The therapeutic potential of psychedelics: the European regulatory perspective

Affiliations

• ¹ European Medicines Agency, 1083 HS Amsterdam, Netherlands. Electronic address: florence.butlen@ema.europa.eu.
• ² Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
• ³ Section Neurology, Psychiatry, Ophthalmology, Federal Institute of Drugs and Medical Devices, Bonn, Germany.
• ⁴ Medicines Evaluation Board Utrecht, Netherlands.
• ⁵ Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland; Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych, Warsaw, Poland.
• ⁶ European Medicines Agency, 1083 HS Amsterdam, Netherlands.
• ⁷ Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden; European College of Neuropsychopharmacology (ECNP) Transnosological Working Group on Psychedelics, Utrecht, Netherlands.
• ⁸ Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; European College of Neuropsychopharmacology (ECNP) Transnosological Working Group on Psychedelics, Utrecht, Netherlands; Institute of Psychology, University of Copenhagen, Copenhagen, Denmark.
• ⁹ Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; European College of Neuropsychopharmacology (ECNP) Transnosological Working Group on Psychedelics, Utrecht, Netherlands; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.