New Asean requirements on biological products

BANDAR SERI BEGAWAN — Countries in the region recently agreed to two sets of new Asean Common Technical Requirements on biological products.

According to a press release, the Asean Coordinating Committee on Standards and Quality Pharmaceutical Products Working Group (PPWG) agreed on two sets of new Asean Common Technical Requirements on biological products during a workshop in Jakarta on May 22-24.

The workshop was attended by 37 participants comprising representatives from all 10 ASEAN member states, the Asean Pharmaceutical Research Industry Association and the Asean Pharmaceutical Club.

The two sets of requirements are Asean Common Technical Requirements (ACTRs) on quality and ACTR on safety and efficacy of biological products.

The press release noted that since the formation of above working group in 1999, the group has made significant advances in developing harmonized technical requirements for pharmaceutical regulation.

These new sets of requirements on quality and safety and efficacy on 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.

The press release stated that Dr Ir Penny K Lukito, Chairperson of Indonesia National Agency of Drug and Food Control delivered closing remarks, in which she attributed the success of the workshop to the concrete collaboration among regulators of the Asean Secretariat, member states and industries.

The chairperson expressed hope that once completed, the two ACTRs would contribute positively to the harmonisation in the area of pharmaceutical and biological products in the Asean region.

Additionally, she expressed her appreciation for the support extended by the EU ARISE Plus project to sponsor the workshop.