近年来美国FDA批准上市药品分析

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (5): 275-280.

近年来美国FDA批准上市药品分析

任瑜, 杨悦^*

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2016-02-03 修回日期:2016-02-03 出版日期:2014-05-08 发布日期:2016-03-02
作者简介:任瑜,女,在读硕士,药事法规与药品政策。

Analysis of Drugs Approved by FDA in Recent Years

REN Yu, YANG Yue^*

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2016-02-03 Revised:2016-02-03 Online:2014-05-08 Published:2016-03-02

摘要/Abstract

摘要： 目的分析近年来FDA批准上市的药品,为我国药品的研发和审批提供借鉴。方法通过查阅文献,分析美国上市药品的数量变化、重点治疗领域和审评时限变化。结果与结论近年来FDA批准上市的药品数量呈增加趋势,对孤儿药、儿科药、肿瘤疾病、神经及精神疾病等治疗领域重视度增加,审评时限逐渐缩短。我国可以参考美国FDA批准上市的药品,改进药品审批政策,从而促进创新药和仿制药的发展。

关键词: FDA, 上市药品, 数量, 治疗领域, 审评时限

Abstract: ObjectiveTo analyze drugs approved by FDA in recent years, and provide references for developing and approving drugs in China. MethodsThis article analyzes the number, review timeline and therapeutic area of drugs approved in America by literature. Resultsand ConclusionThe number of drugs approved by FDA has increased recently, the review timeline is shortened, and they have improved their focus on orphan drug, pediatric drug, cancer area, neurological and psychiatric disease and so on. Our country can refer to the drugs FDA has approved, and improve the policies of drugs approving to facilitate the development of new drugs and generic drugs.

Key words: FDA, marketed drugs, number, therapeutic area, review timeline

中图分类号:

R951

任瑜, 杨悦. 近年来美国FDA批准上市药品分析[J]. 中国药物警戒, 2014, 11(5): 275-280.

REN Yu, YANG Yue. Analysis of Drugs Approved by FDA in Recent Years[J]. Chinese Journal of Pharmacovigilance, 2014, 11(5): 275-280.

参考文献

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