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- Title
Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee.
- Authors
Arlett, Peter; Portier, Geraldine; de Lisa, Roberto; Blake, Kevin; Wathion, Noel; Dogne, Jean-Michel; Spooner, Almath; Raine, June; Rasi, Guido
- Abstract
The article discusses the implementation of European Union (EU) pharmacovigilance legislation in July 2012 which improves public health promotion and protection through proper management of drugs in the market. The legislation is noted to focus on the establishment of Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA). Planning, rapid assessment and regulatory action are suggested ways of making safe and effective drugs available in the market.
- Publication
Nature Reviews Drug Discovery, 2014, Vol 13, Issue 5, p395
- ISSN
1474-1776
- Publication type
Article
- DOI
10.1038/nrd3713-c1