北京药品监管领域重点实验室建设回顾性分析与对策研究

Retrospective analysis and countermeasure research of the research report on the construction of Beijing Key Laboratory of Drug Regulation

药品监管改革不断推进,短板问题日益凸显.国家药品监督管理局聚焦药品监管和医药产业高质量发展需求,组织药品监管领域重点实验室评审工作.实验室围绕药品监管重点环节,以强化技术支撑体系创新为抓手,将药品检验检测体系建设和监管能力建设相结合.分析本市国家药监局重点实验室运行现状及制约发展因素,借鉴其他领域、地区各级各类重点实验室运行过程中的有利经验,从总体布局、体制机制、评价评估、队伍建设等多个方面提出改善路径,为北京市药品监管领域重点实验室建设提供借鉴,为本市"两品一械"创新发展和监管科学战略需求提供参考.

Drug regulatory reform continues to advance,and the problem of shortcomings is becoming increasingly prominent.The NMPA focuses on the needs of drug supervision and the high-quality development of the pharmaceutical industry and organizes the review of key laboratories in the field of drug supervision.The laboratory focuses on the key links of drug supervision,takes strengthening the innovation of technical support system as the starting point,and combines the construction of drug inspection and testing system with regulatory capacity building.Analyze the operation status and constraints of key laboratories of the State Food and Drug Administration in the city,learn from the favorable experience in the operation of various key laboratories at all levels in other fields and regions,and propose improvement paths from the overall layout,institutional mechanism,evaluation and evaluation,team building and other aspects,so as to provide reference for the construction of key laboratories in the field of drug supervision in Beijing,and provide reference for the innovative development of“two products and one device”in the city and the strategic needs of regulatory science.