BACKGROUND: Recent years show an exponential increased interest ("renaissance") in the use of psychedelics for the treatment of mental disorders and broader. Some of these treatments, such as psilocybin for depression, are in the process of formal regulation by regulatory bodies in the US (FDA) and Europe (EMA), and as such on the brink of real-world implementation. In the slipstream of these developments increasing commercial initiatives are taking shape. The European Psychiatric Association (EPA) acknowledges both the therapeutic potential of psychedelic substances and the challenges for both research and clinical implementation. Steps need to be taken toward a well-balanced policy based upon sound scientific evidence and research, aiming at safe, ethical responsible integration of psychedelic therapy available for all patients who can potentially benefit. METHODS: In this EPA policy paper, we highlight the potential benefits, and also the challenges of psychedelic treatments, which can be relevant for the future real-world implementation of these treatments. RESULTS: In addition to an overview of the current evidence and hypotheses of working mechanisms of psychedelic treatment, this policy paper specifically highlights the importance of the psychosocial components of the treatment as well as the ethical and professional aspects playing a role in real-world implementation. CONCLUSIONS: Four recommendations are formulated for further research and clinical implementation.

3rd School of Medicine Charles University Prague Czech Republic

Clinical Department National Institute of Mental Health Klecany Czech Republic

Collaborative Antwerp Psychiatric Research Institute University of Antwerp Antwerp Belgium

Department of Neuropsychology and Psychopharmacology Faculty of Psychology and Neuroscience Maastricht University Maastricht The Netherlands

Department of Psychiatry University of Campania Luigi Vanvitelli Naples Italy

Global Alliance of Mental Illness Advocacy Networks Europe Brussels Belgium

Institut Gustave Roussy Psycho Oncology Unit Interdisciplinary Department for the Organization of Patient Pathways Cancer Campus Grand Paris France

Multiversum Psychiatric Hospital Boechout Belgium

Office for Neurological and Psychiatric Disorders European Medicines Agency Amsterdam The Netherlands

Pomeranian Medical University in Szczecin Szczecin Poland

Université Paris Saclay UVSQ Inserm CESP Villejuif France

University Psychiatric Hospital Duffel Belgium

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