PsyPal Guidance Paper 2026

PsyPal, the first consortium to receive an EU clinical research grant for the study of psychedelic therapy, has published a comprehensive guidance paper to inform stakeholders across research, clinical practice, regulation, policy, advocacy, and industry. The paper outlines key considerations and actionable steps toward the standardisation and implementation of psychedelics in mental healthcare, addressing a critical gap between scientific progress and policy development.
The paper aims to address a gap between research and policy, as mental health emerges as an important priority for the EU, therapeutic innovation and care systems struggle to adapt to the increasing burden on society. Classical and atypical psychedelics demonstrate promising potential for conditions such as treatment-resistant depression, post-traumatic stress disorder, and existential distress. The regulatory and clinical infrastructure needed to support their integration remains uneven and in earlier stages.

Europe is home to a growing number of coalitions, campaigns, and initiatives aiming to inform the future of psychedelic therapies. The field has seen the organisation of a stakeholder event by the European Medicines Agency (EMA) in April 2024, the legal incorporation of the Psychedelic Access and Research European Alliance (PAREA) in December 2024, and publication of a policy paper on psychedelic use in psychiatry by the European Psychiatric Association (EPA) in January 2025.
The authors argue that while the scientific evidence is maturing, the stakeholder environment lacks the cohesive structures necessary to translate research into equitable, safe, and standardised care. To address these challenges, the paper concludes with ten recommendations to guide the formation and sustenance of cross-sector coalitions, campaigns, initiatives, and advisory groups aiming to inform the potential future implementation and standardisation of psychedelic therapies.

The EPA coordinated the research and preparation of the guidance paper, integrating expertise from consortium partners and insights drawn from a consultation process, including 21 stakeholder interviews. The PsyPal project will continue to gather perspectives from across the psychedelic therapy space in Europe, with the aim of fostering engagement and collaboration and with respect to the project's mission of ensuring that individuals experiencing existential distress receive comprehensive support for their spiritual, emotional, and psychological needs.

Associate professors Filipa Sampaio and Inna Feldman of Uppsala Health Economics are responsible for the health economic evaluation of psilocybin-assisted therapy with PsyPal.