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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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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
1. Generally on International Activities
2. International Master Plan
3. PMDA EPOCH
4. PMDA’s Activities in Asia
Contents
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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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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.
4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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
4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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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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What is PMDA EPOCH? (2)
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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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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What is PMDA EPOCH? (3)
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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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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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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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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)
4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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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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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
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
4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaChina-Japan WG - Project 2
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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaChina-Japan WG - Project 3
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4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, IndiaChina-Japan WG - Project 4
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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
4th Annual Conference on Drug Discovery and Clinical Development in India | November 14-18, New Delhi, India
Our goal is to…
Promote Global & Domestic Public Health
through International Activities
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