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

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

ASEAN MAP

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

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

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

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

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.

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

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

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.

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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.

Thank You