Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin
Medical Writing December 11, 2023 Ivana Turek 1 citation
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 The US FDA has released draft guidance on psychedelic clinical trials, while Europe lags behind the US and Canada in regulating these substances.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.