2013年美国FDA批准新药简析  

Brief analysis on new drugs approved by FDA in 2013

作　　者：张华吉[1] 郭述金[1] 孙玲[1] 温庆辉[1] 程保[1] 

机构地区：[1]国家食品药品监督管理总局信息中心,北京100053

出　　处：《中国新药杂志》2014年第6期619-622,630,共5页Chinese Journal of New Drugs

摘　　要：2013年美国FDA共批准27种新药,其中批准新药申请25种、新生物制剂申请2种。新药批准数量较2012年39种有所下降,与近10年来的年均批准新药数量26种基本相当;新药上市申请数量为36件,总体保持相对稳定;新药创新程度较高,孤儿药热度依然不减,9种首创一类新药、9种孤儿药获得批准;3种新药通过创新以突破性疗法通道获得批准;新药研发重点领域集中在抗肿瘤药、抗微生物药、血液系统用药,新药剂型以片剂与注射剂为主体。虽然2013年FDA批准新药数量低于2012年,但不论是新药的突破性,还是技术的创新性,都取得了较大的进展。The U.S. Food and Drug Administration （FDA） approved a total of 27 novel new drugs, know as new molecular entities （NMEs） in 2013, including 25 new drug applications （NDAs） and 2 new biological ap- plications （BLAs）. The number of approvals in 2013 was down from 2012 with 39 approvals. However when loo- king at the number of approvals over time, 2013 was consistent with the average over time. For instance, between the years 2004 -2013 the average number of NMEs approvals was 26 per year. The number of NMEs applications in 2013 with 36 applications was overall relatively stable. There are 9 approvals of first-in-class drugs and 9 approv- als of orphan drugs. 3 NMEs had breakthrough-therapy designation. The current focus for drug R＆D is on antineo- plastic drugs, antimicrobial drugs, and hematological system drugs. The main dosage forms of the NMEs are tablets and injections. Although the number of NMEs in 2013 is less than in 2012, but the breakthrough of NMEs and technical innovation have made great progress.

关 键 词：新药研发 新分子实体 新药批准 美国食品药品监督管理局 

分 类 号：R95[医药卫生—药学]