摘要
再生医学与组织工程医疗产品的研发和申报数量日益增多,越来越多国家/地区的监管机构面临该类产品的监管领域的挑战。文章从审评角度谈对再生医学与组织工程医疗产品的几点思考,希望为相关从业人员提供参考和借鉴。
The number of research and submissions of regenerative medicine and tissue engineering products is increasing. More and more regulatory authorities are facing challenges in regulating these products. This article considers the supervision of these products from the perspective of review, in order to provide help for the related staff.
作者
田佳鑫
TIAN Jia-xin(Center for Medical Device Evaluation,NMPA,Beijing 100081;School of Biological Science and Medical Engineering,BUAA,Beijing 100083)
出处
《中国医疗器械信息》
2019年第23期1-2,29,共3页
China Medical Device Information
关键词
再生医学产品
组合产品
监管
regenerative medicine and tissue engineering products
combination products
regulation
