Item Type: | Editorial |
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Title: | Defining orphan conditions in the context of the European orphan regulation: challenges and evolution |
Creators Name: | O'Connor, D.J. and Sheean, M.E. and Hofer, M.P. and Tsigkos, S. and Mariz, S. and Fregonese, L. and Larsson, K. and Hivert, V. and Westermark, K. and Naumann-Winter, F. and Stoyanova-Beninska, V. and Barišić, I. and Capovilla, G. and Magrelli, A. and Sepodes, B. |
Abstract: | The definition and acceptability of an orphan condition is pivotal for the assessment of European orphan medicinal product designation applications, and consequently the eligibility for incentives. Here, based on the experiences of the Committee for Orphan Medicinal Products, we discuss how to define orphan conditions in the context of the European regulatory framework. |
Keywords: | Drug Development, Drug Legislation, European Union, Government Regulation, Orphan Drug Production, Rare Diseases |
Source: | Nature Reviews Drug Discovery |
ISSN: | 1474-1776 |
Publisher: | Nature Publishing Group |
Volume: | 18 |
Number: | 7 |
Page Range: | 479-480 |
Date: | July 2019 |
Official Publication: | https://doi.org/10.1038/nrd.2018.128 |
PubMed: | View item in PubMed |
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