Innovative medicines: new regulatory procedures for the third millennium

被引：4

作者：

Rasi, Guido ^{[1
,2
]}

Bonini, Sergio ^{[1
,3
,4
]}

机构：

[1] EMA, London, England

[2] Univ Roma Tor Vergata, Rome, Italy

[3] Univ Naples 2, Rome, Italy

[4] Italian Natl Res Council CNR, Rome, Italy

来源：

EXPERT OPINION ON BIOLOGICAL THERAPY | 2015年 / 15卷

基金：

欧盟地平线“2020”;

关键词：

adaptive licensing; clinical trials; European Medicines Agency; health technology assessment; innovative medicines; transparency;

D O I：

10.1517/14712598.2015.1026322

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Despite tremendous progress in science and increasing investment in research and development, patients' access to innovative medicines remains limited. This is in part due to increasing regulatory requirements for product authorisation and cost-constrained national health systems. At the European Medicines Agency (EMA), we have tried to address these constraints by adapting our organisation and activities to changing business models, new technologies, and the current and emerging health needs in Europe. The main EMA initiatives to provide patients with effective, safe and affordable medicines are reviewed.

引用

页码：S5 / S8

页数：4

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