Only days after PAREA called for a European mental health moonshot, the U.S. Advanced Research Projects Agency for Health (ARPA-H) announced a $100 million mental health moonshot aimed at accelerating leading-edge treatments and developing more objective measures in behavioural health. 

Psilocybin Therapy for Psychological Distress in Palliative Care Patients (PsyPal) - the first EU-funded clinical trial of psychedelic therapy - is now underway and actively recruiting participants across its four trial sites in Copenhagen, Groningen, Lisbon and Prague. 

PAREA is pleased to welcome the Women’s Brain Foundation as a new full member. Their membership helps put greater focus on ensuring that sex and gender differences are systematically recognised and addressed across mental health and psychedelic research, policy, and clinical innovation in Europe.

At an event today in Brussels, the Psychedelic Access and Research European Alliance (PAREA) launched its new policy paper, From Lagging to Leading: A Policy Toolkit for Mental Health Innovation “Made in Europe”.

This new initiative aims to strengthen Europe’s competitiveness in biotechnology - a field increasingly recognised as strategic for Europe’s economic sovereignty, innovation leadership, and resilience. The consultation invited stakeholders to identify barriers in the EU’s regulatory and investment environment and propose actions to unlock the next wave of biotech innovation.

PAREA is proud to be a supporting partner of the first-ever Psychedelic Lived Experiences Summit! Too often, the voices of those with lived experience are missing from conversations about psychedelic care. As Pedram Dara says, “research leads to meaningful healing when it’s done with people, not just on them.” The Psychedelic Lived Experiences Summit is changing that by bridging clinical science and lived expertise to explore the real-world impact of psychedelic healing with nuance, humility, and insight.

Today, on World Mental Health Day, we call for mental health to be recognised as a cornerstone of societal well-being and future-readiness, and a defining pillar of Europe’s strategic priorities in the years ahead.

The World Health Organization has released its new guideline on balanced national controlled medicines policies to ensure medical access and safety. PAREA participated in this process as a member of the External Review Group, contributing feedback and recommendations that are reflected in the final text.

Today, the third revision of the European Medicines Agency (EMA) Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Depression officially comes into effect, replacing the 2013 version. 

A new paper by the European Medicines Agency (EMA) and the broader European regulatory network has been published in ACS Pharmacology & Translational Science. Among the co-authors is PAREA’s Project Officer, Francisca Silva. The article, titled “Applying the EU Regulatory Framework to Determine the Benefit−Risk Profile of Psychedelics”, consolidates regulatory insights…

PAREA is proud to partner with Inawe Foundation, organizer of Psymposium Madrid 2025, which will take place at the Illustrious College of Physicians of Madrid from October 2–4, 2025.

Norway has taken an important step in mental health care: its regulator has decided to reimburse the off-label use of generic intravenous ketamine for treatment-resistant depression (TRD).

We are delighted to welcome the Finnish Association for Psychedelic Studies (Psyty) to the PAREA Community Supporters network.

The European Commission has opened a targeted consultation to shape the EU4Health Annual Work Programme 2026 (open 4 August – 30 September 2025). PAREA submitted its contribution, stressing that mental health innovation must become a strategic and structural priority for EU health policy.

On August 11, 2025, PsyPal has reached a major milestone with the inclusion of its first patient in the multi-site clinical trial investigating psilocybin therapy for psychological and existential distress in people with progressive, life-limiting illnesses.

In an unprecedented move for EU healthcare, Germany has become the first EU country—and one of very few in the world—to approve the compassionate use of psychedelic therapy for patients suffering from treatment-resistant depression.

We are happy to officially welcome Irish Doctors for Psychedelic Assisted Therapy (IDPAT) as PAREA’s newest Community Supporter!

PAREA has received a generous €50,000 grant from the Entheon Foundation, recognising our work to integrate psychedelic-assisted mental health treatments into Europe’s healthcare systems.

A new expert commentary is outlining five priorities to advance psychedelic therapies in mental health care. Published on The Mental Elf—an online resource on mental health research—the piece follows the 2024 IMHRF webinar “Making sense of psychedelics: Where is the field and where does it need to go?”

A second major EU-funded project in psychedelic science, following PsyPal, will start in the coming months. INTEGRATE will be a doctoral training network supported by €4.3 million in EU funding through the Marie Skłodowska-Curie Actions.