2016年美国FDA批准的新药分析  

Analysis of Novel Drugs Approved by FDA in 2016

作　　者：李轩 周斌[1] 宗欣[2] 

机构地区：[1]中国医药工业研究总院上海医药工业研究院,上海201203 [2]国家食品药品监督管理总局信息中心,北京100053

出　　处：《中国药事》2017年第11期1270-1275,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:对2016年美国FDA批准的新药进行分析,供医药界和相关管理部门参考。方法:通过FDA官网的药物创新专栏与Drugs@FDA数据库查阅、收集FDA批准新药的信息,进行统计分析。结果与结论:2016年,FDA共批准22个新药,比2015年大幅减少,也低于1997-2016年的年均新药数量(28个/年),其中新药申请15个,生物制品许可申请7个。批准新药中获得优先审查、快速通道、突破性治疗和加速审批资格的分别为15个、8个、7个和6个,批准孤儿药9个。批准新药的治疗领域以抗感染药、抗肿瘤药和神经系统用药为主,剂型以注射剂、片剂为主。Objective： To analyze the novel drugs approved by U.S. Food and Drug Administration（FDA） in 2016 so as to provide references for medicine field and related management departments. Methods： The information of the novel drugs approved by FDA was collected from the column of ＂Drug Innovation＂ and Drugs@FDA databases and was analyzed. Results and Conclusion： FDA approved a total of 22 novel drugs in 2016, including 15 new drug applications and 7 biologics license applications. The number of approval in 2016 was smaller than that of 2015, also smaller than the average number between 1997 and 2016（28 per year）. There were 15, 8, 7, 6 and 9 novel drugs belonging to priority review, fast track, breakthrough therapy designation, accelerated approval and orphan product designation respectively. The main therapeutic fields were anti-infectious drugs, antitumor drugs and drugs for nervous system. The main dosage forms of the novel drugs were injections and tablets.

关 键 词：美国食品药品监督管理局 新药申请 生物制品许可申请 孤儿药 新活性物质 处方药申请者付费法案 

分 类 号：R95[医药卫生—药学]