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Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency.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