关于促进进口创新医疗器械在我国同步上市的政策思考  

Policy Considerations on Promoting Simultaneous Market Approval of Imported Innovative Medical Devices in China

作　　者：丁颖田 傅孟元 韩晟[2] 史录文[1,2] 管晓东[1,2] DING Ying-tian;FU Meng-yuan;HAN Sheng;SHI Lu-wen;GUAN Xiao-dong(Department of Pharmacy Administration and Clinical Pharmacy,Peking University;International Research Center for Medicinal Administration,Peking University)

机构地区：[1]北京大学药学院药事管理与临床药学系 [2]北京大学医药管理国际研究中心

出　　处：《中国食品药品监管》2024年第2期50-65,共16页China Food & Drug Administration Magazine

摘　　要：本文梳理了医疗器械创新产品注册程序实施以来,在我国上市的24个进口创新医疗器械的时间,发现与美国上市的时间差平均为4.4年,这与国家提倡的尽快引入先进产品、鼓励全球同步上市的目标尚存在差距。为研究进口创新医疗器械在我国同步上市的影响因素,本文整理了我国创新医疗器械资质申请、临床试验备案和审批以及注册申请的流程与要求,并与美国突破性医疗器械的上市路径进行对比。结果表明,专利申请、型式检验以及临床试验审批是最易导致上市时间滞后的环节,进而影响我国加入全球多中心临床试验和同步研发。本文提出延长创新医疗器械资质时长、规范医疗器械临床阶段变更路径、统一临床试验审批中对境内外企业的要求、加快国际标准本地转化、完善专利制度、允许创新产品自主灵活定价、鼓励境内企业开展海外合作等几点建议,以期为进口创新医疗器械在我国同步上市政策研究提供思路与借鉴。This paper reviews the time of 24 imported innovative medical devices approved in China since the implementation of the innovative medical devices registration procedure,and finds the average time lag is 4.4 years compared to their market launch in the United States,indicating a gap from the national advocacy of promptly introducing advanced products and encouraging global simultaneous market launches.To investigate the factors affecting the simultaneous market entry of imported innovative medical devices in China,this article outlines the processes and requirements for innovative medical device designation application,clinical trial filing and approval,and market application for innovative medical devices.A comparison is made with the marketing pathway for breakthrough medical devices in the United States.The comparison reveals that patent application,type testing,and clinical trial approval are the key stages that most likely contribute to the time lag in market approval,impeding China's participation in global multicenter clinical trials and collaborative research.Therefore,this article proposes relevant policy considerations and recommendations,including extending the designation validity duration of innovative medical devices,standardizing the pathways for device changes during the clinical stage,unifying the requirements for domestic and foreign applicants in clinical trial approvals,accelerating the local translation of international standards,improving the patent system,allowing innovative products set prices independently,and encouraging domestic enterprises to engage in overseas collaborations in multiple ways.

关 键 词：创新医疗器械 同步上市 临床试验审批 型式检验 突破性医疗器械 

分 类 号：R95[医药卫生—药学]