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Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation.
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.
Afiliación
  • Choi CW; 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.
  • Choi Y; Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea.
  • Maryuningsih YS; Blood and Other Product of Human Origin, Health Products Policy and Standards Department, World Health Organization Headquarters, Geneva, Switzerland.
  • Wibisono B; Indonesian Food and Drug Authority, Jakarta, Indonesia.
  • Kim JW; Vaccines Division, Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea.
  • Ramondrana D; Indonesian Food and Drug Authority, Jakarta, Indonesia.
  • Mizukami T; National Institute of Infectious Diseases, Tokyo, Japan.
  • Ochiai M; National Institute of Infectious Diseases, Tokyo, Japan.
  • Samat AA; National Pharmaceutical Regulatory Agency, Selangor, Malaysia.
  • Mangorangca C; Food and Drug Administration Philippines, Muntinlupa City, Philippines.
  • Thi DL; National Institute for Control of Vaccines and Biologicals, Ha Noi, Viet Nam.
  • Van HP; National Institute for Control of Vaccines and Biologicals, Ha Noi, Viet Nam.
  • Shim SB; 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.
  • Seong SK; 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.
  • Shin IS; 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 ; 85: 101754, 2024 Feb.
Article en En | MEDLINE | ID: mdl-38428357
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pandemias Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Corea del Sur Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pandemias Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Corea del Sur Pais de publicación: Reino Unido