EMA announces a multistakeholder workshop on psychedelics

EMA to host a “multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework” in April 2024 in Amsterdam

The European Medicines Agency has announced the “EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework”, scheduled for 16 - 17 April 2024 in Amsterdam, the Netherlands.

This event will bring together patients, healthcare professionals, academia, regulators, and industry to explore the development and use of psychedelic substances as potential treatments for unmet medical needs in mental health.

Key objectives of the workshop include:

-      Gathering insights and perspectives from various stakeholders and experts on the potential benefits of psychedelic treatments.
-      Enhancing understanding of the safe and effective application of psychedelic substances in therapy.
-      Discussing regulatory hurdles in the development and evaluation of psychedelic medicines.
-      Identifying areas requiring additional regulatory guidance.

The event will be live-streamed, with a recording available post-event for those unable to attend live.

This announcement follows the EMA's response in March to a letter from a cross-party group of MEPs, which first proposed the workshop.

PAREA extends its gratitude to the EMA for championing the evidence-based advancement of psychedelic therapies in the EU. Since its inception, PAREA has been in constructive dialogue with the EMA, advocating for such a meeting. In October, PAREA released a policy brief: “Laying the groundwork for psychedelic therapies: insights for the EMA workshop and beyond” aiming to inspire the workshop’s preparations and discussions. The brief advocates for the creation of a multidisciplinary advisory body to guide regulators and professionals in best practices and care standardization.

Browse the EMA announcement and a draft workshop agenda here.