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A roadmap for supporting the development of advanced therapy medicinal products in a European framework - PubMed

3 hours ago
  • #Healthcare Innovation
  • #Advanced Therapy Medicinal Products
  • #European Regulatory Framework
  • ATMPs face barriers to implementation in European health systems due to EU regulations, requiring new regulatory mechanisms and incentives.
  • Experts from the European University Hospitals Alliance propose changes at regulatory and organizational levels to promote ATMP development and ensure equitable and fast patient access.
  • Solutions need support from regional, national, and EU authorities to have real-world impact, with insights drawn from academic and rare disease ATMP development.
  • The EU must strengthen its position in the global ATMP landscape, dominated by the US and China, to foster innovation and competitiveness.