Impact of changes in regulatory framework on approval of medicines for rare diseases and applicability to market access policies

Impact of changes in regulatory framework on approval of medicines for rare diseases and applicability to market access policies

The introduction of the Orphan Drug Act in the USA in 1983, followed by adoption of the Orphan Drug Regulation No 141/2000 in the EU in 2000, led to a change in landscape of drug development for rare diseases. The introduction of regulations, guidance documents and incentives aimed at increasing the...

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Bibliographic Details
Main Authors: Fran Brown, Maximilian Vargas, Sanja Stanisic, Geoff Fatzinger, Oxana Iliach
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-04-01
Series:Frontiers in Medicine
Subjects:
rare disease
orphan drug
market access
regulatory policy
approval
marketing
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1474087/full
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