EMA adopts new guideline for depression trials, with dedicated section on psychedelics

The European Medicines Agency (EMA) has published the third revision of its “Guideline on the clinical investigation of medicinal products for the treatment of depression”, set to take effect in September 2025.

A key update is a dedicated section on psychedelics (Section 4.2.3.4). While the draft version released in 2023 had already signalled this development, the final guideline expands and formalises the European regulatory perspective on how psychedelic compounds should be studied in clinical trials.

PAREA contributed to the public consultation process and welcomes this important step toward greater regulatory clarity in the field of psychedelic drug development.

Read our full News Release: https://tinyurl.com/nr-EMA-dep-gl