我国药品加快上市注册程序的注册情况分析

Analysis on Registration Situation through the Acceleration of the Drug Listing Registration Process in China

目的:对2020年新修订的《药品注册管理办法》颁布前后我国纳入药品加快上市注册程序并已批准上市的药品信息进行分析,为完善我国药品加快上市注册程序提供参考。方法:检索国家药品监督管理局药品审评中心发布的2019-2021年度药品审评报告,对通过优先审评和药品加快上市注册程序而上市的相关药品数据资料进行信息整理和汇总分析。结果:通过药品加快上市注册程序的上市药品数量逐年增多,优先审评审批资源向临床优势药品和创新药品倾斜。结论:药品加快上市注册程序可为临床价值显著的药品提高审批效率,在一定程度上激发制药企业研制热情,但药品加快上市注册审批体系仍需进一步完善配套政策,细化实施要求,加快专业指南出台,鼓励以临床价值为导向的药品的研发创制,不断提升药品监管部门的服务和监管能力。

Objective:To analyze before and after the promulgation of the newly revised provisions for drug registration(2020),the information on approved drugs included in the acceleration of the drug listing registration process in China,which will provide references for the acceleration of the drug listing registration process.Methods:Through the 2019,2020 and 2021 drug review reports published on the Drug Evaluation of National Medical Products Administration,the listed drug data that have been put on the market through priority review and accelerated listing registration procedures were sorted out and analyzed.Results:The number of listed drugs undergoing accelerated listing registration procedures has increased year by year,and the priority review and approval resources are tilted towards clinically superior and innovative drugs.Conclusion:The acceleration of the drug listing registration process could improve the approval effi ciency of drugs with signifi cant clinical value,and stimulate the enthusiasm of pharmaceutical enterprises for research and development to a certain extent.However,it is still necessary to further improve the supporting policies,refi ne the implementation requirements,speed up the introduction of professional guidelines,encourage the research and development of drugs guided by clinical value,and continuously improve the service and supervision ability of the drug administration department for the accelerated listing and registration of drugs approval system.