innovative medicines at the National levels, Open access on EuroGCT website. 2026. hal-05497214

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Submitted on 6 Feb 2026

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Support from National medicines Agencies for the development of innovative medicines at the National levels

Auxane Delage & Aurélie Mahalatchimy
February 2026

Introduction

National Medicines Agency are usually the first contact point of medicine developers. In that context, National Medicines agencies have created a diverse set of National support schemes to facilitate the development of medicines through early interactions with medicine developers. These are available in most of the European Economic Area (EEA) and European Union (EU) Member States. These mechanisms complete the set of schemes and procedures established at the European Level and those involving several competent authorities. They enable early dialogue at the National level for innovative medicines for preparing Clinical trials and future marketing authorisation applications. Existing National mechanisms for early interaction are quite similar across the EU. However, the names of those available mechanisms can differ from country to country. Despite National differences on the availability and content of existing mechanisms, parallels can be drawn on the basis of their common characteristics where those mechanisms exist. Beyond their identification, we have divided the various procedures available in EEA countries into two categories in order to streamline and clarify them:

1. **Advice Category** : This category refers to advice given at the national level. It includes scientific and/or regulatory advice as well as other types of advice which are formalised and, in most cases, paid services. For scientific and/or regulatory advice, the procedures are generally built as the EMA's scientific advice procedure, even though some specificities or minor differences can exist.

2. **Meeting Category** : The meeting category includes three different types of meetings: informal discussions, Portfolio meetings and Pre-submission meetings. These are mostly free of charge. The process is less formal, than the procedures in the advice category.

It is important to underline that each country has its specificities. Some offer many different schemes and services as they devote considerable effort to supporting and fostering the development of innovative medicines. Most countries have a procedure for scientific advice, and some have also one (or more) meetings' type procedure(s).

Developers can enter into early interaction with a National Medicines Agency, through the use of one or several of the schemes available in the targeted country. The choice of the scheme to enter should depend on the needs of developers, and on the budget they can allocate to these interactions with regulators.
(A. DELAGE, L.-S. GILBERT, J. VERAN, V. ROBY, A. MAHALATCHIMY, A comparative study of national schemes and services for "early interaction" with Regulators, ESGCT 2025, 7-10 October 2025, Sevilla, Spain.)

## Main actors

**Innovation office:** Innovation offices are a service provided by National medicines Agencies. They centralise the services and procedures available to developers of innovative health products (such as innovative medicines), including the ones designed to facilitate early interactions with regulators. Their aim is to help developers navigate the different support schemes that are available, and choose the right one according to their specific need. Innovation offices are a way of targeting and answering developers needs and to give them the support they need to bring new innovative medicines to the market. Examples of schemes and procedures for which innovation offices provide guidance are: the scientific advice procedure at the national level, or the simultaneous national scientific advice (SNSA) procedure, where available. It is important to underline that not all countries in the European Economic Area (EEA) have such a designated entity to assist developers in obtaining the information they need when creating a new medicine. The list of existing Innovation offices in the European Economic Area (EEA) countries is available on the EuroGCT Actors and Networks database.

**Medicines' developers:** Actors of the health sector finding new treatment options and bringing new medicines to the market, after authorisation. Medicine developers are the target of early interaction with regulators such as the European Medicines Agency (EMA). Medicines' developers can be academia industry, or non-profit organisations although they are generally from the industry sector (mainly big pharma but also SMEs) given the resources necessary for the commercialisation of medicines.

**National medicines Agencies:** At the national level, National medicines Agencies are the regulator in charge of promoting human health and ensuring the safety of medicines. They are the public body responsible for regulating medicines under the authority of the ministry of health in most countries. National medicines agencies evaluate, authorise, regulate and control human medicines as well as health in the realm of the State. A comprehensive list of National Competent Authorities in EU Member States can be found in EuroGCT's Actors and Networks database.

**Regulators:** Entities designated by law for authorisation, approval, evaluation, oversight, surveillance, and/or adoption of guidance in a specific field. In the context of gene and cell therapies, multiple regulators can be involved throughout their development cycle: medicines agencies (European or National), Health Technology Assessment bodies, research funding and authorisation authorities, patent offices, ethics bodies/committees, notified bodies (in the context of combination with medical devices), data authorities, etc. (From EuroGCT's Glossary of terms)

**Seeker of interaction:** The medicine developer interested in a specific procedure or service established to foster early interactions between Competent authorities and stakeholders. The purpose of the interaction is to facilitate the development of future marketable medicines.

## Definitions

**National Scientific Advice:** Scientific advice is always a formalised process as long as a specific procedure has to be followed in order to benefit from this type of early interaction. It includes a specific timeline, a specific scope of questions and of the advice to be given (regulatory and/or
scientific questions/advices), where applicable the type of product developed, and most of the time,
a fee. The fees can sometimes be waived, especially for academia and non-profit developers, or
SMEs.

The Scientific procedure can take different names depending on the country concerned. Scientific advice is not necessarily an early interaction: for example, scientific Advice can sometimes be given for a new indication of an already authorized medicine.

Practical steps

Note: Information, links and prices are accurate at the time of research in January 2026. New information and procedure were found between October 2025 and the end of January 2026 enabling a thinner analysis of data and adjustments to the results presented at the ESGCT Congress in October 2025. Also, the prices may change from what is announced. For instance, in the Netherlands, fees changed between 2025 and 2026, which explains the difference between the data in the Poster presented at ESGCT and those in this table below.

Abbreviations found in the following tables,

- : Information does not exist, or cannot be found for an existing procedure;
ATU: Temporary use authorisation (translated from the French "autorisation d'utilisation temporaire") ; DKTK: German Cancer Research Center ; DZIF: German Center for Infection Research ;
CTA : Clinical Trials Application; MA : Marketing Authorisation; ATMP : Advanced Therapy Medicinal Product

l. Advice procedures

1) Advice procedures in EU countries

Most EU countries have advice procedures. These include the following types:

- For medicines : Scientific advice, Classification of product (Ireland)

- For Medical devices (and combination products) : Consultancy and Digital applications (Germany).

Twenty-five advice procedures were identified in nineteen different EU countries, showing a wide variety of available advice procedures across the European Union.

Scientific advice (and its equivalent for medical devices) is the main type of advice procedure used in EU countries. Twenty different Scientific advice procedures have been identified at the time of research. Other types of advice procedures like Classification advice or Digital Health Applications (DiGA)/ Digital Care Applications (DiPA) consultations are country specific.

Advice procedures can be used for all types of medicines (meeting eligibility criteria), including ATMPs. Some countries (Norway, Spain) explicitly mention gene and cell therapy, highlighting the specific advantages that these interactions may offer for gene and cell therapy, and the particular attention the Agency may pay to these types of therapies. When nothing is explicitly specified, it does not mean that these procedures are not relevant to these therapies.

Table 1 below provides an overview of the advice procedures and their main elements that we have identified in EU countries.
<table><thead><tr><td>Country</td><td>Official Name</td><td>Who ? When ?</td><td>For what ? How ?</td><td>Fees</td></tr></thead><tbody><tr><td>Austria AT</td><td>National Scientific Advice (NASA)</td><td>For all developers<br/>During development (quality / pre-clinical / clinical etc.)</td><td>Submit application form with the questions to scientificadvice@basg.gv.at<br/>Validation of application<br/>4 working days<br/>Document of agreement with meeting date & cost<br/>Dossier deadline<br/>usually 3 weeks before meeting</td><td>7251 € – 11602 €</td></tr><tr><td>Belgium BE</td><td>Scientific-Technical Advice (STA) / SNSA</td><td>For all developers<br/>Before CTA/MA applications</td><td>Send Application form electronically to sta-wta@fagg-afmps.be<br/>Detailed guidance for National Scientific-Technical Advice (STA) requests<br/>R&D aspects in view of future CTAs, MA applications, variations, line extensions</td><td>200 € – 18000 €</td></tr><tr><td>Croatia HR</td><td>Scientific advice</td><td>For all developers<br/>Any time during development before MA/variation</td><td>Advice within 60 days (depends on complexity of request)</td><td>1500 € – 5200 €</td></tr><tr><td>Denmark DK</td><td>National scientific advice</td><td>For all developers<br/>Before CTA/MA; early phase project development</td><td>Request<br/>2–3 months before meeting;<br/>Acceptance of request<br/>Within 2 weeks;<br/>Briefing book<br/>2–3 weeks prior meeting;<br/>Written advice within 2 months</td><td>Payments (in DKK) apply as follows (including VAT):<br/>Clinical trial, FIH: 66,532.50 DKK<br/>Simple advice (Regulatory or CMC or Non-clinical): 40,855.00 DKK<br/>Partial multidisciplinary</td></tr></tbody></table>
<table><tr><td></td><td></td><td></td><td></td><td>- Clinical only; or<br/>- Clinical + CMC; or<br/>- Non-clinical.<br/>Regulatory included<br/>per default):<br/>68,822.50 DKK<br/><strong>Complete<br/>multidisciplinary</strong><br/>(All areas):<br/>87,157.50 DKK</td></tr><tr><td>Estonia EE</td><td>Scientific<br/>advice / Pre-<br/>submission<br/>consultation</td><td>For all<br/>developers<br/>Any stage of<br/>development</td><td><strong>Validation</strong><br/>within 2 weeks<br/><strong>Written advice</strong><br/>within 2 months of obtaining<br/>relevant<br/>documentation</td><td>6000 €</td></tr><tr><td>Finland FI</td><td>Scientific<br/>advice</td><td>For all<br/>developers<br/>Independent of<br/>MA process</td><td><strong>Presentation</strong><br/>no later than 1 week<br/>before meeting;<br/><strong>Minutes</strong><br/>within 2 weeks of the<br/>meeting</td><td>5600 €</td></tr><tr><td>France FR</td><td>Scientific<br/>advice</td><td>For all<br/>developers<br/>Any stage;<br/>especially if no<br/>EMA<br/>recommendatio<br/>ns or deviation</td><td>For any enquiries:<br/><u>innovation@ansm.sant<br/>e.fr</u></td><td>Free of charge<br/>(exception)</td></tr><tr><td>Germany DE</td><td>Scientific<br/>Advice with<br/>DKTK and DZIF</td><td></td><td>For project initiatives<br/>of the German Cancer<br/>Research Center<br/>(DKTK) and the<br/>German Center for<br/>Infection Research<br/>(DZIF)<br/><u>https://dktk.dkfz.de/en/<br/>about-us/about-dtk</u><br/>Innovation Office<br/><u>innovation@pei.de</u><br/>+49 6103 77 2772</td><td></td></tr><tr><td>Germany DE</td><td>DiGA advice<br/>(for medical<br/>device,<br/>including as<br/>linked to<br/>medicines)</td><td>—</td><td><strong>Meeting</strong><br/><strong>Introduction</strong><br/>≈ 5-10 min<br/><strong>Presentation by the<br/>applicant</strong><br/>≈ 15 - 20 min<br/><strong>Discussion of<br/>questions</strong></td><td>250 € - 5,000 €</td></tr></table>
<table><tr><td></td><td></td><td></td><td>≈30 - 60 min<br>Max. 90 minutes (standard 60 minutes + 30 minutes back-up)<br>Contact: innovation@bfarm.de +49 (0)228 99 307 4053</td><td></td></tr><tr><td rowspan="2">Germany DE</td><td rowspan="2">DiPA advice (for medical device including as linked to medicines)</td><td rowspan="2">—</td><td><strong>Meeting</strong></td><td rowspan="2">250 € - 5,000 €</td></tr><tr><td><strong>Introduction</strong><br>≈ 5-10 min<br><strong>Presentation by the applicant</strong><br>≈ 15 - 20 min<br><strong>Discussion of questions</strong><br>≈30 - 60 min<br>Max. 90 minutes (standard 60 minutes + 30 minutes back-up)<br>Contact: innovation@bfarm.de +49 (0)228 99 307 4053</td></tr><tr><td rowspan="2">Germany DE</td><td rowspan="2">Scientific Advice</td><td>For all developers</td><td>Product/ Project-specific;</td><td rowspan="2">1000 € - 18,000 €</td></tr><tr><td>Before CTA/MA</td><td><strong>Advice meetings</strong><br>usually take place within 3-6 months of the application<br><br><strong>Contact</strong><br><u>advice@bfarm.de</u><br>+49 (0) 228 99 307 - 3958</td></tr><tr><td rowspan="2">Germany DE</td><td rowspan="2">Scientific Advice</td><td rowspan="2">For all developers</td><td>On Therapy concept, Manufacturing process, Non-clinical development, Clinical development, National authorisation<br>In view of centralised marketing authorisation</td><td>Based on the complexity of the with <em>Special Fee Ordinance BMG - B MGBebV, Section 3, German Medicinal Products Act, Table 2, No. 20.1</em></td></tr><tr><td>Innovation Office<br><u>innovation@pei.de</u><br>+49 6103 77 2772</td><td>Amount of fees for consultation<br>200 € to 6,000 €</td></tr></table>
<table><tr><td>Hungary HU</td><td>Scientific advice/consultancy</td><td>—</td><td>All the steps on <u>How to apply for scientific advice</u><br/><u>Validation</u><br/>within 5 workdays;<br/><u>Written answers</u><br/>within 40 workdays;<br/><u>Oral meeting</u><br/>scheduled within 40 workdays (≤90 min);<br/><u>Minutes</u><br/>≤10 workdays<br/><u>Final minutes</u><br/>≤10 workdays</td><td>Fees</td></tr><tr><td>Ireland IE</td><td>Classification Procedure</td><td>—</td><td>Early classification for borderline products<br/>The scope includes tissues and cells<br/><u>To submit</u> query or request on classification: <u>classification@hpra.ie</u>.<br/>Full details of procedure in the <u>Guide to the Definition of a Human Medicine</u>.<br/>To complete, <u>Request document for classification of human health product</u></td><td>Guide to fees for human products</td></tr><tr><td>Ireland IE</td><td>Scientific advice</td><td>—</td><td><u>Guide for national scientific and regulatory advice</u><br/>Written and meeting procedure format<br/><u>To complete, Request document for national scientific and regulatory advice</u></td><td>Guide to fees for human products</td></tr><tr><td>Ireland IE</td><td>Swift Scientific advice</td><td>—</td><td><u>Guide for national scientific and regulatory advice</u><br/>Written procedure only</td><td>Guide to fees for human products</td></tr></table>
<table><tr><td>Latvia LV</td><td>Scientific advice</td><td>For all developers<br/>Any stage of initial development; pre-submission for renewal/variation; post-authorisation possible</td><td>Acceptance notification within 7 days<br/>Advice sent within 8 weeks after payment and complete documentation received</td><td>Regulatory: 2000 €<br/>Scientific: 7000 €</td></tr><tr><td>Lithuania LT</td><td>Scientific-regulatory advice</td><td>For all developers<br/>Development / authorisation / post-authorisation</td><td>Timeline and steps of the procedure described in the order of the Head of the Agency dated on 2 April 2024<br/>No.(1.72E)1A-412</td><td>3000 € – 4500 € – 7000 €</td></tr><tr><td>Netherlands NL</td><td>Scientific and regulatory advice (MEB)</td><td>For all developers<br/>Across product cycle (pre-clinical to post-marketing changes)</td><td>Timeslot decision for meeting within 3 weeks<br/>Written advice within 7 weeks of acceptance<br/>Oral meeting scheduled 6 weeks–3 months after acceptance<br/>Documents ≥3 weeks before meeting;<br/>Definitive advice within 4 weeks after meeting</td><td>Simple advice: 8 400 €<br/>Partial multi-disciplinary scientific advice: 14 370 €<br/>Complete multi-disciplinary advice: 19 170 €<br/>Customised advice: 2 840 €</td></tr><tr><td>Portugal PT</td><td>Regulatory and Scientific Advice (RSA)</td><td>—</td><td>Validation 10 days<br/>Convening of meeting No later than 30 days<br/>Advice 60 days<br/>Final advice and answer to company 10 days<br/>Applicant Payment of Fee, after validation 5 days<br/>Responses to requests 10 days<br/>Submission of meeting minutes 10 days<br/>Timeline and Steps of the procedure</td><td>Fees</td></tr></table>
<table><tr><td>Czechia CZ</td><td>Consultancy (for medical Devices) / Scientific Advice on marketing authorisation issues (for medicinal products)</td><td>For pharmaceutical company, for sponsor of clinical studies, for any entity marketing authorisation applicant<br>Early stages of device development (medical devices scope)<br>For pharmaceutical, pre-clinical, and clinical of medicinal product development</td><td>Written or Oral Scientific advice<br>Procedural-regulatory and scientific issues on requirements for pharmaceutical, pre-clinical, and clinical documentation and safety for medicinal products.<br>See link and application form for information on the steps and timeline of the procedure<br>Apply for Scientific advice<br>Link to ask for Consultancy</td><td>Instructions for payment of expenses and administrative charges – SÚKL</td></tr><tr><td>Slovakia SK</td><td>Scientific advice (SIDC)</td><td>For all developers<br>Initial development and/or post-authorisation phase</td><td>Company notes within 10 days after meeting;<br>Written answer within 30 days after meeting;<br>Final letter within 30 days of meeting</td><td>Simple scientific advice:<br>Quality development 2100 €; Non-clinical development 2100 €; Clinical development 2100 €; Safety development 2100 €; Legal status of medicinal product 1600 €<br>Partial scientific advice:<br>Quality and safety development 3000 €; Clinical and non-clinical development 3000 €; Safety and clinical development 3000 €<br>Multidisciplinary scientific advice:<br>Quality and (non)clinical and safety development 3700 €</td></tr></table>
<table><tr><td>Slovenia SI</td><td>Scientific advice (JAZMP)</td><td>For all developers<br/>When drafting/technical contents of MA or CTA;</td><td>For any medicinal product<br/>Article 29 of the Medicinal Products Act (Official Gazette of the RS, No 17/14 with amendments)<br/>Send requests to strokovno.svetovanje@jazmp.si<br/>Information on the possibility of expert advice given as soon as possible (no full timeline specified)</td><td>—</td></tr><tr><td>Spain ES</td><td>National Scientific/ Regulatory Advisory (Initial request / Follow-up counseling/ pre- submission meeting)</td><td>For all developers with incentives for non-commercial public entities<br/>When guidelines insufficient / deviation; Before RMS/ Rapporteur designated</td><td>ATMPs mentioned<br/>Send request to ascina@aemps.es<br/>Validation/ acceptance phase 10 days; Documents ≥30 days prior to meeting; Written report within 90 days (if written); TC/meeting max 1.5 hours; Minutes ≤15 days after meeting</td><td>Relación de los códigos e importes de las tasas | AEMPS<br/>Between 153,79 € and 6.738.76 € depending on the complexity and type of request<br/>ATMP fee exemption mentioned for non-commercial public entities</td></tr><tr><td>Sweden SE</td><td>Scientific advice</td><td>—</td><td>Any medical product<br/>Different forms of scientific advice<br/>Face-to-face meeting<br/>At the Swedish MPA premises. Maximum 6 participants present.<br/>Digital MS Teams meeting<br/>Maximum 12 participants.<br/>Hybrid meeting<br/>Maximum 6 participants present at the Swedish MPA premises and 6 participants via MS Teams.</td><td>SEK 65,000<br/>Fee reduction on a case-by-case basis<br/>Request must be justified by the developer<br/>If not granted the price is due in full</td></tr></table>
<table><caption>Table 1: Overview of Advice procedures in EU countries</caption><tr><td></td><td><strong>Written advice</strong><br>Swedish MPA will send the response within two months from receipt of relevant documentation.<br><br><strong>Docs submitted electronically</strong><br>≥3 weeks before meeting;<br><br><strong>Written advice within 2 months from receipt of documentation;</strong><br><br><strong>Meeting</strong><br>90 minutes;<br><br><strong>Minutes</strong><br>within 1 month;<br><br>No meetings<br>July/August<br><br>Application for<br><u>scientific advice</u> |<br>Swedish Medical<br>Products Agency</td></tr></table>

## More information on country- specific procedures

- Ireland's Classification procedure

At the time of research and based on the collected data, only Ireland appears to have a specific procedure in place to assist in the classification of medicinal products for human use.

The Irish Medicines Agency (HPRA) "offers a service to stakeholders to clarify the **appropriate regulatory category for products** that are borderline between human medicines, medical devices and other regulated products, such as cosmetics."

Follow this link for more information on this procedure.

- DiGA/DiPA consultations in Germany (for medical devices and combination products)

The German innovation office at the Federal Institute for Drugs and Medical Devices (BfArM) offers a specific pre-advice meeting (see below for more information on meeting procedures within the EU) and two types of advice procedures, called consultations. They are made for digital applications.

The two consultations are aimed at:

- Digital health apps that can be prescribed to patients to help them treat with their condition (DiGA),
- The healthcare applications designed to help healthcare providers manage patients and diseases (DiPA).

With the progress of new numerical technologies, new medical devices can be “apps on prescription”, they meet the definition and framework required to be authorised as medical devices and are part of the treatment of a disease.

Developers of such applications can ask for advice following the steps of the procedure below

<figure><img src="image_2.png" /></figure>

(From Pre-advice & DiGA-/DiPA-consultation by the Innovation Office at the Federal Institute for Drugs and Medical Devices (BfArM), p.8)

## 2) Advice procedures in non-EU EEA countries (Iceland, Norway, Lichtenstein)

Most non-EU EEA countries have established advice procedures. In fact, two out of three countries do so (Iceland & Norway). No information was found for Lichtenstein leading to the conclusion, there is no advice procedure in that country.

Please find below, in Table 2, the main elements gathered from the relevant websites for countries that have an advice procedure in place.

<table><thead><tr><td>Country</td><td>Official Name</td><td>Who ? When ?</td><td>For what ? How ?</td><td>Fees</td></tr></thead><tbody><tr><td>Iceland</td><td>Scientific advice (IMA)</td><td>For all developers<br/>Any stage of development</td><td>To request by application form to imascient ificadvice@ima.is<br/><br/>Answer<br/>Within 2 weeks from receipt;<br/><br/>Background documentation<br/>send no later than 3 weeks ahead of meeting<br/><br/>Written response<br/>within 2 months</td><td>Fees - Icelandic Medicines Agency<br/><br/>Hourly based fee<br/>ISK 22 800<br/><br/>See the TARIFF for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency.</td></tr></tbody></table>
<table><caption>(Table 2: Overview of Advice procedures in non-EU EEA countries)</caption><tr><td></td><td></td><td></td><td>from receipt of documentation;<br/><b>Minutes</b><br/>within 1 month<br/><br/>No advice meetings<br/>July/August;</td><td>See the <u>Rules on reduction of fees according to Tariff no. 1554/2023</u></td></tr><tr><td><b>Norway NO</b></td><td><u>Scientific and regulatory advice for the development of medical products (NoMA)</u></td><td>For all developers<br/>All phases of lifecycle (medicinal products and medical devices)</td><td>ATMP is an area of expertise<br/>Timeline not specified</td><td>—</td></tr></table>

## II. Meeting procedures

National medicines agencies in several EU countries have set up less formal procedures. These may be requested without an application form, except in the rare instances the procedure is part of an advice procedure (Sweden). They are designed to help developers ask questions about innovative medicines' development before seeking advice, or to avoid resorting to formal advice, such as scientific advice. Some countries (e.g., Spain or Sweden) do not distinguish between these procedures and requests for scientific advice (advice procedure). Other countries do distinguish between the two.

These types of procedures are usually free of charge. These specific ways of interacting with National regulators can be classified into three different categories, based on specific criteria that highlight similarities between different schemes in different countries:

1. **Informal discussion:** Some schemes are designed to enable developers to enter into early interaction with a National competent authority in order to obtain, in an informal setting (written or oral), answers to certain questions they may have. These meetings (or written answers) would not necessarily be preparatory to a request for Scientific advice, but would serve solely to answer certain questions on general regulatory or scientific requirements.

2. **Portfolio meeting:** Meeting for strategic planification.

3. **Pre-submission meeting:** Preparatory meeting for a request for Scientific advice.
<table><caption>(Table 3: Comparative overview of existing meetings procedures across EU countries)</caption><thead><tr><th>Country</th><th>Informal discussion</th><th>Pre-advice / Pre-submission meeting</th><th>Portfolio meeting</th></tr></thead><tbody><tr><td>Belgium<br>BE</td><td>☑ Project-info meetings</td><td>☑ Pre-submission meetings</td><td>☑ Portfolio meetings</td></tr><tr><td>Finland<br>FI</td><td>☑ Informal regulatory guidance</td><td>—</td><td>—</td></tr><tr><td>France<br>FR</td><td>—</td><td>☑ Pre-submission meeting</td><td>☑ Development portfolio presentation for strategic planification</td></tr><tr><td>Germany<br>DE</td><td>—</td><td>☑ Kick-off meetings (DKTK/DZIF);<br>☑ Pre-advice meetings (BfArM / PEI);<br>☑ Pre-submission meetings (centralised procedure)</td><td>☑ Portfolio meetings</td></tr><tr><td>Ireland<br>IE</td><td>☑ Innovation Office queries</td><td>☑ Pre-submission meeting</td><td>—</td></tr><tr><td>Malta<br>MT</td><td>☑ Informal meetings (Innovation support – MMA)</td><td>—</td><td>—</td></tr><tr><td>Spain<br>ES</td><td>—</td><td>☑ Pre-submission meetings</td><td>—</td></tr><tr><td>Sweden<br>SE</td><td>—</td><td>☑ Pre-submission meeting</td><td>—</td></tr></tbody></table>

Few countries have established meeting procedures; they are fifteen such procedures in seven different countries. Among these countries Italy and Malta do not have advice procedures, unlike the other countries which have established a meeting procedure. Therefore, most countries with a meeting procedure also provide one or more advice procedure.
Meeting procedures can be used for all types of medicines, including ATMPs. Some countries (Malta & Italy) explicitly mention gene and cell therapy, highlighting the specific advantages that these interactions may offer for gene and cell therapy, and the particular attention the Agency may pay to these types of therapies. When nothing is explicitly specified, it does not mean that these procedures are not relevant to these therapies.

Table 4 below provides an overview of the Meetings procedures and their main elements that we have identified in EU countries.
<table><thead><tr><th>Country</th><th>Official Name</th><th>Who ? When ?</th><th>For what ? How ?</th><th>Fees</th></tr></thead><tbody><tr><td>Belgium BE</td><td>Project-info meetings</td><td>For SMEs, academic research centres, spin-offs and academic hospitals<br>Very early-stage clinical research project</td><td>Granted depending on eligibility and expert availability (no fixed timeline stated)<br>On general regulatory requirements/procedural steps when initiating a medicine development project, to identify any future scientific, technical and regulatory hurdles</td><td>—</td></tr><tr><td>Belgium BE</td><td>Portfolio meetings</td><td>For all developers<br>Before engaging in formal scientific advice</td><td>Strategic pipeline discussion on company, activities, medicine development pipelines, therapeutic areas, the latest scientific developments and challenges<br>Request by written request to innovationoffice@fagg-afmps.be (timing by agreement)</td><td>—</td></tr><tr><td>Belgium BE</td><td>Pre-submission meetings</td><td>For all developers<br>Before MA/registration/va-riation submission</td><td>—</td><td>—</td></tr><tr><td>Finland FI</td><td>Informal Regulatory Guidance</td><td>For all developers<br>Early stage of development</td><td>On planned or implemented studies/reports<br><strong>Presentation</strong><br>No later than 1 week before meeting</td><td>—</td></tr></tbody></table>
<table><tr><td></td><td></td><td></td><td><b>Minutes</b><br>within 2 weeks</td><td></td></tr><tr><td></td><td></td><td></td><td><b>Comments</b><br>within 2 weeks (if needed)</td><td></td></tr><tr><td>France FR</td><td>Regulatory support (informal exchanges)</td><td>For all developers<br>Any stage (regulatory positioning/classification/qualification etc.)</td><td>Briefing book mandatory for certain requests ( timeline not specified)<br>For any enquiries: innovation@ans.m.sante.fr</td><td>—</td></tr><tr><td>France FR</td><td>Pre-submission meeting</td><td>For all developers<br>Before CT dossier / ATU / MA submission</td><td>For any enquiries: innovation@ans.m.sante.fr</td><td>—</td></tr><tr><td>France FR</td><td>Development portfolio presentation</td><td>For all developers</td><td>Strategic planning across development program<br>For any enquiries: innovation@ans.m.sante.fr</td><td>—</td></tr><tr><td>Germany DE</td><td>Kick-off meeting with DKTK and DZIF</td><td>Early stage of development</td><td>For project initiatives of the German Cancer Research Center (DKTK) and the German Center for Infection Research (DZIF)<br>On DKTK cooperation with regulatory agencies, https://dktk.dkfz.de/en/about-us/about-dtk<br>See, flyer on the collaboration between DKTK and PEI for early interaction<br>Innovation Office innovation@pei.de +49 6103 77 2772</td><td>Free of charge</td></tr></table>
<table><tr><td rowspan="2">Germany DE</td><td>Pre-Advice Meeting on digital applications</td><td>For all developers</td><td>Meeting within 3-6 months from application</td><td rowspan="2">Free of charge</td></tr><tr><td>ATMPs mentioned explicitly</td><td>Very early stage of development</td><td>Contact: innovation@bfarm.de +49 (0)228 99 307 4053</td></tr><tr><td rowspan="2">Germany DE</td><td>Pre-Submission Meeting (centralised procedure)</td><td>For all developers</td><td>Timing not specified (meeting prior to submission)</td><td rowspan="2">Free of charge</td></tr><tr><td></td><td>Prior to upcoming centralised MA application/ variation (EMA)</td><td>Contact advice@bfarm.de +49 (0) 228 99 307 - 3958</td></tr><tr><td rowspan="2">Germany DE</td><td>Portfolio Meeting</td><td>For all developers</td><td>Pipeline overview</td><td rowspan="2">Free of charge</td></tr><tr><td></td><td>Before CTA/MA</td><td>Timing not specified (by agreement)</td></tr><tr><td rowspan="2">Ireland IE</td><td>Innovation Office queries</td><td>For all developers</td><td>Contact advice@bfarm.de +49 (0) 228 99 307 - 3958</td><td rowspan="2">Free of charge</td></tr><tr><td></td><td>Any stage but especially in the early stages</td><td>Innovation Office Form Written answer to a question</td></tr><tr><td rowspan="3">Ireland IE</td><td rowspan="3">Pre-submission meeting</td><td rowspan="3">For all developers</td><td>Response within 20 working days; Respect of confidentiality</td><td rowspan="3">Free of charge</td></tr><tr><td>To discuss details of upcoming procedure including marketing authorisation, line extension, extension of indication applications</td></tr><tr><td>Request 3 months before the submission of application</td></tr><tr><td></td><td></td><td></td><td>Briefing Documents 30</td><td></td></tr></table>
<table><tr><td></td><td></td><td></td><td>days in advance of the meeting</td><td></td></tr><tr><td></td><td></td><td></td><td><strong>Meetings</strong><br>90 minutes</td><td></td></tr><tr><td></td><td></td><td></td><td>No application form</td><td></td></tr><tr><td></td><td></td><td></td><td>Send request to cap@hpra.ie</td><td></td></tr><tr><td rowspan="2">Italy IT</td><td>Innovation meeting</td><td>For all developers</td><td>Advanced therapies mentioned</td><td>—</td></tr><tr><td></td><td>Early development of innovative products/technologies</td><td></td><td></td></tr><tr><td rowspan="2">Malta MT</td><td>Informal meetings</td><td>For all developers</td><td>for novel products/methodologies, Stem cells listed as interest area</td><td>—</td></tr><tr><td></td><td>Early dialogue</td><td>Timeline not specified, scheduled via email</td><td></td></tr><tr><td rowspan="5">Sweden SE</td><td>Pre-submission meeting</td><td>For all developers</td><td>Any medical product</td><td>Free of charge</td></tr><tr><td></td><td></td><td>Pre-submission meeting possible if MPA is appointed rapporteur/co-rapporteur</td><td></td></tr><tr><td></td><td></td><td><strong>Pre-submission meeting</strong><br>Possible request if the agency is appointed rapporteur or co-rapporteur. A pre-submission meeting is an opportunity to present your products and to discuss regulatory matters. No scientific questions.</td><td></td></tr><tr><td></td><td></td><td>The same application form as for scientific</td><td></td></tr><tr><td></td><td></td><td></td><td></td></tr></table>
<table><caption>(Table 4 : Overview of Meetings procedures in EU countries)</caption><tr><td></td><td></td><td>advice should be used for pre-submission meetings.<br/><strong>Meeting</strong><br/>90 minutes;<br/><strong>Minutes</strong><br/>within 1 month;<br/>No meetings in July/August<br/><u>Application for scientific advice | Swedish Medical Products Agency</u></td><td></td></tr></table>

For the other countries, namely Bulgaria, Cyprus, Greece, Luxembourg, Poland, Romania and Liechtenstein, no information was found. It seems likely there are no established procedures in these countries, or at least none has been found.

## Challenges

* Because of a lack of harmonisation, the services and procedures or types of advice available vary from country to country. The procedure that developers require may not be available in their country.

* The vocabulary used by Competent authorities may differ from country to country. Even if the schemes are similar, they may not have the same exact name.

* Finding the information on the existing schemes is also a challenge in itself. Some information is clearly stated on websites, but in other countries, contradictory information or outdated information may be found. The multiplicity of webpages can make searching for early interactions more difficult. The tables provided here will therefore facilitate access to information, particularly for developers seeking comparative information on opportunities for interaction with regulators at national level in several EEA countries.

* The language barrier could also be a challenge when trying to get information on several EEA countries. However, there appears to be a genuine effort to provide information in English as well as in the country's national language.

* The fees to enter the available schemes and procedures vary a lot between countries. While some countries offer specific fee waivers and incentives for early interactions, this is not the case in most countries. The amount of the fees can be a real obstacle for some medicine developers who may need advice but do not have the necessary funds to pursue it. The poster presented and the tables indicate the prices of the various procedures and some of the available fee waivers.

## Opportunities and incentives

The research highlighted a number of different procedures across Member States. Therefore, developers have many ways to engage in early dialogue with competent authorities across the
European Union. The schemes and procedures available are opportunities in themselves, especially when they are free of charge.

European Union Legislation

N/A

European Union Guidance

N/A

Relevant literature

More