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Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency.

Authors :
Tafuri, Giovanni
Trotta, Francesco
Leufkens, Hubert G. M.
Pani, Luca
Source :
British Journal of Clinical Pharmacology; Apr2013, Vol. 75 Issue 4, p1149-1151, 3p, 1 Graph
Publication Year :
2013

Abstract

The article discusses the process of evaluating new medicines in Europe conducted by regulatory authorities (RAs). It notes on the need for a greater transparency for medical regulations which has been advocated by public and scientific communities and is significant to understand the reasons on certain procedures for a successful or failed application. It indicates that the European Union (EU) has obliged the European Medicines Agency (EMA) to disclose information of drug applications.

Details

Language :
English
ISSN :
03065251
Volume :
75
Issue :
4
Database :
Complementary Index
Journal :
British Journal of Clinical Pharmacology
Publication Type :
Academic Journal
Accession number :
86146874
Full Text :
https://doi.org/10.1111/j.1365-2125.2012.04424.x