我国鼓励仿制药品优先审评制度的现状及完善对策  

Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China

作　　者：孙旭丽 马韶青[1] SUN Xuli;MA Shaoqing(School of Humanities,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学人文学院,北京102488

出　　处：《中国药房》2023年第2期129-132,共4页China Pharmacy

基　　金：北京市社会科学基金项目(No.19GLB032);教育部人文社会科学研究一般项目(No.18YJCZH128)。

摘　　要：目的为更好地落实鼓励仿制药品目录内仿制药的优先审评制度提供参考。方法在文献研究的基础上,分析我国2批鼓励仿制药品目录内仿制药实施优先审评的现状,对照该制度在适用中存在的问题,提出相应的解决方案。结果与结论我国共发布2批鼓励仿制药品目录,纳入目录的仿制药有49个品种。我国鼓励仿制药品目录内仿制药的优先审评在立法、首仿药激励、上市后再评价、跨部门协调联动等方面存在一定的不足。建议我国可以从加强立法、完善“首仿药市场独占期”制度、健全仿制药上市后的再评价制度、建立常态化的跨部门协调机制等方面进行完善,从而保障我国仿制药的安全、有效和可及。OBJECTIVE To provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues.METHODS Based on literature research,practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed,and the problems existing in the application of the system were compared to propose corresponding solutions.RESULTS&CONCLUSIONS China has issued two batches of encouraged generic drug catalogues,and there were 49 varieties of generic drugs included in the catalogues.In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues,there were some problems in legislation,incentive system for the first generic drug,post-marketing re-evaluation system,and cross-departmental coordination and linkage mechanism.It is suggested to strengthen legislation,improve the“first generic market exclusivity period”system,perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety,effectiveness and accessibility of generic drugs in China.

关 键 词：仿制药 鼓励仿制药品目录 优先审评制度 完善对策 

分 类 号：R951[医药卫生—药学]