Bibliografisk note

Funding Information:
ST reports consulting fees paid directly to his former employee from Cybin, a pharmaceutical company developing psychedelics (no personal payment). DE-WM reports a PhD stipend paid for by an unrestricted grant from COMPASS Pathways, a commercial company involved in trials of psychedelic substances for mental health conditions, that had no involvement in the writing of this Comment. GMK reports grants or contracts from Lundbeck Foundation, Novo Nordisk Foundation, Danish Research Council, the EU and other funding bodies; payment or honoraria from Sage Biogen, Onsero, Pangea, H Lundbeck, and Angelini for consulting, lectures, presentations, or educational events; participation on data safety monitoring board or advisory board for the Human Brain Project, IMIM, Barcelona, and SGK Foundation; is a past President of the ECNP (not paid); and has Novo Nordisk stock options unrelated to the topic discussed (Novo Nordisk has no current therapies under investigation in this field). JL reports grants from the Swedish Research Council, lecture honorarium from Novartis, and financial support and in-kind work to provide investigational products (niacin and psilocybin) for researcher initiated phase 2b trial PSIPET (EudraCT-number: 2020-002790-94) from the non-profit Osmond Foundation. DSS reports grants from the Independent Research Fund Denmark, the Heath Foundation, and the Nordic Research Council; honoraria as speaker for the Lundbeck Foundation; and is a paid scientific adviser for Clerkenwell Health, a commercial company involved in trials of psychedelic substances for mental health conditions. The other authors declare no competing interests. This Comment comes from a collaboration between the EMA, the EMA's Central Nervous System Working Party, and the ECNP. The views expressed in this Comment are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which the authors are employed or affiliated.