Applying the EU Regulatory Framework to Determine the Benefit-Risk Profile of Psychedelics.
ACS Pharmacology & Translational Science August 8, 2025 Kate Browne, Ewa Bałkowiec-iskra, André Elferink et al. 1 citation
Marketing authorization applications for psychedelics must align with the regulatory requirements and evidentiary standards required for the approval of all medicinal products in the European Union. While medicine regulators recognize the therapeutic potential of psychedelics, their characteristics present methodological challenges that complicate the design and interpretation of pivotal trials...