ASEAN Regional Integration Support from the EU

ASEAN Pharmaceutical Regulatory Framework (APRF)

ARISE Plus carried out a further workshop to finalise ASEAN Pharmaceutical Regulatory Framework (APRF) on 21 June 2022 to address the last remaining issues from the previous workshop held on 7th March 2022.

The ASEAN experts representing the Pharmaceutical Product Working Group (PPWG) and the ASEAN Health Cluster 3 (AHC 3) successfully resolved all outstanding concerns and agreement was reached that the version developed during the workshop should be forwarded for endorsement by the  AHC 3 and PPWG.

The adoption of the APRF, together with the ASEAN Pharmaceutical Regulatory Policy (APRP) which has been now been adopted by the ASEAN Economic and Health Ministers concludes the preparatory stages for the development of the ASEAN Pharmaceutical Regulatory Framework Agreement (APRF Agreement).

The APRP provides the agreed principles for regulatory cooperation and while the APRF outlines the approach and overall structure of the framework to be developed to integrate the ASEAN Pharmaceutical sector.

The APRF Agreement provides a structured regulatory approach to link the various initiatives and instruments that have been developed by the PPWG and AHC3 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 through the development of a series of subsidiary instruments.

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