构建满足WHO全球基准评估工具(GBT)的药品监管部门疫苗监管质量管理体系研究  

Research on the Construction of Vaccine Supervision Quality Management of Drug Regulatory Authorities in Compliance with WHO Global Benchmarking Tool(GBT)

作　　者：邢立镛 林秀旎 周慧贤 莫结丽 陈旻[3] Xing Liyong;Lin Xiuni;Zhou Huixian;Mo Jieli;Chen Min(Guangdong Institute for Medical Devices Quality Surveillance and Test,Guangzhou 510663,China;Center for Certification and Evaluation,Guangdong Medical Products Administration,Guangzhou 510080,China;Guangdong Institute for Drug Control,Guangzhou 510663,China;Guangdong Medical Products Administration,Guangzhou 510080,China)

机构地区：[1]广东省医疗器械质量监督检验所,广州510663 [2]广东省药品监督管理局审评认证中心,广州510080 [3]广东省药品检验所,广州510663 [4]广东省药品监督管理局,广州510080

出　　处：《中国药事》2022年第4期391-398,共8页Chinese Pharmaceutical Affairs

基　　金：广东省药品监督管理局科技创新团队项目:广东省疫苗监管质量管理体系示范性应用研究(编号2021TDZ02);广东省药品监督管理局科技创新团队项目:WHO医疗产品国家监管体系评估全球基准工具(GBT)应用研究(编号2021TDZ04)。

摘　　要：目的:以世界卫生组织(World Health Organization,简称WHO)疫苗国家监管体系(National Regulatory Authority,简称NRA)评估为契机,借鉴国际标准,完善我国的疫苗监管体系。方法:对标WHO全球基准评估工具(Global Benchmarking Tool,简称GBT),结合自评估结果以及WHO中期评估反馈的问题,总结现行疫苗监管体系存在的短板,有针对性地改进。结果与结论:当前我国的疫苗监管体系与WHO要求仍存在一定的改善空间,基于现有体系,对标GBT,进一步理顺跨部门的工作衔接、完善操作指引类文件、优化监管资源配置、改进监管绩效考核体系,进而不断健全完善监管体系,提高监管效能,提升公众满意度。Objective:The vaccine NRA(National Regulatory Authority)evaluation of WHO(World Health Organization)was taken as an opportunity to improve the vaccine regulatory system in China by referring to international standards.Methods:By using the WHO-GBT(Global Benchmarking Tool)and analyzing the selfevaluation results and the problem feedback from the WHO mid-term evaluation,the deficiencies of the current vaccine regulatory system were summarized and targeted improvement suggestions were made.Results and Conclusion:Current vaccine regulatory system in our country still leaves certain improvement space compared with the WHO requirements.As far as the existing system is concerned compared to GBT,cross-department cohesion should be further smoothed,the operation guideline files should be improved,the allocation of resources should be optimized and supervision of performance appraisal system should be improved so as to further improve and perfect the regulation system and increase the regulatory efficiency and public satisfaction.

关 键 词：药品监督管理部门 世界卫生组织 全球基准评估工具 质量管理体系 疫苗监管 

分 类 号：R95[医药卫生—药学]