What is the European Medicines Agency?

被引：5

作者：

Bighelli, I. ^{[1
]}

Barbui, C. ^{[1
]}

机构：

[1] Univ Verona, Sect Psychiat, Dept Publ Hlth & Community Med, I-37134 Verona, Italy

来源：

EPIDEMIOLOGY AND PSYCHIATRIC SCIENCES | 2012年 / 21卷 / 03期

关键词：

randomized controlled trial; bias; methods; drug approval;

D O I：

10.1017/S2045796012000170

中图分类号：

R749 [精神病学];

学科分类号：

100205 ;

摘要：

In Europe, new medicines are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency (EMA). This article briefly presents the main roles and responsibilities of the EMA and the key rules that govern the approval process. The main scientific limitations of this process are highlighted, together with some suggestions for dealing with them.

引用

页码：245 / 247

页数：3

共 12 条

[1]

Barbui C, 2011, BRIT MED J, V342, P1187

[2] Regulatory policies on medicines for psychiatric disorders: is Europe on target? [J].