Background

Efforts toward harmonization of ASEAN pharmaceutical regulations were initiated in 1992 through the ASEAN Consultative Committee for Standards and Quality (ACCSQ). The 13th Meeting of the ACCSQ held in March 1999 in Manila, agreed that a Product Working Group on Pharmaceutical (PPWG) be set up, with Malaysia as the lead country. Hence the formation of ACCSQ-PPWG in September 1999 in Kuala Lumpur, Malaysia.

Objective

The objective of the ACCSQ-PPWG is to develop harmonization schemes of pharmaceuticals’ regulations of the ASEAN member countries to complement and facilitate the objective of ASEAN Free Trade Area (AFTA), particularly, the elimination of technical barriers to trade posed by these regulations, without compromising on drug quality, safety and efficacy.

Summary of Achievements and Meeting Updates

The Meetings were attended by delegates and observers from all the ASEAN member countries, comprising of both regulatory and industry representatives. A staff of the ASEAN Secretariat and a representative from the World Health Organisation (WHO) were also in attendance.

First Meeting 6-7 September, 1999 in Kuala Lumpur , Malaysia

1.Terms of reference formulated
2. Workplan drawn: goals, strategies, activities, expected output and status.
3. Update on Common Effective Preferential Tariff (CEPT) Scheme for AFTA
4. Sharing of experience through presentation of country reports
5. Review of efforts towards international harmonization of regulatory requirements

Second Meeting 5-6 March, 2000 in Bangkok, Thailand

1. Review of reports of core activities
2. Update on Trend of Pharmaceutical Harmonisation
3. Formation of Ad-Hoc Committees on Quality, Safety (Pre-Clinical), Efficacy (Clinical Data) and Admistrative Data and Product Information with the respective lead countries Indonesia, Philippines, Thailand and Malaysia.
4. Designation of coordinating countries
5. Selection of specific areas for harmonization based on Safety, Quality, and Efficacy
Third Meeting 6-7 February, 2001 in Ho Chi Minh City, Vietnam

1. Plenary sessions of Ad-Hoc Committees
2. Drafting of ASEAN Common Technical Requirements (ACTRs)
3. Scientific and technical aspects deliberated : Pharmaceutics-Quality, Pharmacological/Toxicological Data-Safety, Clinical data-Efficacy and Administrative data and product information

Fourth Meeting 28-29 September, 2001 in Bali, Indonesia

1. Consideration of the ACTR and ASEAN Common Technical Dossier (ACTD) on Administrative data and product information – Malaysia
2. Consideration of the ACTR and ACTD on Quality – Indonesia
3. Consideration of the ACTR and ACTD on Safety – Philippines
4. Consideration of the ACTR and ACTD on Efficacy – Thailand
5. Consideration of ASEAN glossary – Malaysia
6. Revision of the work programme of ACCSQ-PPWG

Fifth Meeting 25-27 February, 2002 in Yangon, Myanmar

1. Consideration and confirmation of guidelines on ACTR- Quality, Safety (non-clinical study), Efficacy (clinical data) and Administrative data   and product information.
2. Consideration of the first draft of overall ACTD’s organization -Thailand
3 . Adoption of ACTR and first draft of ACTD together with the proposed ASEAN guidelines
4. Adoption of draft ASEAN glossary
5. Consideration of implementation issues of ACTD
6. Cooperation with international organizations and dialogue partners
7. Revision of the work programme of ACCSQ-PPWG

 

Sixth Meeting 4-6 Sptember, 2002 in Siem Reap, Cambodia

1.The meeting was preceeded by the Technical Meeting of PPWG on product information and stability
2.Adoption of final draft of ASEAN glossary
3. Adoption of the final drafts of ACTRs, ACTD on safety, efficacy and administrative data and product information
4. Consideration of ACTD’s organization and proposal to compare it with ICH CTD
5. Agreement of first draft of working guidelines namely :
-Draft Guidelines on Stability Studies-Indonesia
        -Draft Guidelines on Analytical Validation-Thailand
-Draft Guidelines on Process Validation-Singapore
-Draft Guidelines on Bioavailability and   Bioequivalence (BA/BE) Studies-Malaysia
6. Formation of Implementation Working group (IWG) – comprising of the following members ; Singapore as Chair , Indonesia as Co-chair, Malaysia, Philippines and Thailand – in view of the implementation of the ACTD in 2003
7. Cooperation with international organizations and dialogue partners :

 

(i) WHO-ASEAN Harmonization project, (ii) ACCSQ-US Coorperation – with three PPWG project proposals ;(i) Developing the Guidelines on Quality, (ii) Training on Clinical Data and(iii) Developing and Implementing the “Guideline & Implementation SOP” of an ASEAN Bridging Study Requirement
8. Revision of the work programme of ACCSQ-PPWG which has been expanded to cover the new goals : Implementation of the harmonized ASEAN Documents and looking into the possible “Sectoral MRA”.
Conclusion

Overall, the ACCSQ-PPWG has made considerable progress, despite limitations in the existing capability and capacity of the Regulatory Authorities of ASEAN member countries. Due to varying readiness expressed by some member countries to conform to the harmonized requirements a transition period of two years is provided. The coordinating and monitoring activities as well as other assistance will be under the purview of the IWG.

The Seventh Meeting of the ACCSQ-PPWG will be held in early July 2003 in Malaysia.