世界卫生组织化学药品资格预审分析与探讨  

Analysis and Discussion of World Health Organization Chemical Drug Prequalification

作　　者：徐长波 周萌萌 翟铁伟 Xu Changbo;Zhou Mengmeng;Zhai Tiewei(Center for Food and Drug Inspection of NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100076

出　　处：《中国药事》2025年第4期375-381,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:进一步加强我国化学药品生产企业对世界卫生组织(WHO)检查的理解,促进药品生产质量管理水平提升。方法:对WHO资格预审进行介绍,对WHO资格预审清单和WHO对我国化学药品生产企业检查情况及缺陷进行统计分析。结果及结论:WHO资格预审旨在使世界上每个人都能获得安全、有效和质量可靠的药品,我国化学原料药和制剂通过WHO资格预审的数量均能位列前三。WHO检查以申报的产品为核心,覆盖GMP各要素,2023年WHO对我国药品企业的检查均为常规检查,共提出206项缺陷,平均每次检查提出缺陷约17项,无严重缺陷,高频缺陷主要分布于质量控制和质量保证、确认和验证、文件管理等方面,对照WHO药品检查的情况,建议药品生产企业结合自身产品及实际情况,持续提升生产质量管理水平。Objective:In order to strengthen the understanding of World Health Organization(WHO)inspections in China's drug manufacturing enterprises and promote the improvement of quality managementlevel of drug production.Methods:Introduced the prequalification of the WHO,provided a statistical analysisof the WHO prequalification list and inspections and deficiencies of the WHO on chemical drugs in China.Results and Conclusion:WHO prequalification aims to ensure that everyone in the world has access to safe,effective and reliable medicines.The number of chemical raw materials and preparations in China that havepassed WHO prequalification can rank among the top three.WHO inspection takes the declared products asthe core and covers all GMP elements.In 2023,WHO did not propose serious defects for the inspection ofpharmaceutical enterprises in China,and proposed about 17 defects each time.The high-frequency defectsare mainly distributed in quality control and quality assurance,confirmation and verification,documentmanagement,etc.Against the WHO drug inspection,it is suggested that pharmaceutical manufacturers shouldcontinuously improve the production quality management level in combination with their own products andactual conditions.

关 键 词：世界卫生组织 资格预审 化学药品 检查 缺陷 

分 类 号：R95[医药卫生—药学]