The European Medicines Agency (EMA) is set to hold a multi-stakeholder workshop on medical psychedelics in April 2024 to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe.
In what marks an important next step for psychedelics in Europe, the workshop – Towards an EU regulatory framework – will bring together patients, healthcare professionals, academia, regulators and industry.
The meeting is being held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics.
The MEPs wrote to the European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organisations need to play a more active role in the advancement of psychedelic medicines in Europe.
The letter states the EMA recognises that mental health conditions and substance use disorders are one of the highest public health challenges in Europe, and that the organisation is closely following the developments in the field of psychedelic-assisted therapies.
Signatories of the letter included MEPs Alex Agius Saliba, Robert Biedroń and Sara Cerdas of S&D, Jarosław Duda of the EPP, Tilly Metz of the Greens and European Free Alliance, and Frédérique Ries of Renew Europe.
The EMA previously responded to the MEP’s letters confirming the organisation will cooperate with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) on psychedelic substances.
The workshop will discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health across Europe.
The EMA has stated that the workshop will cover research methodology, regulatory processes and requirements and the relevance of real-world data, and aims to:
- Hear the views of stakeholders and experts on the therapeutic potential of psychedelics;
- Provide further clarity on defining the safe and effective use of psychedelics;
- Inform on regulatory challenges associated with the development and evaluation of psychedelic medicines;
- Define areas for which further regulatory guidance is required.
The meeting will be held from 16 to 17 April.
