Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency

Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency

IntroductionThe study examines the impact of regulatory tools, including PRIority MEdicines (PRIME) scheme, on the marketing authorization (MA) timeline of advanced therapy medicinal products (ATMPs) approved by the European Medicines Agency (EMA).MethodsA retrospective analysis of EMA-approved ATMP...

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Bibliographic Details
Main Authors: Simonita Alaburde, Justinas Ivaska, Greta Kaspute, Tatjana Ivaskiene
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Medicine
Subjects:
gene therapy
somatic-cell therapy
tissue engineering
advanced therapy
marketing authorization
PRIME scheme
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1623689/full
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