Progress in the European Union: Lessons from Multi-Stakeholder Processes

This session offers an overview of the evolving landscape of psychedelic medicine development and regulation in the European Union. Scientific progress in psychedelic therapies must be matched by regulatory engagement and system-level readiness to ensure these therapies are implemented safely, equitably, and effectively. The session will highlight the importance of multi-stakeholder collaboration in driving this progress. PAREA, as a pioneering coalition model, brings together EU-level professional bodies representing clinicians, researchers, patients, and psychedelic organisations to coordinate efforts across sectors and ensure systems are ready for the responsible integration of psychedelic treatments.The power of partnerships will be further illustrated through the European Medicines Agency (EMA) Multi-Stakeholder Workshop on Psychedelics, held in April 2024, and its subsequent outputs. We will present the resulting EMA perspectives on key issues for the development of psychedelics, including methodological challenges, therapeutic frameworks, and safety.