摘要
目的:通过介绍世界卫生组织《WHO关于国家监管机构实施质量管理体系的指南》及相关文件,为我国药监机构的质量管理体系建设提供建议。方法:采用文献检索法,研究《WHO关于国家监管机构实施质量管理体系的指南》《WHO医疗产品国家监管体系评估全球基准工具》《医疗产品良好监管规范》《国家监管机构实施质量管理体系:示例和实践》中关于质量管理体系的相关规定。结果与结论:《WHO关于国家监管机构实施质量管理体系的指南》相关要求与《WHO医疗产品国家监管体系评估全球基准工具》中关于质量管理要求的指标和子指标对应。《医疗产品良好监管规范》提供了通用监管原则。《国家监管机构实施质量管理体系:示例和实践》提供了符合要求的实际参考案例。4份文件结合了医药领域的特殊性,为国家监管机构实施质量管理体系提供系统性指引及具体实践建议,为我国药监机构的改革与发展提供了重要的思路和实践方法,值得借鉴。建议监管机构参考4份文件,开展自评,识别与国际标准的差距,细化绩效指标,制定改进路线图,以质量管理体系建设为抓手提升监管效能。
Objective:To provide recommendations for the quality management system construction of and China's medical product regulatory authorities by introducing"WHO Guideline on the Implementation of Quality Management Systems for National Regulatory Authorities"and related documents.Methods:The literature retrieval method was adopted to study the relevant provisions on the quality management systems in the following documents:"WHO Guideline on the Implementation of Quality Management Systems for National Regulatory Authorities","WHO Global Benchmarking Tool(GBT)for Evaluation of National Regulatory System of Medical Products","Good Regulatory Practices in the Regulation of Medical Products"and"Implementing Quality Management Systems in National Regulatory Authorities:Examples and Practices".Results and Conclusion:The requirements in guideline correspond to the indicators and subindicators of quality management requirements in the"WHO Global Benchmarking Tool(GBT)for Evaluation of National Regulatory System of Medical Products".The"Good Regulatory Practices in the Regulation of Medical Products"provides general regulatory principles.The"Implementing Quality Management Systems in National Regulatory Authorities:Examples and Practices”provides practical reference cases that meet the requirements.These four documents integrate specific characteristics of the pharmaceutical field,provide systematic guidance and practical recommendations for the implementation of quality management systems by national regulatory authorities.These documents provide valuable insights and practical approaches for the reform and development of China's medical product regulatory authorities,serving as a valuable reference.It was recommended that regulatory authorities refer to four documents to conduct self-assessments,identify gaps with international standards,refine performance indicators,and develop improvement roadmaps,using the construction of quality management systems as a leverage to enhance regulatory effectiveness.
作者
庞博
周世杰
李耀华
Pang Bo;Zhou Shijie;Li Yaohua(Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA,Shanghai 201210,China)
出处
《中国药事》
2025年第12期1420-1427,共8页
Chinese Pharmaceutical Affairs
基金
上海市2024年度“科技创新行动计划”软科学研究领域——医疗器械注册审评新工具、新标准、新方法研究(编号24692122800)。
关键词
世界卫生组织
国家监管机构
质量管理体系
WHO关于国家监管机构实施质量管理体系的指南
world health organization
national regulatory authorities
quality management systems
WHO guideline on the implementation of quality management systems for national regulatory authorities
