ASEAN Regional Integration Support from the EU

Discussion on the ASEAN Pharmaceutical Regulatory Policy (APRP)

ARISE Plus organised 2 discussion sessions on ASEAN Pharmaceutical Regulatory Policy (APRP) for representatives of the Pharmaceutical Product Working Group(PPWG) and the ASEAN Health Cluster 3 (AHC 3). The two ASEAN bodies representing Member States’ interest in the economic and health aspects of the pharmaceutical sector are leading the development of comprehensive market integration of the pharmaceutical sector. The virtual event was held in 2 sessions on 8th & 15th October, 2021 to develop the draft APRP and propose this for formal adoption by ASEAN. This event was the 4th round of the of deliberations on the APRP and  have been ongoing since December 2020.

After extensive and serious discussions, the representatives of the PPWG  and the AHC 3 developed a consensus on the draft APRP and have proposed this to be progressed through the formal  process to be endorsed by the ASEAN Health and Economic Ministers.

The APRP is intended  to establish a consensus on the guiding principles for pharmaceutical regulation and on a  policy that provides direction for future development of the sector. It will  lead to the  initiation of work for the development of the ASEAN Pharmaceutical Regulatory Framework Agreement. The APRP a will serve as references in the drafting of the APRF Agreement together with the ASEAN Pharmaceutical Regulatory Framework (APRF) document, that is currently under development. The APRP and the APRF, which contains a broad description of the pharmaceutical regulatory framework, establish consensus between ASEAN bodies, and are  precursors to the APRF Agreement. The APRF Agreement will contain binding legal obligations for Member States that will lay the basis for the integration in the ASEAN Pharmaceutical Sector.

It is planned that upon adoption of the APRP,  discussions will commence on the development of APRF the agreement. 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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