Adoption of the Association of Southeast Asian Nations (ASEAN) Common Technial Dossier (ACTD) and Common Technical Requirements (ACTR) for the Registration of Pharmaceutical Products for Human Use

I. Background

The ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed by the ASEAN Economic Ministry in 1992 with the aim of eliminating technical barriers to trade of goods and services in order to facilitate the implementation of the Agreement on the Common Effective Preferential Tariff (CEPT) Scheme and realize the ASEAN Free Trade Area (AFTA) by 2015.

The 13th Meeting of the ACSQ held in Manila in 1999 agreed that a Pharmaceutical Product Working Group (PPWG) be set up to develop harmonized schemes in pharmaceutical product regulation among the 10 ASEAN Member States to complement the objective of AFTA without compromising quality, safety and efficacy of pharmaceutical products made available.

Given the significant differences in the existing infrastructure and technical and financial capacity of ASEAN Member States, the PPWG was able to make considerable progress through the years.  After series of meetings and consultations among the national drug regulatory authorities and pharmaceutical industries of the region, the PPWG was able to establish and adopt the ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR).  Both the ACTD and ACTR are currently in various stages of implementation among ASEAN Members States.


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