What is the European Medicines Agency?

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Abstract

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.

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Journal

Journal ID (iso-abbrev): Epidemiol Psychiatr Sci

Title: Epidemiology and psychiatric sciences

Publisher: Cambridge University Press (CUP)

ISSN: 2045-7960

ISSN (Print): 2045-7960

Publication date (Electronic): Sep 2012

Volume: 21

Issue: 3

Affiliations

[1 ] Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Verona, Italy.

Article

Publisher Item ID: S2045796012000170

DOI: 10.1017/S2045796012000170

PubMed ID: 22793154

SO-VID: 74962f00-9370-4a7f-a249-cce36b88704d

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