The opinions expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the Italian Medicines Agency or the Dutch Medicines Evaluation Board.
Letter to the Editors
Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency
Article first published online: 15 MAR 2013
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 75, Issue 4, pages 1149–1151, April 2013
How to Cite
Tafuri, G., Trotta, F., Leufkens, H. G. M. and Pani, L. (2013), Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency. British Journal of Clinical Pharmacology, 75: 1149–1151. doi: 10.1111/j.1365-2125.2012.04424.x
- Issue published online: 15 MAR 2013
- Article first published online: 15 MAR 2013
- Accepted manuscript online: 15 AUG 2012 04:00AM EST
- Manuscript Accepted: 2 AUG 2012
- Manuscript Received: 28 APR 2012
- 2European Medicines Agency. More transparency needed. Lancet 2010; 375: 1753.
- 5Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
- 6Reflection paper: publication of withdrawals of marketing authorisation applications for human medicinal products. London, 5 October 2006. Doc. Ref. EMEA/239350/2005 Rev.1.
- 7Plan for implementation of the pharmacovigilance legislation by the European Medicines Agency Activities to protect and promote public health 2012 in partnership with European Member States. EMA/64750/2012. 2 February 2012.
- 8European Medicines Agency announces plan to publish committee agendas and minutes. EMA/480386/2012 Press release, 18 July 2012.