Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation

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, Malaysi...

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Veröffentlicht in:Biologicals 2024-02, Vol.85, p.101754-101754, Article 101754
Hauptverfasser: Choi, Chan Woong, Choi, Youngju, Maryuningsih, Yuyun Siti, Wibisono, Bayu, Kim, Jong Won, Ramondrana, Dio, Mizukami, Takuo, Ochiai, Masaki, Samat, Azraini Abdul, Mangorangca, Caren, Thi, Dung Luu, Van, Hung Pham, Shim, Sun Bo, Seong, Su Kyoung, Shin, In Soo
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Sprache:eng
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Zusammenfassung: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. •Asian national control laboratory experts gathered in Korea.•Plasma-derived medicinal products quality is responsibility of multiple groups.•Cooperation is crucial to support self-sufficiency in Asian countries.•The participants agreed to harmonise regulatory requirements.•The participants agreed to collaborate to enhance the vaccine regulatory system.
ISSN:1045-1056
1095-8320
DOI:10.1016/j.biologicals.2024.101754