Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin

Research on psychotropics such as cannabinoids and psilocybin is growing worldwide, with drug regulatory agencies recognizing unmet medical needs for mental disorders and cancer-related depression. Preclinical studies and clinical trials show promising results, but current clinical evidence is scarce and regulatory requirements are strict due to high abuse potential. The US FDA has released draft guidance on psychedelic clinical trials, while Europe lags behind the US and Canada in regulating these substances. The article introduces conducting clinical trials with psychotropics and the regulatory requirements for marketing authorization applications as of October 2023, noting that future data will shape European regulation.

Study at a glance

Abstract

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who experience depression. Cannabinoids and psilocybin have shown promising results in preclinical studies and clinical trials, but the current clinical evidence is scarce, and the regulatory requirements are strict due to high potential for drug abuse. The US FDA has recently released a draft, non-binding guidance on clinical trials with psychedelics. Europe is currently falling behind the US and Canada in terms of regulating psychotropic substances. The article provides a general introduction on conducting clinical trials with psychotropics and the regulatory requirements (as of October 2023) when submitting marketing authorisation application. In the near future, as more data becomes available, research on psychotropics will definitely shape the European regulatory landscape.