ASEAN Pharmaceutical Harmonization

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 Summit ASEAN Economic Community (AEC) “by the year 2015….. ASEAN will be A Single Market andA 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 1992 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 1999. 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 9 ACCSQ-PPWG

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 3Legal Metrology – • ACC (ASEAN Committee on Cosmetic) • PPWG (Pharmaceuticals PWG) • EE PWG (Electrical and Electronic PWG) • Pf PWG (Prepared Foodstuff PWG) • TMHSPWG (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. 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 PPWG Meetings

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. 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 The PPWG – Current Status 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 • 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 • 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 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