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.

PAREA is delighted to welcome Nico Gusac as our new Communications Officer!

Today, the EU4Health Civil Society Alliance launched Health4Europe—a strategic blueprint for the next EU Health Programme. Its goal is to ensure that health remains a top political and financial priority in the upcoming Multiannual Financial Framework (MFF), and to further strengthen the European Health Union.

On Wednesday, February 26th, 2025, a significant milestone was reached in the evolution of psychedelic science and medicine in the Nordic region. In Reykjavik, Iceland, during the conference Psychedelics as Medicine, representatives from all the Nordic psychedelic associations came together for an unprecedented moment of unity.

Just days after presenting in Denver, the PAREA team travelled to Helsinki to participate in the European Academy of Neurology (EAN) Congress, a major event that also marked PAREA’s three-year anniversary.

Australia’s largest private health insurer, Medibank, has committed AUD $10 million (~EUR 6 million) to support patient access to MDMA-assisted therapy for PTSD, along with a health economics and outcomes study led by the Australian National University.

Earlier in June, PAREA’s Founder Tadeusz Hawrot participated in the REAL Summit London, a dynamic gathering of changemakers, investors, and innovators committed to transforming global mental health. Hosted by the REAL Mental Health Foundation, the event spotlighted urgent challenges in mental health care—most notably, the persistent stigma that continues to prevent millions from seeking help.

PAREA will be present next week at  Psychedelic Science 2025, in Denver, Colorado! 

PAREA has submitted a response to the European Commission’s open call for evidence on the EU Biotech Act: “Shaping the EU Biotech Act to Unlock Mental-Health Innovation”. We welcome this ambition, which has highlighted mental health as a critical priority.