关于医疗器械临床试验管理改革的思考  

Thoughts about clinical trials management reform of medical devices

作　　者：蒋海洪[1] 林峰[2] 

机构地区：[1]上海健康医学院,上海201318 [2]上海市食品药品监督管理局,上海200003

出　　处：《中国新药与临床杂志》2017年第8期454-459,共6页Chinese Journal of New Drugs and Clinical Remedies

基　　金：中国药品监督管理研究会基金项目(CSDR-QXJG-2017-0005)

摘　　要：国家食品药品监督管理总局关于改革临床试验管理的相关政策征求意见稿发布后,引起了行业产业的极大关注。本文在回顾医疗器械临床试验现行管理规定的基础上,认为未来医疗器械临床试验机构将会独立发展,临床试验国际数据互认共享将成为可能,临床试验机构市场竞争格局将逐步形成。相关部门应该及时出台相关配套措施,建立高素质的医疗器械伦理委员会,同时要加强临床试验机构的日常管理以及临床试验专业人才的培养。China Food and Drug Administration is seeking advice on how to reform the management of clinical trials that draw great attention from industry. After reviewing the current regulations of medical devices clinical trials, we think that the clinical trial institution of medical devices will develop independently in the future, and that international clinical trial data sharing and recognition between the different countries will be possible, and that clinical trial institution market will be competitive. The government should enact timely relevant measures and establish high- quality ethics committee of medical devices, and strengthen the daily management of clinical trials institutions and provide professional education for clinical trials.

关 键 词：医疗器械 临床试验 伦理学委员会 全面质量管理 管理改革 

分 类 号：R95[医药卫生—药学]