Regulatory Standards in Orphan Medicinal Product Designation in the EU

Regulatory Standards in Orphan Medicinal Product Designation in the EU

Twenty years of orphan regulation in Europe have now elapsed, with almost 2,400 orphan designated medicinal products and more than 190 orphan products authorised in the EU. Alongside the evolution in understanding of rare diseases, considerable regulatory knowledge has also been accumulated regardin...

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Bibliographic Details
Main Authors: Stelios Tsigkos, Segundo Mariz, Maria Elzbieta Sheean, Kristina Larsson, Armando Magrelli, Violeta Stoyanova-Beninska
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-06-01
Series:Frontiers in Medicine
Subjects:
orphan medicinal product
orphan designation
orphan regulation
significant benefit
COMP
market exclusivity
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.698534/full

Internet

https://www.frontiersin.org/articles/10.3389/fmed.2021.698534/full

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