Report of the Ninth Asian National Control Laboratory Network meeting in 2024, with a focus on regional harmonization of regulatory systems to prepare for cross-border transfer of plasma

Abstract

The National Institute of Food and Drug Safety Evaluation, under the Ministry of Food and Drug Safety in Korea, organized and hosted the 2024 Asian National Control Laboratory (NCL) Network meeting which focussed on regional harmonization of regulatory systems to prepare for cross-border transfer of plasma. The meeting brought together representatives from seven World Health Organization (WHO) member states, along with experts from the WHO, the WHO Regional Office for the Western Pacific, and Thailand Institute of Biological Products, for special lectures. Key topics included considerations for cross-border plasma transfers for fractionation, ensuring the safety of blood and blood products in the Western Pacific region, and the current status of local plasma-derived medicinal products (PDMPs) production in Thailand. Participating countries also shared their latest experiences and updates on national lot release and biological standardization activities. All participants emphasized the need for ongoing coordination among Asian NCLs to address the increasing movement of plasma across borders and the growing demand for PDMPs in Asia. The meeting concluded with agreements to strengthen regulatory capacities and enhance cooperation among Asian NCLs, with WHO playing a central role in supporting these efforts.