Europe to establish regulatory guidance on psychedelics in 2024
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 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.