EMA'S new Depression Guideline includes a section on psychedelics
The European Medicines Agency has released a draft guideline on clinical investigation of medicinal products for depression, marking its third revision since 2002. Notably, the draft includes a dedicated chapter on psychedelics, recognizing their unique development needs for treating depression. The guideline also acknowledges the challenges of standardization, training, monitoring, and safety in psychedelic-assisted psychotherapy.
Read the full draft here.