Regulatory Pathways and Ethical Oversight of Advanced Therapy Medicinal Products in Europe
DOI:
https://doi.org/10.5281/zenodo.22274784Keywords:
Advanced therapy medicinal products; Marketing authorisation; Hospital exemption; Conditional approval; European Union regulationAbstract
Background: Regulation (EC) No 1394/2007 made advanced therapy medicinal products medicines, routed them through a
compulsory centralised procedure, and created a dedicated committee to assess them.
Objective: To judge the framework on its authorisations, withdrawals and hospital exemption.
Methods: Narrative review of legal instruments, authorisation-timeline analyses and comparative regulatory literature.
Findings: Twenty-seven products held authorisation as of 30 November 2024, with median time to Commission decision of
441 days. Under Article 28, 110 products were approved between 2008 and 2025 and 62 remained available, on data reflecting
January 2025, with national review durations from 14 to 210 days.
Conclusions: The record supports centralised assessment as effective gatekeeping, but not earlier access as the binding
constraint; the exemption lacks a common floor.
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