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)
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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
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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