Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

Since the implementation of the EU Orphan Regulation in 2000, the Committee for Orphan Medicinal Products at the European Medicines Agency has been evaluating the benefits of proposed orphan medicines vs. satisfactory treatment methods. This type of evaluation is foreseen in the Orphan Regulation as...

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Bibliographic Details
Main Authors: Maria E. Sheean, Frauke Naumann-Winter, Giuseppe Capovilla, Maria Elisabeth Kalland, Eva Malikova, Segundo Mariz, Darius Matusevicius, Robert Nistico, Brigitte Schwarzer-Daum, Stelios Tsigkos, Kyriaki Tzogani, Kristina Larsson, Armando Magrelli, Violeta Stoyanova-Beninska
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-08-01
Series:Frontiers in Medicine
Subjects:
orphan designation
satisfactory methods of treatment
significant benefit
orphan regulation
committee for orphan medicinal products
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.744625/full

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https://www.frontiersin.org/articles/10.3389/fmed.2021.744625/full

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