WHO对药品监管部门质量管理体系的要求及云南省药品监督管理局体系建设思考

WHO Requirements for Quality Management System in Drug Regulatory Departments and Reflections on the System Construction of Yunnan Medical Products Administration

以世界卫生组织(WHO)对我国疫苗国家监管体系(NRA)评估为契机,借鉴国际标准,建立并完善云南省药监局疫苗监管体系。本文梳理了全球基准评估工具(GBT)中关于质量管理体系(QMS)的要求,介绍了云南省药监局在准备疫苗NRA评估过程中QMS建设的情况,分析存在的问题和不足,讨论并提出下一步努力和提升的方向。

Taking the vaccine National Regulatory Authority(NRA)evaluation of World Health Organization(WHO)as an opportunity,Yunnan Medical Products Administration is aimed to develop and improve its vaccine regulatory system by aligning with international standards.This article analyzes the requirements for Quality Management System(QMS)outlined by the WHO’s Global Benchmarking Tool(GBT).It introduces the construction of QMS during the preparation for NRA evaluation by Yunnan Medical Products Administration.This paper identifies deficiencies,discusses potential challenges,and provides recommendations for further improvement.