摘要
“药品附条件批准上市”制度是我国新修订的《中华人民共和国药品管理法》《药品注册管理办法》等法规所引入的药品审评制度,旨在完善我国药品注册审评机制,鼓励以临床价值为导向的药物创新,加快具有突出临床价值的临床急需药品上市,缩短新技术临床应用时间。但因我国这一制度建立时间很短,法规制度尚在不断完善,社会理解也各不相同。为充分发挥药品附条件批准上市这一制度在促进新药研发、保障新技术临床获益/风险防控中的积极作用,本研究对中美欧各国和地区的药品附条件批准上市政策进行梳理,重点围绕制度要求、技术内涵以及风险防控等方面展开分析,以期提高社会各界对药品附条件批准上市制度的全面认识,为申请人和药品监管机构在实践中用对、用好附条件批准提供参考。
The"conditional approval of drug listing"system is a drug review system introduced in China newly revised"Drug Administration Law of the People′s Republic of China","Drug Registration Management Measures"and other regulations,with a view to improving my country′s drug registration review mechanism in China,encourage clinical value-oriented drug innovation,accelerate the listing of clinically urgently needed drugs with outstanding clinical value,and shorten the time for clinical application of new technologies.However,due to the short time for the establishment of this system in China,the legal system is still being improved,and social understanding is also different.In order to give full play to the positive role of the"conditional approval of drug listing"system in promoting the research and development of new drugs and ensuring the clinical benefits/risk prevention and control of new technologies.This study sorts out the drug conditional approval process in China,US,and EU,mainly based on regulatory requirements,technical connotations and risk control.It is hoped that all sectors of the society will have a comprehensive understanding of the conditional approval and marketing system of drugs,and to provide references for applicants and drug regulatory agencies to use the conditional approval properly in practice.
作者
唐辉
汤立达
TANG Hui;TANG Lida(Tianjin Institute of Pharmaceutical Research Co., Ltd., Tianjin 300301, China)
出处
《中国医药导刊》
2021年第4期289-295,共7页
Chinese Journal of Medicinal Guide
基金
面向医药产业的产业技术基础公共服务平台建设项目(项目编号:2019-00901-1-1,项目名称:面向医药产业的产业技术基础公共服务平台建设)。
关键词
中美欧
附条件批准
监管要求
药品审评制度
China,US and EU
Conditional approval process
Regulatory requirements
Drug review system
