ASEAN develops new common requirements for biological products

ASEAN develops new common requirements for biological products


The ASEAN Coordinating Committee on Standards and Quality Pharmaceutical Products Working Group (PPWG) have agreed on two sets of new ASEAN Common Technical Requirements (ACTR) for biological products.

These two sets of requirements are the ACTR on quality and ACTR on safety and efficacy of biological products.

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 expanded scope of work of the working group, whose focus has been enlarged from chemical products to include products from biotechnology processes.

Since the PPWG was formed in 1999, the group has made significant advances in developing harmonized technical requirements for pharmaceutical regulation.

Dr. Ir. Penny K. Lukito, chairperson of Indonesia National Agency of Drug and Food Control, attributed the success of the workshop held May 22 to May 24 to the “concrete collaboration among regulators of the ASEAN Secretariat, member states and industries in developing harmonized drug registration requirements and standards in the region.”

The chairperson also expressed her hope that once completed, the two new ACTRs would contribute to the harmonization in the area of pharmaceutical and biological products in the ASEAN region.

Photo: Daniel Paquet


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