ASEAN Regional Integration Support from the EU

The ASEAN Pharmaceutical Product Working Group (PPWG) Develops ASEAN Common Technical Requirements (ACTR) for Biotechnological Products

ARISE Plus continues to extend its support to ASEAN to develop a robust regulatory framework to ensure the availability of safe, effective and high-quality medicinal products in the region in line with ASEAN Post 2015 Health Development Agenda. One of the instruments identified to achieve this aim is the ASEAN Common Technical Requirements (ACTR). These add to the existing collection of ACTR and help to enhance cooperation and harmonization of regulatory requirements in the pharmaceutical sector within ASEAN Member States.

In furtherance of this initiative a workshop of Technical Working Group (TWG) Biologics on ACTR for Quality and ACTR for Safety and Efficacy was held on the 22 – 24 May 2018 in Jakarta Indonesia. The objective of the workshop was to finalize the proposed revision to the two mentioned ACTR. The three-day workshop was made up of productive presentations, discussions and recommendations among the participants.

The three-day workshop led to the development of the final drafts of ACTR for Safety and Efficacy, Rev. 1 and ACTR for Quality. The TWG will review these drafts and seek endorsement of the PPWG during the 25th PPWG Meeting to be held in Danang, Viet Nam on August 6-10, 2018.

Support provided to the ASEAN pharmaceutical sector will serve as a conduit towards the adoption of a common approach for pharmaceutical regulation in turn facilitating the production of pharmaceuticals and improving access to quality and affordable medicines for the ASEAN community.

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