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

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

About ASEAN Background Economic Integration Current Status Issues & Challenges Conclusion

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ASEAN MAP

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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

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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

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ASEAN Summit

ASEAN- The Goal

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

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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.

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ACCSQ-PPWG 9

ACCSQ Agenda

Facilitation of the realization of the ASEAN Facilitation of the realization of the ASEAN economic communityeconomic community

Working Groups and Product Working Working Groups and Product Working GroupsGroups

Cooperation with dialogue partners and other Cooperation with dialogue partners and other organizations on standards and conformanceorganizations on standards and conformance

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ASEAN Summit

AEM

SEOM

ACCSQ -Formed in 1992

WGs PWGsWG 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)

Economic Cooperation

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.

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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

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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

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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

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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

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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

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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

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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

The PPWG – Current Status

7. Implementation Working Group Created

Harmonization Milestones

1999 2005 2006 20092002

PPWG IWG BA/ BE TF

GMP MRA TF

ACTD implementedACTR & technical guidelines established (maintenance and enhancement of common interpretation ongoing)Post-Market Alert System established

GMP Inspection MRA to be signed

Pan-ASEAN registration

ACTD developmentACTR & technical guidelines developmentRegulatory capacity buildingPost-Market Alert System developmentGMP Inspection MRA developmentTraining scheme development

ACTD Implementation

JSC

2008

GMP MRA

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Recent Developments in Economic Integration AEC BlueprintAEC Blueprint

AEC ScorecardAEC Scorecard AEC Communication Plan AEC Communication Plan

ASEAN Trade in Goods Agreement (ATIGA)ASEAN Trade in Goods Agreement (ATIGA) Final draft of ATIGA on Standards, Technical Regulations Final draft of ATIGA on Standards, Technical Regulations

& Conformity Assessment Procedure& Conformity Assessment Procedure

ASEAN CharterASEAN Charter Brunei Darussalam, Cambodia, Lao PDR, Malaysia, Brunei Darussalam, Cambodia, Lao PDR, Malaysia,

Myanmar, Singapore & Viet Nam have ratifiedMyanmar, Singapore & Viet Nam have ratified

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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

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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

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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

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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

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Key Issues Political situationPolitical situation Regulatory infrastructure Regulatory infrastructure

Legal, physical, financial Legal, physical, financial Human resource Human resource

Capacity & capabilityCapacity & capability GapsGaps

Implementation Implementation Understanding & interpretationUnderstanding & interpretation

Country specific requirementsCountry specific requirements VariationsVariations

Industry involvement Industry involvement Technical discussion groupsTechnical discussion groups

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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

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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

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Challenges

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

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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.

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