Demonstrating significant benefit of orphan medicines: analysis of 15 years of experience in Europe

Author:

Fregonese Laura,Greene Lesley,Hofer Matthias,Magrelli Armando,Naumann-Winter Frauke,Larsson Kristina,Sheean Maria,Stoyanova-Beninska Violeta,Tsigkos Stelios,Westermark Kerstin,Sepodes Bruno

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference32 articles.

1. European Commission website: DG Health and Food Safety>Public health>Rare diseases>Policy. Available at: http://ec.europa.eu/health/rare_diseases/policy/index_en.htm.

2. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2000_141/reg_2000_141_en.pdf.

3. Post-orphan Medicinal Product Designation Procedures. Guidance for sponsors 24 January 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196994.pdf.

4. E-RARE Website: ERA-Net for Research Programmes on Rare Diseases. Available at: http://www.erare.eu/national-rd-funding. [Accessed 20 April 2017].

5. European Commission website: Research & Innovation>Health>Research>Areas>Rare disease. Available at: https://ec.europa.eu/research/health/index.cfm?pg=area&areaname=rare.

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