Internal

12 Apr 2023 @ Europe House / Online

1Internal【Opening】
16:00-16:10

Opening Remarks

Mr. Hubertus von Baumbach, President of EFPIA (video)
Mr. Takahiko Iwaya, Chair of EFPIA Japan【Part1 Lectures about Initiatives encouraging innovation】
From Industry
16:10-16:25
16:25-16:40
From Government
16:40-16:55
16:55-17:10(1) Opening the future with the powerof innovation

Ms. Kanako Kikuchi, Board Member of EFPIA Japan(2) Opportunities to enhance Japan’s
global market attractivenessMr. Paul Hudson, Chief Executive Officer, Sanofi(1) EU’s vision for innovation

Mr. Jean-Eric Paquet, EU ambassador(2) Policies of promoting innovation inJapan

Mr. Shinichi Isa, State Minister of MHLW (video)<Formation Change>【Part2 Dialogues; “The importance of continuously seeking for innovations and expectations for the future”】
17:15-17:55(40 min)【Closing】
17:55-18:00

Moderator: someone professional
Panelist 1. Patient
Panelist 2. HCP
Panelist 3. Government
Panelist 4. Industry

Ms. Naomi Sakurai, Japan Federation of Cancer Patient Groups
Dr. Watanabe, Director of Japan Medical Association
Mr. Katsufumi Jo, Assistant Vice Minister of MHLW
Mr. Kasper Bødker Mejlvang, Board Member of EFPIA Japan

Closing Remarks

Mr. Takahiko Iwaya, Chair of EFPIA Japan

2

Internal

Opening Remarks
Mr. Hubertus von Baumbach, Chief Executive Officer, C. H. Boehringer Sohn AG & Co. KG (Video Message)
Mr. Takahiko Iwaya, President and Representative Director, Sanofi K.K.

President of EFPIA
Chair of EFPIA Japan
3

Internal

Part 1 Lectures
Lectures about Initiatives encouraging innovation

4

Internal

EU Japan Health Innovation Forum 2023
- Opening the future with the power of innovation -April 12, 2023

Kanako KIKUCHIEFPIA Japan Board Member
Representative Director and President, UCB Japan Co., Ltd.
5

Internal

EFPIA Japan is delivering patient-centered innovations
Establishment: 2002 (became a general incorporated associationin 2022)
Overview: EFPIA Japan is comprised of European R&D-oriented
pharmaceutical companies operating in Japan. Our mission is tocontribute to healthcare and patients in Japan through the early
introduction of innovative medicines and vaccines, and we aim
to strengthen dialogue with policymakers to improve healthcare
in Japan.
Membership: 23 companies (as of April 2023)
Board Companies
AstraZeneca K.K.

Bayer Yakuhin, Ltd.

GlaxoSmithKline K.K.

Janssen Pharmaceutical K.K.

Merck BioPharma Co., Ltd

Nippon Boehringer Ingelheim Co., Ltd.

Novartis Pharma K.K.

Novo Nordisk Pharma Ltd.

Sanofi K.K.

UCB Japan Co., Ltd.

Percentage of the total sales of
EFPIA Japan member companies
in the ethical drug market in
Japan 1)26%
Proportion of new drugs
launched by EFPIA Japanmember companies
among new drugs launchedrecently in Japan 2)28%1) Approximately 2.8 trillion yen (EFPIA Japan 2021)
2) 46 components (EFPIA Japan 2019 – 21)6

Internal

What EFPIA Japan thinks about innovations are:
 Patients' voices are a source of innovation
 Healthcare innovation aims to:• Bring hope to patients and change & save lives of patients andtheir families• Extend healthy life expectancy, energize society, andcontribute to better communities• Make science and medical practice to progress Each one, even one who is supporting others, may
become a patient one day.

• Stakeholders should understand each other and help to create
innovations

7

Internal

EFPIA Japan executes the five strategies to continue creating innovations
and bring them to patients
Drive pharmaceutical innovations while sustaining universal healthcare
Be engaged in the development of cost-effectiveness assessment processes
that ensure patient access
Promote the improvement of R&D and regulatory environments
Support the enhancement of health literacy
Leverage innovative technologies such as regenerative medicine, gene/cell therapy,
and digital and develop talent8Internal

Drugs & Vaccines innovations in Japan
1. Do innovations occur spontaneously?
2. How can patients access innovations?

(JP)_EFPIA_HTA_Viewpoint-2019Jan.pdf

9Internal

Drugs & Vaccines innovations in Japan
1. Do innovations occur spontaneously?
 Suitable infrastructures and regulations are needed

Agile regulatory frame in line with international standard and ready toaddress/review new technologies
 Appropriate financial conditions are required: Costs? OR Investment?
Let's think about the total benefits that society may gain
• Innovations will protect people suffering from new diseases or currently uncurable diseases• The percentage of pharmaceutical products in the total national healthcare spending has beenaround 20% as direct cost but also help to save overall HC cost

2. How can patients access innovations?

A patient-friendly system must be built to help patients benefit from theinnovations they need while maintaining Universal Healthcare System(JP)_EFPIA_HTA_Viewpoint-2019Jan.pdf

10Internal

An innovation-friendly environment must be built
through:
Building an open ecosystem that fits Japan
Introducing an International harmonized regulatory
system that starts NDA review based on the topline

Industry

Patients

Government

Academia

results of confirmatory clinical trials
Creating opportunities that encourage collaboration
between clinical research core hospitals andpharmaceutical companies
Creating opportunities to discuss how to promoteindustry-government-academia collaborations in thedevelopment of innovative new drugs
11Internal

EFPIA Japan promotes the creation of an environment where thepatient's voice can be heard: Patient Advocacy Support by EFPIA Japan (PASE)
PASE (Patient Advocacy Support by EFPIA Japan):
EFPIA Japan's patient group support project
launched in 2017
Overview: PASE encourages patient groups to act
more energetically and make policymakers reflect
patients' voices in the healthcare system in Japan,
thereby improving the healthcare environment
surrounding patients.
PASE Awards: Every year, EFPIA Japan provides
grants to organizations contributing to theadvancement of patient rights advocacy activities.
Education to patients about disease, treatments, etc.

The 5th PASE Award at EFPIA Day 2022
Source: Kibo-no-Kai, an award winner
EFPIA JAPAN | PASE - Patient support activities

12Internal

EFPIA Japan believes that cost-effectiveness analysis
system should ensures patient access
EFPIA's viewpoint: Four principles of cost-effectiveness analysis (CEA)
EFPIA has significant experience in the application of HTA in European markets. EFPIA suggests the following four
principles for CEA system in Japan.

1. Should not be used for reimbursement determination in order to protect patients'
access
2. Should be used as a complementary tool for the system of drug pricing andreimbursement
3. Evaluate ethical and social value of pharmaceuticals from a long-term perspective
4. Involve all stakeholders in comprehensive evaluation to secure transparency(JP)_EFPIA_HTA_Viewpoint-2019Jan.pdf
13Internal

Decreased priority of the Japanese market may affectthe launch of new drugs in Japan
Discontinue, postpone or delay product launch in Japan
Change in priority of the Japanese market vs othercountries after the fundamental reform of the drug
pricing system
Unit: Number of companies, n = 10

6
5

5
4

3

3
2

2

• Decreases in the NHI price at the initial listing,revisions in the future, and their predictability• Need for developing products only for Japan(due to the 2-week prescription limit for newly
launched drugs)• Influence on other countries like China where
Japan's NHI prices are referred to as pricing
data

1
0

0

0

高くなった
Increased

やや高くなった
Slightly higher

変わらない
No change

やや低くなった
Slightly lower

低くなった
LoweredSource: Survey on 10 EFPIA Japan board companies (September 2022)

14

Internal

For global pharmaceutical companies to bring innovative new
drugs to Japanese patients as soon as possible, Japan needs tohave a supportive drug pricing system


Maintain the current system that ensures prompt NHI listing andreimbursement following the NDA approval;

Evaluate the value of innovative drugs appropriately;Provide incentives for launching new drugs in Japan earlier than othercountries;

Have a high predictability;Be sustainable

15

Internal

Summary: EFPIA sees the following challenges as opportunities and willcontinue to engage in dialogue with various stakeholders
Creating an environment that promotes innovation
Building a patient-friendly system to help patients benefit from the innovations
they need
Being engaged in the development of Cost-Effectiveness Assessment processes
that ensure patient access
Building a drug pricing system that rewards and incentivizes innovation so as tosupport the stable delivery of innovative new drugs to Japanese patients

16

Internal

Thank you17

Internal

EU Japan Health Innovation Forum 2023
- Opportunities to enhance Japan’s global market attractiveness -April 12, 2023

Paul HUDSON

Chief Executive Officer, Sanofi
18

Internal

Japan has long been a reference in universal health coverage and historically astrategic market for the global biopharmaceutical sector
Japan’s Universal Health Coverage has long been a model for manyother countries in the world.

The time between marketing authorization and availability of new medicines inJapan is in average 60 days, compared to over 500 days in average in Europe.

Source: “Japanese universal health coverage: evolution, achievements, and challenges “, The Lancet, 2011

Source: EFPIA

As such, Japan has been a strategic market for the global biopharmaceutical industry, and our sector has historically been
invested significantly in Japan:• For our patients in Japan and around the world, our sector has been and continues to be at the core of the R&D and production efforts to fight COVID
pandemic and other life-threatening diseases.
• Our sector invests the most in R&D in Japan, with 14 trillion of yen over the last decade.
• And our sector is supporting over 140,000 jobs across the country.

19Internal

However, in recent years, Japan has been losing the key elements of its market
attractiveness.

20
Source: EFPIA

Internal

Innovation Pipeline is exciting and transformative – Japan should not be left
out•

In 2022, global R&D funding from the large pharmaceutical sector remained high, with a record $138
billion invested in R&D by the 15 largest pharmaceutical companies. This represents an increase of
43% since 2017.

Source: IQVIA EFPIA

21

Internal

To turn around the situation, there are 3 Win-Wins to be taken advantage of todrive a pro-innovation health ecosystem in Japan
Ensure sustainable funding investment on innovation.
o Investing in innovative medicines to preserve good health and extending productivity of the super ageing populationo Investing in health ecosystem to enhance pandemic preparedness

Improve the current pricing system for higher predictability and better
recognition of innovation.
oProviding high predictabilityoMaintaining medicines’ prices during patent periodoIncentivizing early new launches in Japan

Enhance R&D environment and regulatory harmonization with global
standards to accelerate introduction of innovative medicines.
oPromoting industry-government-academia collaboration in the development of advanced therapy medicinal products (ATMP).

o

Encouraging and supporting capability building, experience sharing, and talent development between EU/EMA and Japan.

22

Internal

We are committed to close collaboration with the Japanese government to codevelop Japan’s health eco-system•

The European-based biopharma companies have been working closely with various governments in co-development life
science strategy.

•

We are committed to working closely with Japan government to co-develop a pro-innovation health ecosystem, toenhance Japan’s health security and global market attractiveness.

•

We suggest leverage this EU-Japan Health Innovation Forum as an annual platform for the government-Industry strategic
dialogue, to co-develop end-to-end strategies for a better and brighter pharmaceutical sector in Japan.

France Innovation Santé 2030 is established in a concerted manner between the State andthe pharmaceutical, device and diagnostic sectors. The strategic vision is co-constructed on
the basis of shared diagnosis and challenges, and the operational follow-up of the measures
is then ensured by people from the industrial sector with regular meetings with the different
ministries concerned (health, industry, research) and Macron’s office.

The Danish National Life Sciences Council enables continuous alignment on key policy goals
between various stakeholders, including industry, government stakeholders, and patientorganizations.

23

Internal

Thank you very much !
ありがとうございました!

24

EU’s vision for innovation
EU’s power for innovation and DX
for people, patients and innovation
Jean-Eric Paquet
Ambassador of the European Union to Japan
EU-Japan Health Innovation ForumMinistry of
Health, Labourand Welfare

For people, life and future

2021年4月1日

E U - J a p a n H e a l t h I n n o va t i o n Fo r u m 2 0 2 3
Innovation Promotion Policy in Japan

Shinichi Isa
State Minister of Health, Labour and WelfareImportance of Innovation Promotion

 The pharmaceutical industry is an important industry
that contributes to the improvement of the nation’s
health and medical care and will be at the core of future
economic growth Constant promotion of innovation is a must to
deliver the innovative new drug to the nation and tocontinue to grow as an industry
 The followings are being conducted as the Japanese
Government :1. Develop strategies on the pharma industrial policy
2. Support collaboration with academia and venturecompanies
3. Improve environmental foundation for thecreation of innovation27

1. Strategies –Pharma Industry Vision 2021 –(The vision that the pharma industrial policy aims to achieve) Improvement of scientific and technological capabilities and realization of innovation are
indispensable for the development of the pharma industry, which is a knowledge- and technologyintensive industry, therefore, the pharma industrial policy is promoted with the aim of realizing thefollowing 2 points:
1.

Contribute to prolonging the healthy life expectancy of Japan through innovative drug
discovery as one of the world’s most advanced drug discovery countries, as well as toindustrial and economic development through the improvement of medical research andindustrial technology capabilities

2.

Pass on to the next generation a society where the nation can securely receive a goodquality of medical care through quality assurance and a stable supply of medicinal products

January 7 th, 2023
LEQEMBI™（Lecanemab）obtained
accelerated approval by the US FDA as atherapeutic agent for Alzheimer’s disease28

2 . C o l l a b o r a t i o n – Tr e n d s i n D r u g D e v e l o p m e n t –Trends in drug development
Collaboration between
pharmaceutical companies andacademia/ventures is the essential
requirement for innovative new
drug development

Strengths and challenges in Japan

Basic
research

Horizontal division of work isincreasing globally

Translation
al research

Build the ecosystem, and promote
the creation of innovation
through collaboration
Formation of an open-innovation
community where innovation is
promoted organically, including
entries from overseas or otherindustries, is required.

Commerciali
zationpreparation
toCommerciali
zation Academia and pharmaceuticalcompanies/peripheral players
are enriched– Nobel Prize-worthy
innovative researches arebeing conducted– Domestic /foreign mega
pharma companies andmedium-sized
Insufficientpharmaceuticalcompanies with strengths
in technology exist
 On the other hand, the support
function provided by privateorganizations alone intranslational research are notwell established as in the US,
and there was a backgroundissue of difficulty inconnecting the academia
seeds to industrialization29

To t a l S u p p o r t P r o j e c t f o r M e d i c a l V e n t u r e s ( M E D I S O ) MEDISO（MEDical Innovation Support Office）is a project to provide total support for
issues emerged at each step from research and development to launch to connect theseeds for medicinal products and medical devices owned by academia and venturecompanies to practical use.
MEDISOMEDISO secretariat

Venturecompanies, etc.
eligible forsupport

Receive consultation
Consultation

Total
support

Receive consultations
through the
dedicated portal
website “MEDISO”

医療ベンチャー・相談業務 情報共有ツール
検索・出力
●相談情報

専門家情報

支援情報

共同研究者情報

〇進捗状況
検索

相談種別

事業者
検索結果一覧
事業者

相談日付

相談種別

相談内容

事業者
相談日付
相談種別
相談内容
・・・

CSV出力

フォーム出力戻る

Organize
into the（Phone/email also
consultation Interviews,
etc.
available)
chartdependingon the case
Provide one-stop comprehensive support for venture companies, etc.
Functions of the secretariat
Dedicated portal website
 Receive consultations, andFull-time supporter
examines theconsultation
contents

examine the contents

Information
provision
Identification ofcompanies
eligible forsupport

対象製品情報

事業者情報

相談情報

Part-time supporters (experts on
legal
regulation
compliance,
marketing, business plan, fundraise,businessstrategy,
intellectual property strategy,
globalization, etc.)

Receiveconsultations,Supporter
provideinformation, etc. interview, andmatching

https://mediso.mhlw.go.jp/

Support for
presentationmaterial
preparation

On-lineinterview alsoavailable Prepare support plan, arrange
interviews, matching, andsupport for presentationmaterial preparation
 Market/IP surveys, etc., forprospective seeds
 Coordinate hands-on matching30

Project for Enhancing the Drug Discovery Ecosystem
Supplementary budget for 2022: 300 billion JPY * supplementary budget for 2021: 50 billion JPYDrug discovery ventures are highly difficult to achieve commercialization due to their special businessmodels: 1. Long development period, 2. Large amount of development funds, 3. Low success rates, 4. No sales
unless regulatory approval is obtained. In particular, the risk involved in Phase I and II clinical trials is still
high, however, the development funds jump to the scale of 5-10 billion yen.
Globally, the development of new medicinal products has shifted to drug discovery ventures. In the new
drug/venture ecosystem in Japan vulnerable than that of the US, the smooth raising of funds that drug
discovery ventures need is difficult.

 Based also on round-table discussions, the scope of eligible business that supports practicaldevelopment in collaboration with VC is expanded other than those related to infectious diseases inorder to truly enhance the drug discovery ventures ecosystem.

Diagram for the project

Diagram for risk and funds of drug
discovery development
Basic
researchPreclinical

PI
study

P II
study

P III
study

5 millions Billions

Severalbillions

Tens ofTens ofbillions
billions
Fundraising from themarket, companies, etc.

Success rate
Several hundreds

Required funds (JPY) of millions
Main investor

Angel, etc.

Investment from VC, etc.

Applicati
on forapproval

Share of the # of drug discovery development
products for medicinal products in worldwide
Major pharma
Medium-sized pharma
Small-sized pharma
VenturesOn the condition of VC investment, subsidies
up to 2 times the private investment⇒ Smooth securing of clinical trial fees + callfor further private funds
InvestGovernment(AMED)

CertifCertify ied
VC(Require a certain
level of investment asa requirement for
support)Hands-onsupportDrugdiscovery
ventures

Subsidy based on thisproject(incl. development costs for preclinical, Phase
I and II clinical trials)

31

Project for Improving Biopharmaceutical Manufacturing
B a s e s , e t c . Supplementary budget for 2022: 100 billion JPY * supplementary budget for 2021: 223.78 billion JPY
Details of the project

Diagram of the project

Project objectives/overview
 Having the capabilities to develop and produce vaccines domesticallyis extremely important from the perspective of diplomacy andsecurity, as well as contributing to the preservation of the health of
the nation. Therefore, the Cabinet approved the strategy forstrengthening vaccine development and production as a national
strategy in June 2021 to commit continuously on a long-term basis.

(1) Project for improving manufacturing bases for vaccine•

Support is provided for the installation, etc., of dual-use equipmentwith dual-use capabilities, which can manufacture biopharmaceuticals
that companies normally produce under normal circumstances andvaccines for infectious diseases under emergency circumstances, suchas pandemics.
<Diagram of the project>
 Renovations necessary to convert existing facilities/equipment todual-use
 Installation of new dual-use equipment, facility improvement, etc.

 Many of the vaccines for COVID-19 are innovative
biopharmaceuticals different from conventional vaccines, such as
genetic vaccines, however, the number of manufacturing bases forsuch innovative vaccines is currently limited in Japan. In addition,
many of the components required for vaccine manufacturing (culture
media, culture bags, etc.) are dependent on imports, resulting inissues, including delivery delays.

Normalcircumstance In this project, it secures the dual-use equipment that manufacturesbiopharmaceuticals, meeting the needs of companies under normal
circumstances and can switch to vaccine manufacturing underemergency circumstances as a preparation for future variants andnew infectious diseases. In addition, it provides support forformulation and filling equipment that are indispensable for vaccine
manufacturing, as well as manufacturing equipment of components
necessary for medicinal product manufacturing.

Biopharmaceuti
calsOutcome objective
 Build the structure that can initiate prompt vaccine manufacturing
domestically in the event of future variants or new infectious
diseases occurrence by supporting the formation of dual-use
manufacturing bases compatible with multiple drug discovery
technologies and methods (modality).

<Diagram of dual-use equipment>*Image picture

Switch(dual-use)

Emergency
circumstance

Vaccines(2) Project for improving manufacturing bases for formulation andcomponents, etc.

•

Support is provided for the installation, etc., of formulationequipment and manufacturing equipment of components, etc.,
indispensable for vaccine manufacturing.

Condition (eligible subject, eligible act, subsidy rate, etc.)
Government

subsidy(10/10)

Corporation
with a fundestablished

Subsidy

Privatecompany, etc.

(1) 9/10(2) Large-sized companies 2/3,
small and medium-sized companies 3/4

Formulationequipment

Single-use bag

Filters32

3. Environmental foundation improvement – Promotion of Whole Genome
Analysis, etc. Action Plan –“Whole Genome Analysis, etc. Action Plan 2022” (Developed on September 30, 2022)
The stance of medical care aimed by the promotion of whole genome analysis, etc.

 Aiming to “conquer cancer and intractable diseases, etc.” in the future by proceeding with the accumulation of strategic data and promoting
research and drug discovery using such data to deliver high-quality medical care for the nation is the stance of medical care aimed by thepromotion of whole genome analysis, etc.
● In addition, the early introduction of the analysis results into daily medical practice and the realization of personalized medicines are further
promoted.
Returns for patients Provide novel therapy, etc., by drug
development
 Provide opportunities to participate inclinical research and studies, etc.
 Provide prevention, early
detection/diagnosis, and therapy, etc.
based on individual genome information

Conquer cancer and intractablediseases, etc.

Promotion of PPI
and ELSI
Accumulation ofstrategic data

Deliver high-quality
medical care for thenationResearch and drug discovery
using the accumulated data
Realize new personalized
medicines
Introduce the analysis results into
daily medical practice

Whole genome
analysis, etc.

Data provisionanddata utilization

Construct highquality information
infrastructure Whole genome data
 Multiomics data
 Clinical information, etc.

* PPI: Patient and Public Involvement, ELSI: Ethical, Legal and Social Issues*The term “Cancer” in this action plan presumes cancer types, including refractory, rare, childhood, and hereditary cancers, for which a certain
effect is expected from the whole genome analysis, etc., but it is difficult for the private sector alone to conduct research and drug discovery, etc.

33

3. Environmental foundation improvement –Medical DX Promotion –● Contribute to individual health improvement by being able to understand lifelong healthcare data
centrally by oneself from birth to present● With the consent of the person, possible to receive high-quality medical care seamlessly through thesharing of necessary medical information among medical institutions, etc., nationwide● Promote operational efficiency and effective use of human resources in the medical setting throughdigitalization● Promote pharmaceutical and healthcare industries such as drug discovery and clinical trials, etc.,
through secondary use of healthcare data
Receive safe andsecure medical care
into the future

Conferences, etc.

Drug discovery/clinical trials

Municipality

・Municipal
medical checkup
・Vaccination
・Infant healthexamination

PromotePharmaceutical/
healthcare industry

PersonPromotion

System such as Onlineof PHR
Eligibility Verification

Medical institutions, etc.

・Electronic medical chart (injuries and diseases name,information on allergy, infectious disease, drug contraindications,prescriptions, and tests (emergency, lifestyle-related diseases))・Health insurance claims ・Electronicprescription ・Designated checkup

Provide seamless, highquality medical care
Promote operational
efficiency and effective
use of human resourcesin the medical setting34

3. Environmental foundation improvement – Regulatory Harmonization
Initiatives with EMA –MHLW/PMDA has conducted international regulatory harmonization with EMA, combining
multinational and bilateral collaboration
 Multinational cooperation:
Improve common global regulatory basis through collaborations in developing common guidelines forpharmaceuticals, etc. (ICH) and in a place where the direction, etc. of regulatory harmonization
regarding regulatory affairs are instructed and coordinated (ICMRA) Bilateral cooperation：
Implement regulatory harmonization from a perspective of practical operations through collaborationsin specific disease areas, including rare diseases, participation of PMDA experts in EMA reviews (Open
Project), and mutual dispatch of expert personnels［Multinational cooperation (examples)］ICH（International Council for Harmonisation of TechnicalRequirements for Pharmaceuticals for Human Use)
○International conference where drug regulatory authorities andrepresentatives of pharmaceutical industry collaborate to develop
guidelines for regulations of pharmaceuticals○Started in 1990（Europe and Japan are both early founding
memebers）

ICMRA（International Coalition of Medicines
Regulatory Authorities)〇A place where the direction, etc. of regulatory harmonization
regarding regulatory affairs are instructed and coordinated〇 Composed of top officials of drug regulatory authorities fromapproximately 30 countries and regions, including Asia, Europe
and the US〇 Started in 2013
〇Chair: Executive Director of EMA (EU) Vice-Chair: Chief
Executive of PMDA (Japan) and others［Bilateral cooperation (examples)］Collaboration in specific disease areas (FDA also
participates)○Collaborate on regulatory concepts and responses, etc. by area(cluster)（Example)・Concept of development and review collaboration in therare disease area
・GCP*Initiative (sharing of GCP audit information between
Japan, the US and Europe)*GCP: Good Clinical PracticeParticipation in EMA review (Open Project)○ In light of COVID-19, PMDA reviewers participated in EMA
reviews and provide opinions. It will be expanded into otherareas in the future.

Mutual dispatch of expert personnels○Long-term dispatch of experts from PMDA to EMA as liaisons○Short-term dispatch of topic-specific experts from EMA to
PMDA

35

3. Environmental foundation improvement – Japanese Regulatory System
to Asian Countries –Basic Principles of the Asia Health and Wellbeing Initiative(Approved by Headquarters for Healthcare Policy in July 2016, revised in July 2018)

Proceed with initiatives using a mutually beneficial approach in order to realize a society of good
health and longevity with UHC and to create a new Asia where sustainable economic growth is possible.
Social system
improvement,
e.g. insurance

Dissemination of
medical andnursing skills
Expansion ofJapanese private
business

Access to
medicinal products
and medical
devices

Human resource
development

Utilize guidelines agreed in the ICH*, etc., as a regulatory basis*: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Grand Design for Asian Pharmaceutical and Medical Device Regulatory
Harmonization (Approved by Headquarters for Healthcare Policy in June 2019 and July 2020)
Enhancement of clinicaldevelopment structure

Build a network for hub sites that
conduct clinical studies in the Asian
region.
Lead to prompt and low-cost
implementation of drug and medical
device development.
→ Establish hub sites and a network incancer and infectious disease areas目
アジアジア域内で標

Promotion of regulatory
affairs harmonization

Develop a market without barriers by establishinginternationally harmonized regulations in the Asian
region.
Aim for rapid introduction of excellent Japanese
products in Asian countries.
→ Asia Training Center for Pharmaceuticals and Medical
Devices Regulatory Affairs (PMDA-ATC)→ Multi and bilateral cooperation between regulatory
authorities→ Accelerated approval in the partner country thatreferred to the review results in Japan

アジアジア域内で

36

Ｇ７ Nagasaki Health Ministers’ meeting○ Disseminate the directions and actions of G7 regarding strengthening prevention, preparation, andresponse to future public health crises, contributing to achieving more resilient, equitable, andsustainable Universal Health Coverage (UHC), and promoting health innovation that supports thoseefforts, aiming to “better recovery” from the COVID-19 pandemic.

<Overview of Ministers’ meeting>○Date:○Place：○Venue:Saturday, May 13 and Sunday, May 14, 2023
Nagasaki City, Nagasaki Prefecture
Dejima Messe Nagasaki

Nagasaki City, the host city, has been actively interacting withforeign countries for a long time serving as a trading port, and is
the place where Western medicine was introduced in Japan. The
city has a proven accomplishment of contributing to global
medical care and public health areas, mainly through Nagasaki
University, which owns the National Research Center for theControl and Prevention of Infectious Diseases and the Institute ofTropical Medicine, and is a perfect place to have discussions
about various international health issues.

<Agenda (draft)>
The following 3 points are main agenda:
１．Build and strengthen the global healtharchitecture to respond to the publichealth crisis
２．Contribute to achieving more resilient,equitable, and sustainable Universal
Health Coverage through theenhancement of the health system
３．Promote health innovation to respondto various health issues（*) Universal Health Coverage (UHC)
The state where every person can receive healthcare

Dejima Messe Nagasaki

Night view of the Portof Nagasaki

services, including appropriate prevention, treatment,
and rehabilitation, at a payable cost37Internal

Part 2 Dialogues“The importance of continuously seeking for innovations
and expectations for the future”

38

Internal

Closing Remarks
Mr. Takahiko Iwaya, President and Representative Director, Sanofi K.K.

President of EFPIA Japan
39

Internal

The END

See you again!
終了

ありがとうございました。

40