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Insights from the European Medicines Agency’s Psychedelics Workshop: A Pα+ Dispatch

On Tuesday the 16th and Wednesday the 17th of April, the European Medicines Agency (EMA) hosted a meeting in Amsterdam, “Multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework”.

Heavy rain and strong winds earlier in the week stunted Schiphol Airport’s capacity, making it a bad trip for some. Still, those attendees that made it to Amsterdam included academics, representatives from drug developers, lawyers, and so on.

Here, we don’t aim to provide a blow-by-blow account of the meeting, but instead share some thematic notes. I also focus more on the Q&A or interactive elements of the workshop, as those are generally where new information or angles are found.

In this Dispatch:

  • Regulatory Remits
  • Disentangling Pharmacotherapy from Psychotherapy
  • Standardisation and Its Discontents
    • Standardising Extra-Pharmacological Elements of Psychedelic Studies
    • Standardising Adverse Event Definition and Reporting
  • Blinding
  • Indication Sequencing: TRD vs. MDD
  • Safety & Post-Trial Support
  • Relationship Between Subjective Effects and Therapeutic Outcomes
  • Deficiencies in Present Data
  • Predicting Treatment Response
  • Rescheduling
  • Incentivising Psychedelic Drug Development in the EU

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Select organisations mentioned in this article: Cybin; Compass Pathways; GH Research; PsyPAN; PsyPal; EFPIA; PAREA; Clerkenwell Health; Lykos Therapeutics; European Medicines Agency (EMA); Food and Drug Administration (FDA).