ASEAN Regional Integration Support from the EU

First Workshop – ASEAN Pharmaceutical Regulatory Framework Agreement (APRF)

The ASEAN Pharmaceutical Regulatory Framework Task Force (APRF Task Force) was established by ASEAN Member States to undertake the development of the ASEAN Pharmaceutical Regulatory Framework Agreement and comprises the ASEAN Pharmaceutical Product Working Group (PPWG) and the ASEAN Health Cluster 3 (AHC3) Strengthening Health Systems and Access to Care

This specially established Task Force commenced its deliberations on developing this ASEAN Agreement that will encompass the ASEAN Pharmaceutical Regulatory Policy (APRP) and ASEAN Pharmaceutical Regulatory Framework (APRF) and enable implementation in all Member States. 

During the 2 day workshop the Task Force Members reviewed a preliminary draft agreement that had been developed with the assistance of ARISE Plus and made recommendations that would be considered in the development of the first official draft of the APRF Agreement.

The APRF Agreement provides a structured approach that will link the existing initiatives and instruments on the regulation and use and pharmaceutical products in ASEAN that have been developed by PPWG and AHC 3. The Agreement establishes a base for a stepwise expansion of cooperation and recognition of regulatory decisions across the life cycle of pharmaceutical products. 

The Task Force Members will now further study and comment on the issues identified during the workshop and ARISE Plus will continue to support the development of a more substantive first draft agreement based on inputs received to facilitate on-going deliberations.


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