Asean agrees on pharmaceutical regulatory policy towards market integration
JAKARTA - The Asean Health Ministers and Economic Ministers have adopted the jointly developed Asean Pharmaceutical Regulatory Policy (APRP) that provides a basis for structuring regulatory systems for pharmaceutical products across the region.
The adoption of the policy will enable the reduction of trade barriers and enhance harmonisation of regulatory requirements and regulators' collaboration as well as ensuring timely access to high quality, safe and efficacious pharmaceutical products.
"The APRP 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 Asean Secretariat said in a statement published on its website.
The policy 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 Asean member states, for human pharmaceutical products placed on the 10-member regional grouping market.
The APRP includes pharmaceutical products such as vaccines, antidotes, and other critical or life-saving pharmaceuticals, as well as product development, testing, manufacture, and distribution.
In another development, officials of Asean Health and Economic Sectors are currently engaged in the final stage of discussions for the establishment of the Asean Pharmaceutical Regulatory Framework.
This will supplement the APRP by providing a common reference for implementation of its principles, the secretariat said. - BERNAMA
