2018年欧美批准新药情况分析

2018年欧美批准新药情况分析

唐菀晨,王迎利

国家药品监督管理局信息中心,国家药品监督管理局信息中心

收稿日期:2019-02-27 修回日期:2019-03-01 出版日期:2019-02-25 发布日期:2019-02-25

Analysis of the New Drugs Approved by FDA and EMA in 2018

Tang Wanchen and

Information Center of National Medical Products Administration,Information Center of National Medical Products Administration

Received:2019-02-27 Revised:2019-03-01 Online:2019-02-25 Published:2019-02-25

摘要/Abstract

摘要： 目的：分析2018年美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）批准新药情况。方法：查询FDA和EMA网站数据信息，用Excel软件进行对比、分析。结果与结论：2018年FDA批准NMEs 59个，其中孤儿药34个，数量均创历史新高；FDA审批效率高，批准的新药质量好、治疗领域多样化，新药申请企业竞争激烈。EMA批准新药84个，批准新药的速度和质量低于FDA，但仍有部分新药早于FDA批准。

Abstract: Objective: To study the new drugs approved by U.S. Food and Drug Administration （FDA）and European Medicines Agency（EMA）in 2018. Methods: Analyzing data collected from FDA and EMA websites with excel software. Results and Conclusion: FDA approved 59 NMEs in 2018， including 34 orphan drugs. These numbers had broken the records. In 2018， FDA ensured the efficiency of review and quality of new drugs. The new drugs had a variety of therapeutic areas and competition for companies. The EMA approved 84 new medicines in 2018.The EMA’s efficiency of review and quality of new drugs were not comparable to that of the FDA， but there were still new drugs approved earlier than FDA.

唐菀晨,王迎利. 2018年欧美批准新药情况分析[J]. .

Tang Wanchen and. Analysis of the New Drugs Approved by FDA and EMA in 2018[J]. .

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