Illustrative image (Source: asean.org) The adoption marks a new milestone in working towards the longer-term target toestablish and adopt a common policy that provides a basis for structuringregulatory systems for pharmaceutical products across ASEAN, according to theASEAN Secretariat.
This will not only enable the reduction of trade barriers and enhanceharmonisation of regulatory requirements and collaboration between regulatorsbut also to ensure timely access to high quality, safe and efficaciouspharmaceutical products.
The APRP has been developed by ASEAN member state with the support of the EUfunded ARISE Plus project. It has been a collaborative effort of officialsrepresenting the Health and Economic Sectors and is a significant stepmilestone in realising the vision for the market integration of thepharmaceutical sector in ASEAN.
The APRP addresses aspects concerned with quality, safety, efficacy andavailability of pharmaceuticals from both the health and trade perspectives. Itprovides guiding principles that will apply to approval and recognitionarrangements, harmonisation of regulatory requirements and practices bygovernmental institutions and associated supporting mechanisms of ASEANcountries, for human pharmaceutical products placed on the regional market.
The scope of the APRP includes pharmaceutical products such as, vaccines,antidotes, and other critical or life-saving pharmaceuticals, and allactivities related to the development, testing, manufacture and distribution ofthese products.
The APRP’s guiding principles on pharmaceutical regulation provide directionfor future integration of the sector and are applicable to regulations acrossthe entire life-cycle of pharmaceutical products to support the healthcaresystems as well as to protect the health of populations in ASEAN.
ASEAN health and economic sectors’ officials are currently engaged in a finalstage of discussions for establishment the ASEAN Pharmaceutical RegulatoryFramework (APRF) that will supplement the APRP by providing a common referencefor implementation of its principles.
The adoption of the APRP has set the basis for stepwise expansion ofcooperation and recognition and facilitated initial work on the development ofa legal instrument for implementation of APRF, as well as the development of aseries of subsidiary instruments for the ASEAN sectoral bodies involved inpharmaceutical priorities sector./.
VNA
