美国FDA肿瘤卓越中心简介及启示  

A Brief Introduction on Oncology Center of Excellence of U. S. FDA and its Implication

作　　者：杨依晗[1] 钟炜杰 YANG Yihan;ZHONG Weijie(Scientific and Technical Information Institute of Shanghai Municipal Food and Drug Administration, Shanghai 200233,China;Law School of East China University of Science and Technology,Shanghai 200237,China)

机构地区：[1]上海市食品药品监督管理局科技情报研究所,上海200233 [2]华东理工大学法学院,上海200237

出　　处：《中国医药导刊》2018年第11期691-695,共5页Chinese Journal of Medicinal Guide

摘　　要：为加快创新抗肿瘤药物和医疗器械的审批速度,美国食品药品管理局(Food and Drug Administration,FDA)为肿瘤相关产品的审评成立肿瘤卓越中心。本文通过对肿瘤卓越中心的成立背景、机构设置和工作机制等进行简介,从我国新药审评审批制度改革的角度提出启示与建议。To speed up the approval of innovative oncology drugs and medical devices,the Food and Drug Administration(FDA)of U.S.has established the Oncology Center of Excellence(OCE)for the review of oncology products.This paper gives a brief introduction about OCE′s background,structure and working mechanism etc.,and puts forward some suggestions from the perspective of the reform of the new drug review and approval system in China.

关 键 词：美国FDA 新药审评审批制度改革 肿瘤卓越中心 抗肿瘤药物 医疗器械审批 

分 类 号：R95[医药卫生—药学]