摘要
结合近年来药械组合产品技术评价研究监管科学项目的研究情况,介绍围绕着如何优化药械组合产品监管工作而开展相关研究,总结项目的研究进展和研究成果,以期促进相关产业的发展。
Based on the research situation of the regulatory scientific research project of combination products technical evaluation in recent years,this study introduces the relevant research on how to optimize the supervision of combination products,summarizes the research progress and research results of the project,in order to promote the development of related industries.
作者
田佳鑫
王永清
TIAN Jiaxin;WANG Yongqing(Center for Medical Device Evaluation,NMPA,Beijing,100081)
出处
《中国医疗器械杂志》
2022年第4期361-364,共4页
Chinese Journal of Medical Instrumentation
关键词
药械组合产品
监管科学
属性界定
技术审评
联合审评
指导原则
combination product
regulatory science
attribution definition
technical review
joint review
guidance