Regulation of advanced therapies in Europe: Are we on the right track?
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 37541207.
- Also identified by DOI 10.1016/j.stem.2023.07.004.
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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.
Medical subject headings
- Marketing
- Cell- and Tissue-Based Therapy