ASEAN Regional Integration Support from the EU

ASEAN Agrees on Common Requirements of Biological Products

The ASEAN Coordinating Committee on Standards and Quality Pharmaceutical Products Working Group (PPWG) agreed on two sets of new ASEAN Common Technical Requirements of biological products during a workshop held in Jakarta on 22- 24 May.

Those two sets of requirements are ASEAN Common Technical Requirements (ACTR) on quality and ACTR on safety and efficacy of biological products.

Since the formation of above working group in 1999, the group has made significant advances in developing harmonised technical requirements for pharmaceutical regulation. These newly developed sets of requirements on quality and safety and efficacy of biological products, including vaccine and biotech products, are the first results of the expansion of scope of work of the working group from chemical products to include products from biotechnology processes.

In her closing remarks, Dr. Ir. Penny K. Lukito, Chairperson of Indonesia National Agency of Drug and Food Control, attributed the success of the workshop to the concrete collaboration among regulators of the ASEAN Secretariat, Member States and industries in developing harmonised drug registration requirements and standards in the region.

The chairperson also expressed her hope that once completed, the two new ACTRs would contribute positively to the harmonisation in the area of pharmaceutical and biological products in the ASEAN region. She also expressed her appreciation for the support extended by the EU ARISE Plus project to sponsor this workshop which was attended by 37 participants comprising of representatives from all ten ASEAN Member States, the ASEAN Pharmaceutical Research Industry Association and the ASEAN Pharmaceutical Club.

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