Adoption of the International Conference on Harmonization (ICH) Safety and Efficacy Guidelines

Pursuant to Administrative Order No. 2013-0021 known as the "Adoption of the Association of Southeast Asian Nations (ASEAN) Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for the Registration of Pharmaceutical Products for Human Use," enhancing public health and welfare by providing faster access to and increasing availability of quality, safe, and efficacious pharmaceutical products has been promulgated.

The ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group (ACCSQ-PPWG), comprised of delegates and observers from the drug regulatory authorities and pharmaceutical industry associations of the 10 Members States, has for years been taking the lead role in developing efficient schemes to harmonize pharmaceutical regulations across the Southeast Asian region with the aim of eliminating technical barriers to trade posed by such regulations, and realize the ASEAN Free Traded Area (AFTA) by 2015.

At its 20th Meeting held in Bali, Indonesia last May 2013, the ACCSQ-PPWG endorsed the adoption of selected International Conference on Harmonization(ICH) Safety and Efficacy Guidelines.  The Philippines and Thailand, as the lead countries for Safety and Efficacy guidelines, respectively, presented the updated list of ICH Guidelines that ASEAN considers for adoption based on the following criteria:

(a)  ICH guidelines that have reached step 5 and implemented by all three regions will be considered for adoption as ASEAN Guidelines on Safety and/or Efficacy; and

(b)  ICH guidelines that have reached step 5 but have not yet been implemented by all 3 member countries/regions shall be considered as reference only



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