ASEAN Regional Integration Support from the EU

Workshop on the ASEAN Pharmaceutical Regulatory Policy and the ASEAN Pharmaceutical Regulatory Framework (APRP and APRF)

ARISE Plus organised a third Workshop on ASEAN Pharmaceutical Regulatory Policy (APRP) and the associated ASEAN Pharmaceutical Regulatory Framework (APRF). The virtual event held on August 4th and 5th 2021,  brought  representatives from the  ASEAN Pharmaceutical Products Working Group (PPWG) and ASEAN Health Cluster 3 (AHC 3) together to  continue deliberations on the text of an ASEAN Pharmaceutical Regulatory Policy (APRP) and on the outline of  the associated ASEAN Pharmaceutical Regulatory Framework( APRF). Officials from ASEAN Member States representing pharmaceutical regulators health officials made significant progress following up from the second workshop, held on June 7th & 8th  2021.    

The workshop participants achieved substantial consensus towards finalising the text of an ASEAN Pharmaceutical Regulatory Policy (APRP) and are expected to finalise the draft upon resolution of  one remaining article. It is planned to seek endorsement of ASEAN Senior Officials of the Economic and Health Development divisions as soon as the PPWG and AHC 3 resolve concerns on the remaining Article. In addition substantial consensus was also reached, through the deliberations on the ASEAN Pharmaceutical Regulatory Framework(APRF) and there was agreement that a final draft would be available by end of 2021 for Member States internal review.

The workshop participants further agreed on the practical arrangements leading to the development of the APRF Framework Agreement. The participants held discussions and agreed to propose  the establishment a task force that will undertake the drafting of APRF Agreement and proposed the  terms of reference for the task force.  

The adoption of 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.  The adoption of the APRF Agreement will be a major milestone in the ambitious longer term target to establish and adopt a common policy that when adopted will provide a reference to structure the regulatory systems for  pharmaceutical products in a harmonised  manner across ASEAN. It is intended that the scope of the framework will encompass the completed life cycle of pharmaceutical products.  The Agreement will provide the basis for transforming the currently voluntary harmonised  standards and the associated technical requirements into obligations for Member States thus ensuring an effective integration of the market and removal of unnecessary trade barriers.

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