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. 2023 Aug 3;30(8):1013-1016.
doi: 10.1016/j.stem.2023.07.004.

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

Ander Izeta  1 , Natividad Cuende  2
Affiliations
Free article

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

Ander Izeta et al. Cell Stem Cell. .
Free article

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.

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Conflict of interest statement

Declaration of interests The authors declare no competing interests.

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