三十年来欧洲药品审批的集中程序

IF 58.7 1区医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY

Nature Medicine Pub Date : 2025-07-07 DOI:10.1038/s41591-025-03826-0

Emer Cooke, Bruno Sepodes

{"title":"三十年来欧洲药品审批的集中程序","authors":"Emer Cooke, Bruno Sepodes","doi":"10.1038/s41591-025-03826-0","DOIUrl":null,"url":null,"abstract":"Few things epitomize the European Medicines Agency (EMA) as much as its now 30-year-old centralized procedure for approving human medicines. With one submission and one evaluation, a medicine can be authorized simultaneously in all 27 European Union (EU) member states.As the EMA marks its 30th anniversary in 2025 with a year-long series of events at its offices in Amsterdam, it will be reflecting on the far-reaching achievements of the centralized procedure. But it is also a moment for renewed advocacy for international cooperation.","PeriodicalId":19037,"journal":{"name":"Nature Medicine","volume":"37 1","pages":""},"PeriodicalIF":58.7000,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Thirty years of Europe’s centralized procedure for approving medicines\",\"authors\":\"Emer Cooke, Bruno Sepodes\",\"doi\":\"10.1038/s41591-025-03826-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Few things epitomize the European Medicines Agency (EMA) as much as its now 30-year-old centralized procedure for approving human medicines. With one submission and one evaluation, a medicine can be authorized simultaneously in all 27 European Union (EU) member states.As the EMA marks its 30th anniversary in 2025 with a year-long series of events at its offices in Amsterdam, it will be reflecting on the far-reaching achievements of the centralized procedure. But it is also a moment for renewed advocacy for international cooperation.\",\"PeriodicalId\":19037,\"journal\":{\"name\":\"Nature Medicine\",\"volume\":\"37 1\",\"pages\":\"\"},\"PeriodicalIF\":58.7000,\"publicationDate\":\"2025-07-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nature Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1038/s41591-025-03826-0\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nature Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1038/s41591-025-03826-0","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

欧洲药品管理局（EMA）审批人类药品的集中程序已经有30年历史，很少有什么能比这更能体现EMA的特点了。只需一次提交和一次评估，一种药物就可以同时在所有27个欧盟成员国获得批准。2025年，EMA将在阿姆斯特丹的办公室举行为期一年的一系列活动，以纪念其成立30周年，这将反映出集中程序所取得的深远成就。但这也是重新倡导国际合作的时刻。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Thirty years of Europe’s centralized procedure for approving medicines

Few things epitomize the European Medicines Agency (EMA) as much as its now 30-year-old centralized procedure for approving human medicines. With one submission and one evaluation, a medicine can be authorized simultaneously in all 27 European Union (EU) member states.

As the EMA marks its 30th anniversary in 2025 with a year-long series of events at its offices in Amsterdam, it will be reflecting on the far-reaching achievements of the centralized procedure. But it is also a moment for renewed advocacy for international cooperation.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Nature Medicine 医学-生化与分子生物学

CiteScore

100.90

自引率

0.70%

发文量

525

审稿时长

1 months

期刊介绍： Nature Medicine is a monthly journal publishing original peer-reviewed research in all areas of medicine. The publication focuses on originality, timeliness, interdisciplinary interest, and the impact on improving human health. In addition to research articles, Nature Medicine also publishes commissioned content such as News, Reviews, and Perspectives. This content aims to provide context for the latest advances in translational and clinical research, reaching a wide audience of M.D. and Ph.D. readers. All editorial decisions for the journal are made by a team of full-time professional editors. Nature Medicine consider all types of clinical research, including: -Case-reports and small case series -Clinical trials, whether phase 1, 2, 3 or 4 -Observational studies -Meta-analyses -Biomarker studies -Public and global health studies Nature Medicine is also committed to facilitating communication between translational and clinical researchers. As such, we consider “hybrid” studies with preclinical and translational findings reported alongside data from clinical studies.