PMDA International Vision and Cooperation with Asian Drug … · PMDA International Vision and Cooperation with . Asian Drug Regulatory Authorities. Toshiyoshi Tominaga, Ph.D. Director,

PMDA International Vision and Cooperation with Asian Drug Regulatory Authorities

Toshiyoshi Tominaga, Ph.D.Director, Office of International ProgramsPharmaceuticals and Medical Devices Agency

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India

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Disclaimer

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1. Generally on International Activities

2. International Master Plan

3. PMDA EPOCH

4. PMDA’s Activities in Asia

Contents

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1. Generally on International Activities

2. International Master Plan

3. PMDA EPOCH

4. PMDA’s Activities in Asia

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Contents

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaGenerally on International Activities (1)

1. Serve the DRA’s needs

2. Construct win-win situation w. foreign DRAs

3. Synergize (or at least be compatible) with domestic measures4. (sometimes) employ diplomacy to gain influence

Int’l Activities by Drug Reg. Authorities must…

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Random “international Cooperation” sounds nice but leads to waste

International Activities need to be consciously designed and conducted to achieve certain goals related to the DRA’s (a)desired international status, and(b)overall goal.


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Contents

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaInternational Mater PlanNeed for Master Plan

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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaPhilosophy, Vision, and Roadmap

Current Situation

Int’l vision

Desired Achievements

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PMDA PhilosophyTime

2020

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaContents

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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaPMDA International Vision

Concrete goals for PMDA to attain by 2020 as one of world’s top three medical products regulatory agencies comparable to USFDA and EMA

(Published in November 2011)

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Secure the highest level Excellence in Performance in the following aspects:• A) Quality and speed in product

reviews, safety measures, and relief services (PMDA’s Safety Triangle )

• B) Quality and quantity of regulatory science research

• C) Quality, quantity and speed of information transmission to the world

Maintain close Partnership with the Orient for common benefits through:• A) Cooperating to improve the level of

medical products regulation across Asia.• B) Communication of information and

opinions to the world as a member of the Asian community

Actively Contribute to International Harmonization

of regulations, guidelines, and standards for the benefit of both Japan and the world

- PMDA toward 2020 -

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What is PMDA EPOCH? (1)

1.Secure the highest level Excellence in Performance in:

A) Product review, Safety Measures, and Relief Services

B) Regulatory Science ResearchC) Information transmission to the world

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaDoes Japan count as one of the Top 3?

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Human Resource Development in ＰＭＤＡ

On-site Training(hospitals, factories)

Basic Training(human skills, languages, etc.)

Human Resource Development Plan (Training) to Improve Knowledge & Skills of PMDA staff

Overseas organizationsFDA, EMA, OECDUniversities, institutions

in Japan

Long-term dispatch

Participation, discussion

Challenges for the Future1. Increase of training for mid-level and management-level staff (Leader Development)2. Increase of long-term dispatches to overseas regulatory authorities3. Increase of long-tem dispatches to universities or other education institutions

(provision of the opportunity to obtain a Ph.D)

Specialized Training(case studies, etc.)

Special Training(latest scientific topics)

International academic societies, international meetings: ICH, GHTF, DIA, etc.


FY2004 2005 2006 2007 2008 2009 2010 2011

Office of NewDrug

O. Safety

O. of Int’l Programs

O. of Reg. Science

O. of Stds & GlsDev.

Expansion of Offices at PMDA

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O. of BiologicsO. of Medical Devices

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaOrganization Chart of PMDA as of October 2011

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Office of Safety Ⅰ, Ⅱ

Offices of General Affairs/ Financial ManagementOffice of Planning and Coordination

PMS

Chief Management Officer

Office of Review Administration

Office of Review Management

Office of Medical Devices Ⅰ, Ⅱ

Office of New Drug I - Ⅴ

Office of Conformity Audit

Office of OTC/Generic Drugs

Office of Biologics Ⅰ, Ⅱ

Office of Relief Funds

Office of GMP/QMS Inspection

Review

（Inspections such as GLP/GCP and

GPSP）（GMP/ QMS Inspection)

Chief Executive

Auditor

Auditor

Chief Safety Officer

Office of Regulatory Science Operations

Office of International Programs, International Liaison Officers

Chief Relief Officer

JP, StandardsOffice of Standards and GLs Development

Senior Executive Director

Executive Director

Executive Director

Director(Center for

Product Evaluation)

Associate Center

Director

Associate Center

Director

Associate Center

Director

Associate Center

Director

Associate Center

Director


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Confidentiality Arrangements

EC/EMAUS FDAMHRA (U.K.)Swissmedic (Switzerland)HAS (Singapore)Health CanadaIMB (Ireland)TGA (Australia)

Must•cooperate to excel •excel to cooperate•build Win-Win Situation


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EMA-MHLW/PMDA, EMA-FDA InteractionsJanuary 2009 – August 2011

2009

Cooperation across Atlantic / Pacific

0

20

40

60

80

100

120

Jan Mar May July Sep Nov Jan Mar May July Sep Nov Jan Mar May July

EMA-MHLW/PMDA EMA-FDA

2010 2011DIA 年鑑「The Liaison Placements Concept - Introduction」 by Emmer Cookeより抜粋・加工


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2. Maintain close Partnership with the Orient for common benefits

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaAsia as Japan’s Future

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3. Actively Contribute to International Harmonization of regulations, guidelines, and standards.

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaCurrent Harmonization Activities

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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaInternational “Regulatory“ Harmonization

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Coming Soon!

PMDA Roadmap toward 2020

PMDA Roadmap toward 2020


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Structure of Roadmap (planned)

Time(Year)

PMDA FunctionsProduct Review

Safety

OthersItem of Vision2012

2016

2020

E O C HP

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaContents

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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaPMDA Activities in Asia

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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaChina/Korea/Japan Tripartite Cooperation

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Three Joint Projects

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India2011 China-Korea-Japan Tripartite Meeting

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Source: APEC

(Life Science Innovation Forum)

Member: Canada, China, Japan, Korea, Peru, Taiwan, Thailand, USA

LSIF

Leaders Meeting

Ministerial Meeting

Senior Officials Meeting

Committee onTrade and Investment

APEC, LSIF, and RHSC

Regulatory Harmonization Steering Committee (RHSC)

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APEC Roadmap to Promote MRCTMHLW/PMDA Proposal, RHSC approval March 2011

Assessment of Status Quo

(2011, 2012)

Development of the T/W curriculumTraining/workshop for various workers

(2013-2015)

Interim assessment of

the achievementRecommendation to improve MRCT

(2016)

Training/workshop geared to

reach the goalRecommendation

for regulatory harmonization(2017-2020)

Goal：To facilitate MRCTs and acceptance of MRCT results for drug review by regulatory authorities in APEC region.


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APEC Multi-Regional Clinical Trial Workshop (Sep. 13-15, 2010, Seoul, Korea)


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APEC Multi-Regional Clinical Trial Workshop (Nov. 1-2, 2011, Tokyo Japan)

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaChina-Japan Bilateral Meeting

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Starting from 2010 for the purpose of:

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaChina-Japan WG - Project 1

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Category Item Japan ChinaApplication Form Yes: Clinical Trial

notification form (in Japanese)

Yes (in Chinese)Huge IND materials required

Protocol Yes (in Japanese in principle)

Yes (in Chinese)

Informed Consent form

Yes (in Japanese) IND Application Materials

IB (Investigator’s Brochure)

Yes (in Japanese in principle, English is acceptable in part)

Yes (in Chinese)

Investigator’s CV No No (Submit list to the local authority for the medical sites application)

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Project 1: GCP Comparison Table


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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaChina-Japan Symposium

To promote dialogue and cooperation between the agencies

2010 May 2011 March 2012 March

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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaPMDA Training Seminar

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2010 November – DecemberPMDA’s role in regulation, and Scientific review process on new drug applications biological applications35 trainees participated from Indonesia, Singapore, China, Taiwan, Korea

and Nigeria

2011 DecemberPharmaceutical GMP inspection

27 trainees participated from Korea, India, Indonesia….

4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaTrainings for individual Trainees

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Medium-term training

Dr. Kondo with Trainees from KFDA

Dr. Kondo with Trainees from Taiwan FDA


Our goal is to…

Promote Global & Domestic Public Health

through International Activities

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Documents

PMDA International Vision and Cooperation with Asian Drug … · PMDA International Vision and Cooperation with . Asian Drug Regulatory Authorities. Toshiyoshi Tominaga, Ph.D. Director,