Affiliations 

  • 1 Blood Products Division, Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea
  • 2 Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea
  • 3 Blood and Other Product of Human Origin, Health Products Policy and Standards Department, World Health Organization Headquarters, Geneva, Switzerland
  • 4 Indonesian Food and Drug Authority, Jakarta, Indonesia
  • 5 Vaccines Division, Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea
  • 6 National Institute of Infectious Diseases, Tokyo, Japan
  • 7 National Pharmaceutical Regulatory Agency, Selangor, Malaysia
  • 8 Food and Drug Administration Philippines, Muntinlupa City, Philippines
  • 9 National Institute for Control of Vaccines and Biologicals, Ha Noi, Viet Nam
  • 10 Blood Products Division, Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea. Electronic address: kshin33@korea.kr
Biologicals, 2024 Feb;85:101754.
PMID: 38428357 DOI: 10.1016/j.biologicals.2024.101754

Abstract

The Eighth Asian National Control Laboratory (NCL) Network meeting, entitled "Biological Products Quality Control and Self-Sufficiency Strategy focusing on plasma-derived medicinal products (PDMPs)" was held in Seoul on 31 August 2023. The participants were NCL experts from Indonesia, Japan, Malaysia, the Philippines, Vietnam, and the Republic of Korea. Special lectures included the PDMPs self-sufficiency strategies of the World Health Organization (WHO) and Indonesian Food and Drug Authority, and a case study on Global Benchmarking Tool (GBT) assessment for vaccines by the Korea Ministry of Food and Drug Safety. The NCL delegates shared their current experiences with national lot releases and biological standardisation. The meeting contributed to a mutual understanding of the progress of the PDMPs self-sufficiency among Asian countries, the WHO's support strategies, and the NCL's plan for the preparation of the WHO GBT assessment. In the panel discussion, all participants agreed that building capacity in blood safety in the Asian region and harmonisation of relevant international regulatory requirements will support appropriate emergency preparedness, particularly source materials in the region, and will build the foundation for resolving the PDMPs supply insecurity that has worsened after the COVID-19 pandemic in some countries.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.