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.
Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea.
Biologicals. 2024 Feb;85:101754. doi: 10.1016/j.biologicals.2024.101754. Epub 2024 Mar 1.
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.
第八届亚洲国家控制实验室（NCL）网络会议于 2023 年 8 月 31 日在首尔举行，会议主题为“以关注血浆衍生药品（PDMPs）为重点的生物制品质量控制和自给自足战略”。来自印度尼西亚、日本、马来西亚、菲律宾、越南和韩国的 NCL 专家参加了会议。特别讲座包括世界卫生组织（WHO）和印度尼西亚食品药品监督管理局的 PDMPs 自给自足战略，以及韩国食品药品安全部关于疫苗全球基准测试工具（GBT）评估的案例研究。NCL 代表分享了他们在国家批次放行和生物标准化方面的当前经验。会议有助于亚洲国家 PDMPs 自给自足进展、WHO 支持战略以及 NCL 为 WHO GBT 评估做准备的计划得到相互理解。在小组讨论中，所有与会者一致认为，加强亚洲地区血液安全能力建设和协调相关国际监管要求，将支持适当的应急准备，特别是该地区的源材料，并为解决一些国家在 COVID-19 大流行后 PDMPs 供应不安全问题奠定基础。
