Determinants for successful marketing authorisation of orphan medicinal products in the EU

Author:

Putzeist Michelle,Heemstra Harald E.,Garcia Jordi Llinares,Mantel-Teeuwisse Aukje K.,Gispen-De Wied Christine C.,Hoes Arno W.,Leufkens Hubert G.M.

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference31 articles.

1. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. Official Journal of The European Union

2. Why rare diseases are an important medical and social issue;Schieppati;Lancet,2008

3. Are rare diseases still orphans or happily adopted? The challenges of developing and using orphan medicinal products;Dear;Br. J. Clin. Pharmacol.,2006

4. European Medicines Agency, (2011) Committee for Orphan Medicinal Products (COMP) Monthly report 4–5 May 2011. EMA/COMP/135191/2011

5. European regulation on orphan medicinal products: 10 years of experience and future perspectives;Nat. Rev. Drug Discov.,2011

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