疫苗国家监管体系评估监督检查板块GMP要求浅析及对云南省药品检查机构体系建设的思考

A Brief Discussion on Criteria for Vaccine Regulatory Inspection(GMP) of NRA Assessment and Reflections on the Construction of Drug Inspection System of Yunnan Province

目的:通过对世界卫生组织(WHO)疫苗国家监管体系(National Regulatory Authority,NRA)评估标准与过程的分析,对标WHO对监督检查(RI)板块GMP检查的体系要求,提出思考与建议以持续提升本省疫苗监督检查水平,促进本省监管检查体系的进步。方法:基于NRA评估迎检准备经验和评估中WHO专家反馈意见,对WHO全球基准评估工具(GBT工具)进行概述,重点对RI板块指标进行归纳,结合云南省参评准备情况及WHO专家正式评估反馈的问题,总结我省疫苗监管体系存在的短板,提出改进措施。结果与结论:当前我国的疫苗监管体系已达到三级成熟度水平,疫苗监管体系相对健全,尚存在一定改善空间。鉴于目前疫苗GMP检查职责在省级药品监管机构,结合我省工作实际,建议对监督检查质量管理体系开展定期深入的审查,规范检查程序,探索检查员培养模式,进而不断健全完善监管体系,提高监管效能。

Objective:Comparing with World Health Organization(WHO) criteria for National Regulatory Authority(NRA)assessment,to put forward suggestions to continuously improving the level of vaccine supervision and inspection of Yunnan province,and promote the progress of supervision and inspection system of Yunnan province.Methods:Based on the experience of preparing for NRA assessment and feedback from WHO experts in the assessment,by using the WHO-GBT(Global Benchmarking Tool),analyzing the requlatory inspection(RI) indicators and the feedback from the WHO evaluation in Yunnan province,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 has certain improvement space.Combined with the actual work of our province,it is suggested to carry out periodic reviews of the inspection system,standrdize the inspection procedures,explore new models for training inspectors in order to improve the inspection system and the effectiveness of supervision.