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Regulation of advanced therapies in Europe: Are we on the right track?
- Source :
-
Cell stem cell [Cell Stem Cell] 2023 Aug 03; Vol. 30 (8), pp. 1013-1016. - Publication Year :
- 2023
-
Abstract
- 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.<br />Competing Interests: Declaration of interests The authors declare no competing interests.<br /> (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Subjects :
- Humans
Europe
European Union
Genetic Therapy
Marketing
Cell- and Tissue-Based Therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1875-9777
- Volume :
- 30
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Cell stem cell
- Publication Type :
- Academic Journal
- Accession number :
- 37541207
- Full Text :
- https://doi.org/10.1016/j.stem.2023.07.004