European regulation on orphan medicinal products: 10 years of experience and future perspectives

Author:

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Reference21 articles.

1. European Commission. Communication from the commission to the European parliament, the council, the European economic and social committee and the committee of the regions on rare diseases: Europe's challenges. European Commission [online] , (2008).

2. Stolk, P., Willemen, M. J. C & Leufkens, H. G. M. Rare essentials: drugs for rare diseases as essential medicines. Bull. World Health Organ. 84, 745–751 (2006).

3. Aymé, S. EUGLOREH project: the status of health in the European Union: towards a healthier Europe: full report. 5.15. Rare Diseases. EUGLOREH 2007 [online] , (2007).

4. Heemstra, H. E., de Vrueh, R. L., van Weely, S., Büller, H. A. & Leufkens, H. G. Predictors of orphan drug approval in the European Union. Eur. J. Clin. Pharmacol. 64, 545–552 (2008).

5. Haffner, M., Torrent-Farnell, J. & Maher, P. D. Does orphan drug legislation really answer the needs of patients? Lancet 371, 2041–2044 (2008).

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