The EMA will host an invitation-only multi-stakeholder workshop on psychedelic substances between 16-17 April 2024 in Amsterdam, the Netherlands.

This two-day workshop will gather together healthcare professionals, regulatory and industry representatives, and patients to discuss the therapeutic potential of psychedelic substances to address unmet medical needs. Proceedings from Amsterdam can be followed live by video feed.

The aim of the workshop is to determine the foundations for EU regulatory guidance on the use of these substances as treatments for mental health conditions.

Attendees must complete the registration form for this event by Friday 16 February 2024.

Split into a series of three sessions, the event will consider safe use and efficacy of psychedelics as well as stakeholder and expert perspectives on their therapeutic potential. The Australian regulator, the Therapeutic Goods Administration (TGA), will present on its perspective having legalised prescription in clinics of two psychedelic substances last year.

Speakers will consider existing clinical experience with psychedelics including lessons learned from the Food and Drug Administration’s (FDA) approval of esketamine, a drug derived from ketamine and approved in 2019 for use in treatment-resistant depression.

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Regulators worldwide have been reconsidering the potential uses of psychedelics as mental health treatments, including conditions such as treatment-resistant depression and post-traumatic stress disorder (PTSD).

“There has been a shift in the way psychedelics are perceived, with academics and researchers showing a renewed interest in their therapeutic value,” said Steffen Thirstrup, Chief Medical Officer at the EMA.

“Understanding the opportunities that psychedelics may bring has never been more relevant, given the toll [that] mental health issues are taking on public health,” he added.


Further reading:

EMA: Multi-stakeholder workshop on psychedelics