Regulation of advanced therapies in Europe: Are we on the right track?

Sixteen years after regulating advanced therapy medicinal products (ATMPs) in the European Union, few ATMPs have gained marketing authorization. Additionally, market withdrawals for commercial reasons and a lack of reimbursement are de facto blocking patient access. Here, we pinpoint the major facto...

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Bibliographic Details
Published in:Cell stem cell 2023-08, Vol.30 (8), p.1013-1016
Main Authors: Izeta, Ander, Cuende, Natividad
Format: Article
Language:English
Subjects:
Cell- and Tissue-Based Therapy
Europe
European Union
Genetic Therapy
Humans
Marketing
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Summary:Sixteen years after regulating advanced therapy medicinal products (ATMPs) in the European Union, few ATMPs have gained marketing authorization. Additionally, market withdrawals for commercial reasons and a lack of reimbursement are de facto blocking patient access. Here, we pinpoint the major factors underlying this roadblock and how to circumvent it.
ISSN:1934-5909
1875-9777
DOI:10.1016/j.stem.2023.07.004