2024 to Be the Year Europe Establishes Psychedelics Regulations

Taking place in April 2024, the European Medicines Agency (EMA) will be hosting a stakeholder workshop aimed at establishing regulatory guidelines for medical psychedelics (1). The meeting will work on creating regulations for both developmental and therapeutic use of psychedelics. Those invited to the workshop will consist of regulators, industry experts, health care professionals, patients, and academia personnel (1). A group of cross-party Members of the European Parliament (MEPs) previously wrote a letter urging the European Union (EU) to move faster on psychedelics which inspired the April 2024 meeting (1,2). The letter was sent to the European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and asked them to, “…play a more active role in the advancement of psychedelic medicines in Europe,” (1).

Psychedelic Health reported that the letter mentions how the (1), “EMA recognises that mental health conditions and substance use disorders are one of the highest public health challenges in Europe, and that the organization is closely following the developments in the field of psychedelic-assisted therapies.” The letter was signed by MEPs members, 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 (1). From the letters, the EMA answered by ensuring that they will work with the EMCDDA regarding psychedelic substances.

The meeting taking place in April 2024, plans to address the need for therapeutic use and development of psychedelics which will be utilized in mental health. As stated in Psychedelic Health, the workshop will delve into topics such as regulatory processes, requirements, and research methods. Some of their talking points will include (1):

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.

All eyes will be on Europe when the stakeholder meeting takes place between April 16-17, 2024 (1).

References

1. Price, S. Europe to Establish Regulatory Guidance on Psychedelics in 2024 https://psychedelichealth-co-uk.cdn.ampproject.org/c/s/psychedelichealth.co.uk/2024/01/17/europe-establish-regulatory-guidance-psychedelics-2024/amp/ (accessed Jan 17, 2024).
2. https://www.ema.europa.eu/en/documents/other/ema-reply-letter-members-european-parliament-mr-agius-saliba-ms-ries-mr-duda-mr-biedron-ms-cerdas-and-ms-metz-concerning-psychedelic-assisted-therapies_en.pdf (accessed Jan 17, 2024).