Transcript PHARMACEUTICAL HARMONISATION

ASEAN Pharmaceutical
Harmonization
Selvaraja Seerangam
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
V Conference of PANDRH 2008
17-19 November 2008, Argentina
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Presentation Outline
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About ASEAN
Background
Economic Integration
Current Status
Issues & Challenges
Conclusion
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ASEAN MAP
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History
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Association of Southeast Asian Nations
(ASEAN) established on 8th Aug 1967 in
Bangkok by 5 original members namely
Indonesia, Malaysia, Philippines, Singapore
and Thailand
Brunei Darussalam joined on 8th Jan 1984
Vietnam on 28th July 1995
Lao PDR and Myanmar on 23th July 1997
Cambodia on 30th April 1999
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Facts
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ASEAN region has a population of about 560
million
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Combined gross domestic product almost
US$ 1,100 billion
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Total trade of about US$ 1,400 billion
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ASEAN- The Goal
ASEAN Summit
ASEAN Economic Community (AEC)
“by the year 2015….. ASEAN will be
A Single Market and A Single Production
Base”
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Free flow of Goods
Free flow of Services
Free flow of Investment
Free flow of Capitals
Free flow of Skilled Labour
ASEAN Free Trade Area (AFTA)
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AFTA is a collective effort by ASEAN to
reduce/eliminate tariffs in intra-ASEAN trade in
the goods sector.
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Objective of AFTA is primarily to enhance
ASEAN’s position as a competitive production
base for regional and global markets
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ACCSQ- to facilitate AFTA
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The ASEAN Consultative Committee for Standards and
Quality (ACCSQ) was formed in 1992 by Senior
Economic Official Meeting (SEOM) to facilitate and
complement the ASEAN Free Trade Area (AFTA).
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Concept of ASEAN pharmaceutical harmonization was
presented by Malaysia and agreed upon by the Senior
Economic Officials Meeting (SEOM) in 1999.
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The Pharmaceutical Product Working Group (PPWG) was
formed in 1999. Malaysia hosted the 1st PPWG meeting
and was appointed the Chair and Thailand the Co-Chair.
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ACCSQ Agenda
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Facilitation of the realization of the ASEAN
economic community
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Working Groups and Product Working
Groups
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Cooperation with dialogue partners and other
organizations on standards and conformance
ACCSQ-PPWG
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Economic Cooperation
ASEAN Summit
AEM
SEOM
ACCSQ -Formed in 1992
WGs
WG 1 on MRAs & Standards –
WG 2 on on Accreditation and Conformity
Assessment –
WG 3 Legal Metrology –
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PWGs
-ACC (ASEAN Committee on Cosmetic)
-PPWG (Pharmaceuticals PWG)
- EE PWG (Electrical and Electronic PWG)
- Pf PWG (Prepared Foodstuff PWG)
-TMHS PWG (Traditional Medicine & Health
Supplement PWG)
- MD PWG (Medical Devices PWG)
- A PWG (Automotives PWG)
- RB PWG (Rubber-based PWG)
- WB PWG (Wood-based PWG)
Objective of Pharmaceutical Product
Working Group (PPWG)
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To develop harmonization schemes of
pharmaceutical regulations of the ASEAN
member countries to complement and facilitate
the objective of AFTA, particularly the
elimination of technical barriers to trade posed
by regulations, however without compromising
product quality, efficacy and safety.
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Scope of PPWG
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Exchange of information on existing requirements
and regulations
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Review requirements and regulations, and conduct
comparative studies
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Study other harmonized procedures and regulatory
system
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Develop technical requirements
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Establish common technical documents towards
achieving MRA
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Strategies
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Comparison of existing product registration
requirements for pharmaceuticals
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Development of common technical requirements
(CTR) for pharmaceutical product registration
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Development of common technical dossier (CTD)
towards MRA
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Implementation of harmonized ASEAN
Pharmaceutical Product Dossier
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Impact of Harmonization
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Public Health
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Patients & Consumers
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Improve access & availability
Industry
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Improve Quality, Safety & Efficacy
Increase standards; compliance to GMP, GSP,
GCP, GLP
Regulatory
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Confidence building & mutual understanding
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PPWG Meetings
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Sept 1999, Kuala Lumpur
Mar 2000, Bangkok
Feb 2001, Ho Chi Minh
City
Sept 2001, Bali
Feb 2002, Yangon
Sept 2002, Siem Reap
Jul 2003, Penang
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Jul 2004, Bangkok
Feb 2005, Manila
Aug 2005, Singapore
Mar 2006, Hanoi
Nov 2006, Jakarta
Jul 2007, Kuala Lumpur
Feb 2008, Vientiane
Jul 2008, Brunei Darussalam
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The Technical Cooperation
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ACTR/ACTD on Quality – Indonesia
ACTR/ACTD on Safety – Philippines
ACTR/ACTD on Efficacy – Thailand
ACTR/ACTD on Administrative Data, Product
Information and Glossary – Malaysia
Guidelines on Analytical Validation – Thailand
Guidelines on Process Validation - Singapore
Guidelines on Stability Studies – Indonesia
Guidelines on BA/BE Studies - Malaysia
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ASEAN Healthcare Integration
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Healthcare is one of eleven priority sectors identified for
fast-tracked integration.
Roadmap related to pharmaceuticals:
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Study feasibility of an ASEAN MRA for pharmaceutical products
Implement ASEAN Common Technical Dossier (ACTD)
Harmonise labelling standards
Explore feasibility of adopting a harmonised placement system for
pharmaceutical products
Facilitate approval process after full implementation of the ACTD
Explore the feasibility of twinning systems to enhance regulatory
capacity and resource development
Formalise a post-marketing alert system for defective and unsafe
pharmaceutical products
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The PPWG – Current Status
1. Harmonisation of Key Areas 
agreed !
2. Harmonisation of Format for ACTR & ACTD  agreed !
3. Content of ACTR / ACTD / Glossary of Term  agreed !
4. Harmonisation of ACTR/ACTD  completed !
5. Implementation -Trial period  Sep.2003 onwards
6. Full Implementation  by 31 Dec. 2008
7. Implementation Working Group Created
Harmonization Milestones
1999
2002
2005
PPWG
IWG
GMP
MRA
TF
2006 2008 2009
BA/ GMP ACTD
BE MRA Implementation
TF
JSC
ACTD development
ACTR & technical guidelines
development
Regulatory capacity building
Post-Market Alert System
development
GMP Inspection MRA development
Training scheme development
ACTD implemented
ACTR & technical guidelines
established (maintenance and
enhancement of common interpretation
ongoing)
Post-Market Alert System established
GMP Inspection MRA to be signed
Pan-ASEAN registration
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Recent Developments in Economic
Integration
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AEC Blueprint
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ASEAN Trade in Goods Agreement (ATIGA)
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AEC Scorecard
AEC Communication Plan
Final draft of ATIGA on Standards, Technical Regulations
& Conformity Assessment Procedure
ASEAN Charter
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Brunei Darussalam, Cambodia, Lao PDR, Malaysia,
Myanmar, Singapore & Viet Nam have ratified
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Progress – 15th PPWG
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10th IWG
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Mechanism for revision of ATG
Impact Assessment Study
ASEAN Guidelines on Variation (Malaysia)
ASEAN Sectoral MRA on GMP Inspection of
Manufacturers of Medicinal Products
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Draft finalised (Version 4)
Enter into force upon signing
Deferral of implementation
ASEAN Summit, End 2008
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Updates – 15th PPWG
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ASEAN BA/BE Taskforce
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Framework for MRA of BA/BE Study Report
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ASEAN BE study reporting format
Conformance standards on clinical & bioanalytical
aspects of BE
Acceptable criteria for inspection on BA/BE
Cooperation with WHO
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Vaccine chapter
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Capacity building
ASEAN Expert Review Committee
Module 2 (ICH) Efficacy & Safety
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Cont Updates – 15th PPWG
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Combating counterfeit drugs
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Cooperation with ICH GCG
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1st ASEAN-China Conference on Combating Counterfeit
Drugs, Jakarta, Nov 2007
Operation Storm
SPOC network system
Regional Harmonisation Initiative (RHI) profile
ASEAN-US Cooperation on Pharmaceuticals
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US Technical Assistance & Training Facility
Country specific technical assistance
Training on GMP & BA/BE
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Other Matters – 15th PPWG
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ASEAN Regulatory Science Training
Accreditation Scheme
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Training the Trainers – Philippines
Revised ToR of PPWG
New role as JSC
APRIA – ASEAN entity
New Areas
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Biologicals including biotechnology
New integration initiative
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Key Issues
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Political situation
Regulatory infrastructure
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Legal, physical, financial
Human resource
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Capacity & capability
Gaps
Implementation
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Country specific requirements
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Understanding & interpretation
Variations
Industry involvement
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Technical discussion groups
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Current Focus
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New structure of PPWG
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APC & APRIA involvements
Monitoring of Implementation of ACTD &
Technical Guidelines
Sectoral MRA on GMP Inspections
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JSC
Date enter into force
Sectoral MRA on BA/BE studies
Structured training schemes
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Future Direction ?
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ACTD non-binding
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Future initiative for integration of Pharmaceutical
Sector
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ASEAN Pharmaceutical Directives
Biotechnology – biologicals, vaccines
Harmonized placement system for
pharmaceutical products into ASEAN market
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Pan ASEAN Registration
Common Procedure
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Challenges
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Political uncertainty
Economic downturn
Trade negotiations – FTA
Disparity in legal framework
Public health issues
Global competition
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Conclusion
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Trade globalization has prompted the need for strategic
partnership. Harmonized standards are important in
facilitating and liberalizing trade and investment.
Regional harmonization can only be achieved by bridging
the gaps between ASEAN member countries in the
establishment of regulatory systems and implementation of
common requirements.
Global co-operation provides opportunities for development
and improvements, paving the way for international
recognition. Establishing MRA is crucial to ensure effective
harmonization.
Despite challenges, PPWG will move forward towards
creating a single pharmaceutical market.
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