MAPS PBC has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy in treating post-traumatic stress disorder (PTSD). This marks the first instance of a psychedelic-assisted therapy being considered for FDA approval, potentially introducing a novel treatment option for adults with PTSD.

Read the full news release here.

We are pleased to announce our newest Community Supporter: HoloMind - Instytut Terapii Psychodelicznej. Recently launched in Poland, the organization is dedicated to educating about the therapeutic use of psychedelics and advocating for psychedelic treatments in PL. Welcome aboard, HoloMind!

In today's POLITICO Europe Morning Health Care, psychedelics are "driving the day", reflecting the latest updates on efforts across several EU countries to facilitate access to psychedelics as medicines.

Psychedelics Today webinar featured PAREA founder. Tadeusz explores psychedelic breakthroughs and their impact on Europe's mental health. Watch the full webinar here.

Led by the Spanish Presidency, the Council of the EU recently adopted conclusions on mental health, stressing its individual, social, and economic importance. These conclusions urge member states to create cross-sectoral action plans, ensuring timely access to mental health care and establishing an interdisciplinary mental health workforce.

Videos from the MAPS Psychedelic Science Denver conference are now publicly available. PAREA founder, Tadeusz talk starting at the 14-minute mark. The session was moderated by Zara Snapp with esteemed co-panelists Veronica Magar DrPH, MPH, MA, Dr. Larissa J. Maier, and Dr. Prash P. Watch the full video here.

Psychedelics are being recognized among the most promising innovations in the field of brain science at the the European Brain Council - a founding member of PAREA - Brain Innovation Days.

More on Psychedelics and Brain Innovation Days here.

Frédéric Destrebecq, PAREA Vice-Chair, recently presented at a Brussels meeting of the COST Association, focusing on "Advancing Mental Health Research in Europe." PAREA was featured alongside esteemed organizations like the Researcher Mental Health Observatory and European Organization for Rare Diseases. Established in 1979, COST bridges science, policymakers, and society in Europe. Read more details here.

Amidst the EU's critical discussions on pharmaceutical legislation, PAREA has launched a policy paper during the MEP Action Group for the Medical Use of Psychedelics meeting "Innovating Mental Health in the EU Pharma Legislation: Regulatory Pathways for Psychedelic Therapies." You can access the meeting recording and the paper here.

The Psychedelic Society is a not-for-profit, UK-based organization, focusing on cultivating the psychedelic community and delivering education about the safe and responsible use of psychedelics.

On behalf of the MEP Action Group for the Medical Use of Psychedelics, we warmly invite you to an event at the European Parliament, focusing on the potential of psychedelic therapies within the evolving EU pharma legislation context. Find out more and register for an in-person/online participation here: https://tinyurl.com/EU-Par

PAREA met with the EMA CMO Steffen Thirstrup to discuss the EMA upcoming mutli-stakeholder workshop on psychedelics therapies addressing unmet medical needs in Europe. The workshop will take place in April 2024.

PAREA facilitated a session on psychedelic therapies that took place during the 13th Congress of the European Pain Federation EFIC, held in Budapest, Hungary. Deirdre Ryan, Vice-Chair of PAREA was instrumental in creating this opportunity. James Close from the Imperial College London spoke at the session about his research on psychedelics in the realm of pain management.

PAREA is excited to announce the release of its manifesto for the EU Parliament elections in 2024, focusing on transforming mental health care through psychedelic therapies. As Europe grapples with a rising mental health crisis, it offers a forward-thinking approach, advocating for the EU to prioritize mental health and explore innovative treatments. The manifesto also proposes the creation of an EU inter-institutional task force to establish guidelines for the safe and equitable use of psychedelic therapies.

Read Our Manifesto

PAREA is an Association Partner for The Neuro Summit along with the Human Brain Project, the Brain Capital Alliance and more. The Summit, in Lisbon from the 11th to the 13th of October, brings global visionaries in brain health, neuro and mental health-centric digital health, medtech, deeptech, data, and artificial intelligence to chart the course for our collective brain well-being and prowess in the contemporary economy.

Find all the summit details here.

The European Parliament Health Subcommittee (SANT) is developing a mental health report, led by MEP Sara Cerdas, who is also involved in the MEP Action Group for the Medical Use of Psychedelics. During a recent SANT meeting, discussions were held on amendments to the report. PAREA, advocating for the inclusion of psychedelic medicines, is pleased to note a recent amendment recommending further exploration of innovative treatment options, specifically the use of psychedelic-assisted therapies for mental health conditions. The report is set to be adopted later this year.

The European Medicines Agency has released a draft guideline on clinical investigation of medicinal products for depression, marking its third revision since 2002. Notably, the draft includes a dedicated chapter on psychedelics, recognizing their unique development needs for treating depression. The guideline also acknowledges the challenges of standardization, training, monitoring, and safety in psychedelic-assisted psychotherapy.

Read the full draft here.

The American Journal of Endocannabinoid Medicine interviewed PAREA Founder, Tadeusz Hawrot, during the MIND Foundation INSIGHT 2023 conference about the work of PAREA and the wider EU landscape.

Read the full interview here.

Our September edition of PAREA EU Insights is out! Stay updated on the latest EU policy news. Highlights including: PAREA’s call to establish a Psychedelics Advisory board, the first time psychedelics are mentioned in official EU documents, and more. Read the full EU Insights here.

Psychedelic Health featured PAREA’s call for a European advisory body on psychedelics in a recent policy briefing to the European Medicines Agency (EMA), aligning with the EMA's 2023 workshop on the topic. This development responds to a letter from cross-party MEPs, including Alex Agius Saliba, Robert Biedroń, and Sara Cerdas, urging swift EU action on psychedelics. Tadeusz Hawrot, Founder and Director of PAREA, emphasizes the need for a multidisciplinary advisory body to establish standards and facilitate regulatory approval for psychedelic therapies.

Read the full article here.