Chan Woong Choi , Youngju Choi , Yuyun Siti Maryuningsih , Jin Ho Shin , Piyamaporn Chantarasomchin , Takuo Mizukami , Siaw Wee Ng , Dung Luu Thi , Dio Ramondrana , Geraldine N. Dimapilis , Kyung Hee Sohn , Hang Sik Roh , Hyun Jung Koh , Wonjong Lee , Young Hoon Kim
{"title":"2024年第九届亚洲国家控制实验室网络会议报告,重点是区域协调监管系统,为血浆跨境转移做好准备","authors":"Chan Woong Choi , Youngju Choi , Yuyun Siti Maryuningsih , Jin Ho Shin , Piyamaporn Chantarasomchin , Takuo Mizukami , Siaw Wee Ng , Dung Luu Thi , Dio Ramondrana , Geraldine N. Dimapilis , Kyung Hee Sohn , Hang Sik Roh , Hyun Jung Koh , Wonjong Lee , Young Hoon Kim","doi":"10.1016/j.biologicals.2025.101823","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101823"},"PeriodicalIF":1.5000,"publicationDate":"2025-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Chan Woong Choi , Youngju Choi , Yuyun Siti Maryuningsih , Jin Ho Shin , Piyamaporn Chantarasomchin , Takuo Mizukami , Siaw Wee Ng , Dung Luu Thi , Dio Ramondrana , Geraldine N. 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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. 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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
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.
期刊介绍:
Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.