The adoption of the jointly developed ASEAN Pharmaceutical Regulatory Policy (APRP) by the ASEAN Health Ministers and ASEAN Economic Ministers marks a new milestone in working towards the longer-term target to establish and adopt a common policy that provides a basis for structuring regulatory systems for pharmaceutical products across ASEAN.
This will not only enable the reduction of trade barriers and enhance harmonisation of regulatory requirements and collaboration between regulators but also to ensure timely access to high quality, safe and efficacious pharmaceutical products.
The APRP has been developed by ASEAN Member States (AMS) with the support of the EU funded ARISE Plus project. It has been a collaborative effort of officials representing the Health and Economic Sectors and is a significant step milestone in realising the vision for the market integration of the pharmaceutical sector in ASEAN.
The APRP addresses aspects concerned with quality, safety, efficacy and availability of pharmaceuticals from both the health and trade perspectives. It provides guiding principles that will apply to approval and recognition arrangements, harmonisation of regulatory requirements and practices by governmental institutions and associated supporting mechanisms of AMS, for human pharmaceutical products placed on AMS’ market.
The scope of the APRP includes pharmaceutical products such as, vaccines, antidotes, and other critical or life-saving pharmaceuticals, and all activities related to the development, testing, manufacture and distribution of these products.
The APRP’s guiding principles on pharmaceutical regulation provide direction for future integration of the sector and are applicable to regulations across the entire life-cycle of pharmaceutical products to support the healthcare systems as well as to protect the health of populations in ASEAN.
ASEAN Health and Economic Sectors officials are currently engaged in a final stage of discussions for establishment the ASEAN Pharmaceutical Regulatory Framework (APRF) that will supplement the APRP by providing a common reference for implementation of its principles.
The adoption of the APRP has set the basis for stepwise expansion of cooperation and recognition and facilitated initial work on the development of a legal instrument for implementation of APRF, as well as the development of a series of subsidiary instruments for the ASEAN sectoral bodies involved in pharmaceutical priorities sector.
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