1. ASEAN Pharmaceutical Harmonization
Selvaraja Seerangam
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
V Conference of PANDRH 2008
17-19 November 2008, Argentina

2. Presentation Outline About ASEAN Background Economic Integration
Current Status
Issues & Challenges
Conclusion

3. ASEAN MAP

4. History
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

5. Facts ASEAN region has a population of about 560 million
Combined gross domestic product almost US$ 1,100 billion
Total trade of about US$ 1,400 billion

6. ASEAN- The Goal ASEAN Economic Community (AEC)
ASEAN Summit
ASEAN Economic Community (AEC)
“by the year 2015….. ASEAN will be
A Single Market and A Single Production Base”
Free flow of Goods
Free flow of Services
Free flow of Investment
Free flow of Capitals
Free flow of Skilled Labour

7. ASEAN Free Trade Area (AFTA)
AFTA is a collective effort by ASEAN to reduce/eliminate tariffs in intra-ASEAN trade in the goods sector.
Objective of AFTA is primarily to enhance ASEAN’s position as a competitive production base for regional and global markets

8. ACCSQ- to facilitate AFTA
The ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed in by Senior Economic Official Meeting (SEOM) to facilitate and complement the ASEAN Free Trade Area (AFTA).
Concept of ASEAN pharmaceutical harmonization was presented by Malaysia and agreed upon by the Senior Economic Officials Meeting (SEOM) in 1999.
The Pharmaceutical Product Working Group (PPWG) was formed in Malaysia hosted the 1st PPWG meeting and was appointed the Chair and Thailand the Co-Chair.

9. ACCSQ Agenda
Facilitation of the realization of the ASEAN economic community
Working Groups and Product Working Groups
Cooperation with dialogue partners and other organizations on standards and conformance
ACCSQ-PPWG 9

10. Economic Cooperation ASEAN Summit AEM SEOM ACCSQ -Formed in 1992 WGs
PWGs
WG 1 on MRAs & Standards –
WG 2 on on Accreditation and Conformity Assessment –
WG 3 Legal Metrology –
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) 12

11. Objective of Pharmaceutical Product Working Group (PPWG)
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.

12. Scope of PPWG
Exchange of information on existing requirements and regulations
Review requirements and regulations, and conduct comparative studies
Study other harmonized procedures and regulatory system
Develop technical requirements
Establish common technical documents towards achieving MRA

13. Strategies
Comparison of existing product registration requirements for pharmaceuticals
Development of common technical requirements (CTR) for pharmaceutical product registration
Development of common technical dossier (CTD) towards MRA
Implementation of harmonized ASEAN Pharmaceutical Product Dossier

14. Impact of Harmonization
Public Health
Improve Quality, Safety & Efficacy
Patients & Consumers
Improve access & availability
Industry
Increase standards; compliance to GMP, GSP, GCP, GLP
Regulatory
Confidence building & mutual understanding

15. PPWG Meetings 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
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

16. The Technical Cooperation
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

17. ASEAN Healthcare Integration
Healthcare is one of eleven priority sectors identified for fast-tracked integration.
Roadmap related to pharmaceuticals:
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

18. 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

19. Harmonization Milestones
1999
2002
2005
2006
2008
2009
PPWG
IWG
GMP MRA TF
BA/ BE TF
GMP MRA
ACTD Implementation
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

20. Recent Developments in Economic Integration
AEC Blueprint
AEC Scorecard
AEC Communication Plan
ASEAN Trade in Goods Agreement (ATIGA)
Final draft of ATIGA on Standards, Technical Regulations & Conformity Assessment Procedure
ASEAN Charter
Brunei Darussalam, Cambodia, Lao PDR, Malaysia, Myanmar, Singapore & Viet Nam have ratified

21. Progress – 15th PPWG 10th IWG
Mechanism for revision of ATG
Impact Assessment Study
ASEAN Guidelines on Variation (Malaysia)
ASEAN Sectoral MRA on GMP Inspection of Manufacturers of Medicinal Products
Draft finalised (Version 4)
Enter into force upon signing
Deferral of implementation
ASEAN Summit, End 2008

22. Updates – 15th PPWG ASEAN BA/BE Taskforce Cooperation with WHO
Framework for MRA of BA/BE Study Report
ASEAN BE study reporting format
Conformance standards on clinical & bioanalytical aspects of BE
Acceptable criteria for inspection on BA/BE
Cooperation with WHO
Vaccine chapter
Capacity building
ASEAN Expert Review Committee
Module 2 (ICH) Efficacy & Safety

23. Cont Updates – 15th PPWG Cooperation with ICH GCG
Combating counterfeit drugs
1st ASEAN-China Conference on Combating Counterfeit Drugs, Jakarta, Nov 2007
Operation Storm
SPOC network system
Cooperation with ICH GCG
Regional Harmonisation Initiative (RHI) profile
ASEAN-US Cooperation on Pharmaceuticals
US Technical Assistance & Training Facility
Country specific technical assistance
Training on GMP & BA/BE

24. Other Matters – 15th PPWG
ASEAN Regulatory Science Training Accreditation Scheme
Training the Trainers – Philippines
Revised ToR of PPWG
New role as JSC
APRIA – ASEAN entity
New Areas
Biologicals including biotechnology
New integration initiative

25. Key Issues Political situation Regulatory infrastructure
Legal, physical, financial
Human resource
Capacity & capability
Gaps
Implementation
Understanding & interpretation
Country specific requirements
Variations
Industry involvement
Technical discussion groups

26. Current Focus New structure of PPWG APC & APRIA involvements
JSC
APC & APRIA involvements
Monitoring of Implementation of ACTD & Technical Guidelines
Sectoral MRA on GMP Inspections
Date enter into force
Sectoral MRA on BA/BE studies
Structured training schemes

27. Future Direction ? ACTD non-binding
ASEAN Pharmaceutical Directives
Future initiative for integration of Pharmaceutical Sector
Biotechnology – biologicals, vaccines
Harmonized placement system for pharmaceutical products into ASEAN market
Pan ASEAN Registration
Common Procedure

28. Challenges Political uncertainty Economic downturn
Trade negotiations – FTA
Disparity in legal framework
Public health issues
Global competition

29. Conclusion
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.

30. Thank You