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.

中文翻译：

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2023年第八届亚洲国家控制实验室网络会议报告：血浆源药品自给自足战略和监管协调

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“以血浆源药品（PDMPs）为重点的生物制品质量控制和自给自足战略”。与会者是来自印度尼西亚的NCL专家、日本、马来西亚、菲律宾、越南和韩国。特别讲座包括世界卫生组织（WHO）和印度尼西亚食品药品管理局的PDMP自给自足战略，以及韩国食品药品安全部的疫苗全球基准工具（GBT）评估案例研究。 NCL 代表分享了他们目前在国家批签发和生物标准化方面的经验。此次会议有助于相互了解亚洲国家PDMP自给自足的进展、WHO的支持策略以及NCL准备WHO GBT评估的计划。在小组讨论中，所有与会者一致认为，亚洲地区血液安全能力建设和相关国际监管要求的协调将支持适当的应急准备，特别是该地区的原材料，并将为解决 PDMP 供应不安全问题奠定基础。一些国家的 COVID-19 大流行后情况更加恶化。