Latest Trend of Pharmaceutical and Medical Device

Regulation, and International Cooperation of Japan

Yoshikazu Hayashi, Ph.D.Senior Executive Director, PMDA

5th February 2020

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Dr.Fujiwara’s Priorities

“Rational Medicine” Initiative

Patient FirstAccess FirstSafety FirstAsia First

< 4Fs >

by Fujiwara

Regulatory ScienceBenefit Risk

??

by Kondo4th India - Japan Medical Products Regulatory Symposium

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Patient First

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In May 2019, PMDA established Patient Centricity Working Group to:

Patient EngagementInitiatives within PMDA

• discuss how patients can be involved in PMDA’s review and safety services

• develop and publish guidance and principles on patient and public involvement at PMDA

4th India - Japan Medical Products Regulatory SymposiumPink Sheet (21st June, 2019)

54th India - Japan Medical Products Regulatory Symposium

Access First

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International cooperation

Benefit Risk

??

4th India - Japan Medical Products Regulatory Symposium

New Technologies

etc…

Innovative technologies

CAR-T cell therapy Genome editing

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International Collaboration

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Safety First

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India30%

South Korea26%

China24%

Germany10%

Others10%

Generic drug substance suppliers in Japan

https://www.mhlw.go.jp/bunya/iryou/kouhatu-iyaku/dl/h24-02_3.pdf

Importance of Indian Pharmaceutical Quality

Indian pharmaceuticalsThe third largest market by 2020?49% of US DMF registration(in 2012)https://www.indembassy-tokyo.gov.in/Make_In_India/Field_Brochure_Pharmaceuticals.pdf

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MissionLead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates

Main benefits for Members

• Training opportunities• International GMP harmonization• High standards• Sharing of inspection reports

Benefits for Industry

• Reduced duplication of inspections• Cost savings• Export facilitation• Enhanced market access

PIC/SPharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

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PIC/S Members

49 participating authoritiesAs of January 2020

https://picscheme.org/en/members 4th India - Japan Medical Products Regulatory Symposium

Participating authorities

Approval of Trastuzumab for HER2 positive breast cancer

Approval of Gefitinibfor EGFR positive NSCLC

Notification on Regulation of CDx & relevant drugs in Japan

2011 20132001

2018

2019

PMDA Workshop forCDx Repositioning

drug

drug

drug

Comprehensive Genome Profiling by NGS

Revision of Guidance for CGP

Development of Liquid Biopsy

The first time approval of oncology panel in Japan

SakigakeDesignation

Single Biomarker CDx

2020

Regulatory Path for Innovative Diagnostics Promotes the Precision Medicine

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Asia First

Access to innovative pharmaceuticals and medical devices is insufficient in Asiancountries/regions.Access to pharmaceuticals and medical devices is a complex issue related to research and

development, regulation, securing of intellectual property, etc.Globalization and diversification of products mean increasing regulations and heightened

importance of international cooperation.

Promotion of Asian Pharmaceutical and Medical Device Regulatory Harmonization

Basic Principles of the Asia Health and Wellbeing Initiative (AHWIN, established by the Headquarters for Healthcare Policy of Japan in July 2016; revised July 2018)• In order to contribute to resolving the ‘drug lag’ between Japan and Asia, Japan will promote harmonization efforts to make pharmaceutical approval systems and safety regulations more effective and rational by ensuring interoperability in Asian countries/regions of data used for approval of pharmaceuticals.

Issues of access to pharmaceuticals and medical devices

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Platform Formation

Understanding needs and establishing a utilization scheme

Promotion and coordination with the business community’s activities

Strengthening the system

Human resource development

Support for establishment and maintenance of clinical trial sites

International standardization, promotion of Reliance

Promotion of Asian joint clinical trials

Pharmaceuticals

Technical support tied to establishment of clinical trial site

Medical devices and IVDs

Promoting establishment of regulations according to product characteristics

Regenerative medicine products

Shared principles and values

(Regulatory science)

Respect the position of Asian countries/regions

(Equal partnership)

Coordination and cooperation with the business community’s

activities

Infrastructure development with both a “hard” and “soft”

approach

Four Basic Approaches

Asian Grand Design, June 2019

4th India - Japan Medical Products Regulatory Symposium

Action 1: Establishing a system and framework Action 2: Enhancement of clinical trial system

Action 3: Promotion of regulatory harmonization

Action 4: Handling individual areas

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Bilateral cooperation between MHLW/PMDA and MoHFW/CDSCO

Apr., 2019, Japan

Aug., 2018, India

Apr., 2017, Japan

May, 2016, India

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For early patient access of high quality products

International collaboration (ICH, PIC/S, etc.)

International harmonization (standards/guidance)

Summary

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Thank you!

Let’s work together for patients in India/Japan

and also in the world !

4th India - Japan Medical Products Regulatory Symposium