Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea.
World Health Organization, Regional Office for the Western Pacific, Manila, Philippines.
Biologicals. 2023 Nov;84:101712. doi: 10.1016/j.biologicals.2023.101712. Epub 2023 Oct 3.
The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, the Philippines, and Vietnam) attended the meeting on-site and online. The theme of this meeting was 'Quality Control Issues and International Trends for Biologicals including Vaccines and Plasma-Derived Medicinal Products.' Three special speeches were presented on sharing the quality control system for biologicals, including NCLs' considerations in preparing the WHO Listed Authorities and sharing MFDS experiences. Furthermore, the participating NCLs shared country-specific issues related to national lot releases during the COVID-19 pandemic and acknowledged the meeting's crucial role in response preparedness for pandemic emergencies and enhancing regulatory capacity through coalitions and information exchange among NCLs. The NIFDS will cooperate closely with other Asian NCLs to enhance biological product quality control, aiming to establish regional standards and standardize test methods through collaboration.
世界卫生组织西太平洋和东南亚区域的两区域国家控制实验室网络自 2018 年以来每年举行会议,以增强国家控制实验室的自愿参与能力。该网络的第七次会议于 2022 年 9 月 6 日在韩国食品医药品安全处(MFDS)的韩国国立食品医药品安全评价院(NIFDS)与全球生物大会联合主办下在首尔举行。来自七个国家(印度、印度尼西亚、日本、韩国、马来西亚、菲律宾和越南)的 60 多名与会者亲临现场或在线参加了会议。本次会议的主题是“包括疫苗和血浆衍生药品在内的生物制品的质量控制问题和国际趋势”。会上有三位专家作了关于分享生物制品质量控制系统的特别演讲,包括国家控制实验室在准备世界卫生组织列出的主管当局方面的考虑因素和分享 MFDS 的经验。此外,与会的国家控制实验室还交流了各自国家在 COVID-19 大流行期间国家放行方面的具体问题,并认识到会议在大流行紧急情况应对准备和通过国家控制实验室联盟及信息交流加强监管能力方面的关键作用。NIFDS 将与其他亚洲国家控制实验室密切合作,以加强生物制品的质量控制,旨在通过合作建立区域标准和标准化测试方法。