2019年美国药品食品管理局新药审批简析  

Analysis on new drugs approved by US FDA in 2019

作　　者：周维军 吴冬梅 高阳[1] 王淼[1] 周瑞琦 ZHOU Weijun;WU Dongmei;GAO Yang;WANG Miao;ZHOU Ruiqi(Weizikeng Policlinic of PLA General Hospital Jingzhong Medical District,Beijing 100101,China)

机构地区：[1]解放军总医院京中医疗区苇子坑门诊部,北京100101

出　　处：《临床医药实践》2021年第7期531-531,560,共2页Proceeding of Clinical Medicine

摘　　要：目的:了解美国新药研究分布领域及研究热点。方法:分析美国药品食品管理局(FDA)2019年审批的48个新药的分布特点及审批制度。结果:孤儿新药21个(44.00%),抗肿瘤新药12个(25.00%),血液病和自身免疫性疾病等新药15个(31.25%)。17个新药实行了快速通道审批,9个新药获得“加速批准”,28个新药被指定优先审核,有29个新药使用了至少一个加速审批通道。结论:新药研究领域广,孤儿药和抗肿瘤药是研究热点。多样化快速审批通道提高了审批效率,缩短了新药的上市时间。Objective:To understand the distribution and research hotspots of new drugs in the United States.Methods:Through analysis of the distribution characteristics of 48 new drugs approved by the U.S.Food and Drug Administration(FDA)in 2019 and theapproval system.Results:Twenty-one new drugs for orphans,accounting for 44.00%,12 new anti-tumor drugs,accounting for 25.00%,15 new drugs for blood diseases and autoimmune diseases accounting for 31.25%.17 new drugs implemented fast track approval,9 new drugs received'accelerated approval',28 new drugs were designated for priority review,and 29 new drugs used at least one accelerated approval channel.Conclusion:The research field of new drugs is wide,and orphan drugs and anti-tumor drugs are research hotspots,diversified and fast approval channels improve the approval efficiency and shorten the time to market for new drugs.

关 键 词：美国药品食品管理局 新药审批 孤儿药 

分 类 号：R97[医药卫生—药品]