ASEAN Member States have crossed a significant milestone on their quest to establish a harmonised regulatory regime in ASEAN for pharmaceuticals. The adoption of the ASEAN Pharmaceutical Regulatory Framework (APRF) on 31 March 2023, and 5 April 2023 by the ASEAN Health Ministers and the ASEAN Economic Ministers, respectively, paves the way for the continuing efforts for realisation of an arrangement in ASEAN that will include harmonised regulatory requirements for pharmaceutical registration, mutual recognition and other regulatory processes facilitating movement pharmaceutical products between ASEAN Member States. This initiative directly supports ASEAN’s objectives of eliminating unnecessary technical trade barriers for trade in pharmaceutical product and enhancing access to safe quality and efficacious medicines.
The adoption of the APRF is the culmination of protracted efforts by officials from ASEAN Member States represented in the ASEAN Pharmaceutical Product Working Group (PPWG) under economic pillar and ASEAN Health Cluster 3 (AHC 3) under socio-cultural pillar with the close support of ARISE Plus. The adoption of the APRF is a follow-up to the adoption of the ASEAN Pharmaceutical Regulatory Policy (APRP) in 2022. The APRP has defined ASEAN principles for regulatory cooperation while the APRF defines approach and structure of the overall framework to integrate the ASEAN pharmaceutical sector.
As next step, the ASEAN Member States’ Officials representing the health and economic sectors have been working in parallel, with the support of ARISE Plus, to finalise the ASEAN Pharmaceutical Regulatory Framework Agreement (APRF Agreement). The draft APRF agreement is now in the final stages of completion. The Agreement will provide the legal basis for the operation of the APRF that entails cooperation and recognition across the life-cycle of pharmaceutical products. It is intended to provide a structured approach to link the various initiatives and instruments on the safety, quality, efficacy and use of pharmaceutical products that have been previously developed by the PPWG and AHC3. The APRF Agreement will set the basis for stepwise expansion of cooperation and recognition across the life-cycle of pharmaceutical products through the development of a series of subsidiary instruments.
