ASEAN Regional Integration Support from the EU

ASEAN Pharmaceutical Regulatory Framework – Principles and Outline

ARISE Plus organised a workshop to discuss ASEAN Pharmaceutical Regulatory Framework (APRF) on 7th March 2022 for representatives of the Pharmaceutical Product Working Group (PPWG) and the ASEAN Health Cluster 3 (AHC 3).

The workshop was a follow up to previous discussions and has resulted in the preparation of a final draft of the APRF by the project. which  was only possible after a full review of  comments and inputs from AHC 3 and PPWG Members. The APRF will now be submitted for endorsement by  ASEAN senior officials prior to adoption by ASEAN Ministers.

The adoption of the APRF, together with the ASEAN Pharmaceutical Regulatory Policy (APRP), which has been submitted for adoption, concludes the preparatory steps for the development of a legally binding ASEAN Pharmaceutical Regulatory Framework Agreement (APRF Agreement).

Work on the development of the APRF agreement will now actively commence. ASEAN Member States have established the APRF Agreement Task Force with representatives from all Member States to undertake this work. The Task Force is now commencing deliberations with the first formal meeting scheduled for later this month. 

The APRF Agreement will provide a structured approach to link the various initiatives and instruments that have been developed by the PPWG and AHC 3 on the safety, quality, efficacy and use of pharmaceutical products and set the basis for stepwise expansion of cooperation and recognition across the life-cycle of pharmaceutical products and the development of a series of subsidiary instruments. 

Back to Top