1. European regulation on orphan medicinal products: 10 years of experience and future perspectives
- Author
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Westermark, K, Holm, Bb, Söderholm, M, Llinares Garcia, J, Rivière, F, Aarum, S, Butlen Ducuing, F, Tsigkos, S, Wilk Kachlicka, A, N'Diamoi, C, Borvendég, J, Lyons, D, Sepodes, B, Bloechl Daum, B, Lhoir, A, Todorova, M, Kkolos, I, Kubáčková, K, Bosch Traberg, H, Tillmann, V, Saano, V, Héron, E, Elbers, R, Siouti, M, Eggenhofer, J, Salmon, P, Clementi, Maurizio, Krieviņš, D, Matulevičiene, A, Metz, H, Vincenti, Ac, Voordouw, A, Dembowska Bagińska, B, Nunes, Ac, Saleh, Fm, Foltánová, T, Možina, M, Farnell J, Torrent i., Beerman, B, Mariz, S, Evers, Mp, Greene, L, Thorsteinsson, S, Gramstad, L, Mavris, M, Bignami, F, Lorence, A, Belorgey, C, Committee for Orphan Medicinal Products, and the European Medicines
- Subjects
Pharmacology ,Economic growth ,medicine.medical_specialty ,Traditional medicine ,business.industry ,Alternative medicine ,Legislation ,General Medicine ,Marketing authorization ,Orphan drug ,Drug development ,Drug Discovery ,Drug approval ,Medicine ,media_common.cataloged_instance ,European commission ,European union ,business ,media_common - Abstract
In 2000, regulation on orphan medicinal products was adopted in the European Union with the aim of benefiting patients who suffer from serious, rare conditions for which there is currently no satisfactory treatment. Since then, more than 850 orphan drug designations have been granted by the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products (COMP), and more than 60 orphan drugs have received marketing authorization in Europe. Here, stimulated by the tenth anniversary of the COMP, we reflect on the outcomes and experience gained in the past decade, and contemplate issues for the future, such as catalysing drug development for the large number of rare diseases that still lack effective treatments.
- Published
- 2011
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