药品检验工作协同性研究
收稿日期: 2025-01-27
修回日期: 2025-05-28
录用日期: 2025-08-02
网络出版日期: 2025-08-06
Study on the Coordination Mechanism of Drug Quality Control Testing
Received date: 2025-01-27
Revised date: 2025-05-28
Accepted date: 2025-08-02
Online published: 2025-08-06
目的：按照药品监管全国“一盘棋”工作思路，落实药品监管央地协同工作要求，借鉴国际药品检验机构通过统一检验技术要求、开展信息共享实现检验结果互认和任务共担的管理实践，加强我国药品检验工作协同性。方法：总结欧洲官方药品质量控制实验室（OMCL）网络和世界卫生组织生物制品质量控制实验室网络（NNB）的工作机制及其在生物制品批签发、上市后抽验和假劣药认定检验方面的管理实践，结合我国国家与地方药品检验机构协作的特点，提出加强我国央地药品检验机构工作协同性的相关建议。结果和结论：建议通过开展能力评估、加强信息交流共享、制定检验技术指南和统一检验表单文书等措施，提升我国国家级与省级药品检验机构注册检验、监督抽验、进口检验、生物制品批签发、假劣药认定检验工作的协同性和一致性，从而提升监管技术支撑合力。
关键词： 药品检验; 协同性; 欧洲官方药品质量控制实验室网络; 世界卫生组织生物制品质量控制实验室网络
仲宣惟
,
黄宝斌
,
刘文婷
,
李璐璐
,
赵芃帛
,
魏蔚
,
薛晶
.
药品检验工作协同性研究
Objective： In accordance with the "coordinated national planning" work approach for drug supervision， and in line with the requirements for the coordinated work of the central and local drug regulatory agencies， drawing on the international management practices of medicines control laboratories to achieve mutual recognition of test results and sharing of tasks through the unification of technical requirements for testing and information sharing， in order to strengthen coordination of drug quality contral testing in China.Methods： To study the working mechanism of the European network of official medicines control laboratories （OMCL） and the World Health Organization's national control laboratory network for biologicals （NNB）， and their management practices in the batch release of biological products， post-market sampling testing， and the identification and testing of counterfeit and substandard drugs. Combined with the characteristics of the collaboration between national and local drug testing institutions in China， relevant suggestions for strengthening coordination among national and regional drug testing institutions in China are put forward.Results and Conclusion： It is recommended to take measures such as conducting capacity assessment， strengthening information exchange and sharing， and formulating technical guidelines and unifed testing forms to improve the synergy and consistency between national and provincial testing institutions in terms of registration testing， post-market sampling test， import inspection， batch release of biological products， and identification and inspection of counterfeit and substandard medicines， thereby enhancing the joint force of regulatory technical support.
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［3］ 国家药品监督管理局.对十四届全国人大一次会议第1676号建议的答复［EB/OL］.（2023-06-28）［2024-12-30］.https：//www.nmpa.gov.cn/directory/web/nmpa/zwgk/jyta/rdjy/20230628111045131.html.
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［14］ 国家药品监督管理局.关于进一步加强生物制品批签发管理工作有关事项的通告［EB/OL］.（2007-11-15）［2025-05-26］.https：//www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20071115000001790.html.
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