EMA depression guideline comes into effect; PAREA input published

Today, the third revision of the European Medicines Agency (EMA) Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Depression officially comes into effect, replacing the 2013 version. 

The update introduces regulatory considerations for innovative treatment approaches, particularly psychedelics, with a dedicated section on this topic (4.2.3.4). The section addresses issues such as unblinding, psychological support models, inter-individual variability, and long-term efficacy and safety. This is a major step forward in acknowledging the evolving landscape of psychiatric treatment and the specific methodological challenges of psychedelic trials.

The EMA has also published the external review comments submitted during the public consultation phase. PAREA actively contributed to this review, submitting over 10 detailed comments on the draft guideline. We are pleased that the majority of our proposals were incorporated into the final guideline, including explicit recognition of the role of set and setting, measures to address unblinding and expectancy concerns, and the importance of flexible trial designs.

See the revised guideline here and the external review comments here. tell