Affiliations 

  • 1 Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea
  • 2 World Health Organization, Regional Office for the Western Pacific, Manila, Philippines
  • 3 Vaccines Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea
  • 4 National Institute for Biological Standards and Control, Medicine & Healthcare Products Regulatory Agency, London, United Kingdom
  • 5 BNPcare, Seoul, South Korea
  • 6 National Institute of Biologicals, Noida, India
  • 7 National Quality Control Laboratory of Drug and Food, DKI Jakarta, Indonesia
  • 8 National Institute of Infectious Diseases, Tokyo, Japan
  • 9 National Pharmaceutical Regulatory Agency, Petaling Jaya, Malaysia
  • 10 Food and Drug Administration, Muntinlupa City, Philippines
  • 11 National Institute for Control of Vaccine and Biologicals, Ha Noi, Viet Nam
  • 12 Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea. Electronic address: kshin33@korea.kr
Biologicals, 2023 Nov;84:101712.
PMID: 37797484 DOI: 10.1016/j.biologicals.2023.101712

Abstract

The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, the Philippines, and Vietnam) attended the meeting on-site and online. The theme of this meeting was 'Quality Control Issues and International Trends for Biologicals including Vaccines and Plasma-Derived Medicinal Products.' Three special speeches were presented on sharing the quality control system for biologicals, including NCLs' considerations in preparing the WHO Listed Authorities and sharing MFDS experiences. Furthermore, the participating NCLs shared country-specific issues related to national lot releases during the COVID-19 pandemic and acknowledged the meeting's crucial role in response preparedness for pandemic emergencies and enhancing regulatory capacity through coalitions and information exchange among NCLs. The NIFDS will cooperate closely with other Asian NCLs to enhance biological product quality control, aiming to establish regional standards and standardize test methods through collaboration.

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