Journal Club #22: Applying the EU Regulatory Framework to Determine the Benefit–Risk Profile of Psychedelics
Ben van Arem, MSc (Financial Administrator)
Tuesday 3 March, 2026 8PM CET (7PM GMT, 2PM ET, 11AM PT)
Online via Zoom
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On March 3rd 2026, OPEN’s financial administrator and beloved community member Ben van Arem will present an article that provides the EMA’s (European Medicines Agency) perspective on the main knowledge gaps that must be filled along the path to approval for the medical use of psychedelics in mental healthcare. The principal author of this Viewpoint is Kate Browne who is actually working at the EMA.
Within the EU, approval for new medicines and treatments is typically granted by the EMA, which has already stated its interest in the medical use of psychedelics in 2023. The EMA also organised a multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework in 2024, subsequently leading to newly updated guidelines on the clinical investigation of medicinal products in the treatment of depression in early 2025. If you’d like to take a look at these new guidelines yourself and the dedicated section on psychedelics, refer to page 14 (Section 4.3.2.4.).
Some argue that focussing on the medical application of psychedelics (or in other words, medicalisation) is overly reductionistic. But even if a strict medical application might not do justice to many aspects of psychedelics, many trials have shown that there are clear reasons to believe, it could provide an urgently needed new option for those suffering from mental health conditions and who currently have none.
This first step could eventually lead to broader societal acceptance and access down the road.
But the road to that approval has been a rather bumpy one so far. Given the nature of psychedelics, it is difficult to generate unbiased data in randomised double-blind trials, while also ensuring a certain degree of comparability to existing treatments. The most well known methodological issues are functional unblinding, expectancy and nocebo effects. And several studies seem to point out, that even in attempts to rule out these issues, psychedelics actually do not show as strong effects on depression in clinical trials as are attributed to them.
As a possible explanation, some argue that the issue might just be as simple as how we have been measuring depression (and mental well-being) so far. And within the community supporting the path of medical approval, some also question how the EMA is and will be interpreting the results.
Is the EMA biased? Or are we? Join us and experience the EMA’s point of view, as there is no better discussion than an informed one. We warmly invite you to read the article in advance, but if time is tight and you don’t get around to it, just bring your curiosity.
See you there!
Some argue that focussing on the medical application of psychedelics (or in other words, medicalisation) is overly reductionistic. But even if a strict medical application might not do justice to many aspects of psychedelics, many trials have shown that there are clear reasons to believe, it could provide an urgently needed new option for those suffering from mental health conditions and who currently have none.
This first step could eventually lead to broader societal acceptance and access down the road.
But the road to that approval has been a rather bumpy one so far. Given the nature of psychedelics, it is difficult to generate unbiased data in randomised double-blind trials, while also ensuring a certain degree of comparability to existing treatments. The most well known methodological issues are functional unblinding, expectancy and nocebo effects. And several studies seem to point out, that even in attempts to rule out these issues, psychedelics actually do not show as strong effects on depression in clinical trials as are attributed to them.
As a possible explanation, some argue that the issue might just be as simple as how we have been measuring depression (and mental well-being) so far. And within the community supporting the path of medical approval, some also question how the EMA is and will be interpreting the results.
Is the EMA biased? Or are we? Join us and experience the EMA’s point of view, as there is no better discussion than an informed one. We warmly invite you to read the article in advance, but if time is tight and you don’t get around to it, just bring your curiosity.
See you there!