50 Organisations

Public Sector Health & Drug Governance

Federal, state, and national regulatory agencies overseeing drug approval, scheduling, and healthcare policy for psychedelics.

When psychedelic treatments move from trials to practice, these are the institutions that decide the terms. Drug regulators approve or reject; health technology assessment agencies (the bodies that judge whether treatments are worth paying for) shape reimbursement; public health institutes run surveillance; and state or provincial authorities operate the programmes that exist today.

The interesting question for each agency is not what it is but what it has actually said or done about psychedelics. Some have published guidance, funded research, or built entire regulatory programmes; others have so far said nothing. Each profile records the agency’s functions, jurisdiction, and psychedelic engagement, with policy instruments (published documents and decisions) linked where they exist.

Organisations
50
Countries
13
Source-verified
0

Specific Groups

By country

What these agencies do about psychedelics

Function Area

Policy Framework Development37
Health System Implementation31
Licensing / Inspection / Compliance29
Clinical Guidance Publication26
Public Health Surveillance12
HTA Evidence Appraisal8
Treatment Program Oversight7
Drug Scheduling / Controlled Substance Governance3

Psychedelic Engagement

Psychedelic-Adjacent Focus30
Explicit Psychedelic Focus15
No Public Psychedelic Focus4

All Organisations

Canadian Drug Agency (CDA-AMC)

Verified2 sources

Canadian public HTA and reimbursement review body supporting evidence appraisal for access decisions.

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Canada

Canadian Institutes of Health Research (CIHR)

OtherVerified3 sources

Canada�s federal health research funding agency setting national biomedical and health-services research priorities.

2 trials
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Centers for Disease Control and Prevention (CDC)

Verified2 sources

U.S. national public health agency responsible for surveillance, risk communication, and epidemiologic guidance.

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United Kingdom

Chief Scientist Office of the Scottish Government

OtherVerified1 source

The Chief Scientist Office (CSO) of the Scottish Government funds NHS and health research across Scotland, and has supported University of Edinburgh evaluability work on ketamine-assisted therapy and the development of the Scottish Psychedelic Research Group to build Scotland’s capacity for psychedelic-assisted therapy studies.

1 trial
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United States

Congressionally Directed Medical Research Programs

OtherVerified3 sources

U.S. federally directed defense-health research program office administering targeted grants, including mental-health priorities.

1 trial
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Brazil

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OtherVerified1 source

Brazil's National Council for Scientific and Technological Development (CNPq) is the country's primary public funding agency for scientific research, providing grants, scholarships, and R&D support to universities and research institutions nationwide. CNPq ranks among the top global funders of psychedelic science, having supported seminal ayahuasca clinical trials, pharmacological studies, and productivity fellowships for researchers who established Brazil as a world leader in psychedelic psychiatry.

1 trial
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Brazil

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OtherVerified1 source

CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior) is Brazil's federal agency for graduate education improvement, providing scholarships, postdoctoral fellowships, and institutional research grants to universities nationwide. Ranked among the top-six global funders of psychedelic research in a 2023 Scopus analysis, CAPES has financed ayahuasca neuroscience studies, clinical investigations, and postdoctoral programmes that underpin Brazil's internationally recognised psychedelic research ecosystem.

1 trial
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Czechia

Czech Health Research Council

OtherVerified1 source

The Czech Health Research Council (AZV ČR) is an organisational component of the Czech Ministry of Health responsible for funding applied health research, distributing over 1 billion CZK annually across approximately 90 supported projects per year. It provided the primary grant for the PSIKET001 trial — a landmark double-blind comparison of psilocybin versus ketamine for treatment-resistant depression at the National Institute of Mental Health — with a total budget of 12 million CZK.

1 trial
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European Centre for Disease Prevention and Control (ECDC)

Verified2 sources

EU public health agency focused on disease surveillance, risk assessment, and evidence dissemination for member states.

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Netherlands

European Medicines Agency (EMA)

Verified2 sources

The European Medicines Agency is a decentralised agency of the European Union. It coordinates the scientific evaluation, supervision and safety monitoring of medicines for human and veterinary use across the EU. Its headquarters are in Amsterdam, the Netherlands.

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European Union Drugs Agency (EUDA)

Verified2 sources

EU public drugs observatory and surveillance body publishing trend and risk evidence including hallucinogen/psychedelic monitoring.

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Federal Joint Committee (G-BA)

Verified2 sources

Germany’s highest joint self-governing HTA decision body for coverage and evidence appraisal, including esketamine/Spravato dossiers.

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United States

Georgia Department of Veterans Services

Other

The Georgia Department of Veterans Services (GDVS) is a Georgia state agency that assists veterans and their dependents in accessing federal VA benefits, healthcare, educational, and social services. The department supports Georgia veterans' access to emerging mental health treatments including ketamine therapy through VA community care partnerships at the Joseph Maxwell Cleland Atlanta VA Medical Center and affiliated clinics.

1 trial
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Germany

German Federal Ministry of Education and Research

OtherVerified1 source

The German Federal Ministry of Education and Research (BMBF) is the pioneering Western government funder of large-scale psychedelic clinical trials, having provided approximately €5 million to the EPIsoDE study — the first government-funded Phase 2 psilocybin trial for treatment-resistant major depression — conducted at the Central Institute for Mental Health in Mannheim and Charité Berlin. Germany subsequently became the first EU country to establish a psilocybin compassionate access program for treatment-resistant depression.

1 trial
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Health Canada

Verified2 sources

Canadian federal health regulator administering controlled access and oversight pathways relevant to psychedelic therapies.

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Ireland

Health Research Board, Ireland

OtherVerified1 source

The Health Research Board (HRB) is Ireland's primary statutory health research funding agency, which has awarded grants to Trinity College Dublin's Psychedelic Research Group to investigate psychedelics' immune effects in depression and the feasibility of psilocybin for cocaine-use disorder. The HRB also funds the KARMA-DEP(2) ketamine trial for treatment-resistant depression at St Patrick's University Hospital in Dublin, making it a key enabler of Ireland's emerging psychedelic medicine ecosystem.

1 trial
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France

Institut National de la Santé Et de la Recherche Médicale, France

OtherVerified1 source

Institut National de la Santé et de la Recherche Médicale (INSERM) is France's national public health and medical research agency, funding and conducting biomedical research across university-hospital institutes throughout the country. INSERM-affiliated researchers at the Paris Brain Institute (ICM) and Pitié-Salpêtrière Hospital have contributed to preclinical and clinical investigations of ketamine and psilocybin as rapid-acting antidepressants.

1 trial
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Mexico

Instituto Mexicano del Seguro Social

OtherVerified3 sources

Instituto Mexicano del Seguro Social (IMSS) is Mexico's largest social security institute, operating the country's most extensive public hospital and clinic network serving over 70 million workers and their families. An IMSS-affiliated facility has participated in clinical research on ketamine for treating depressive symptoms in elderly patients with visual impairment.

1 trial
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Spain

Instituto de Salud Carlos III

OtherVerified1 source

Instituto de Salud Carlos III (ISCIII) is Spain's national public health research agency, managing the CIBERSAM network (Centro de Investigación Biomédica en Red de Salud Mental) which co-funds biomedical mental health research across Spanish universities and hospitals. Through CIBERSAM, ISCIII has co-funded preclinical and translational research on psilocybin as an antidepressant and supports researchers contributing to the European psychedelic therapy landscape.

1 trial
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Mexico

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

OtherVerified3 sources

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE) is Mexico's federal social security institute for government employees, operating a nationwide network of hospitals and clinics serving millions of public-sector workers and their families. An ISSSTE-affiliated facility has participated in clinical research examining ketamine's effect on depressive symptoms in elderly patients with visual impairment.

1 trial
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Italy

Istituto Superiore di Sanità

OtherVerified1 source

Istituto Superiore di Sanità (ISS) is Italy's National Institute of Health, the country's principal technical and scientific public body for biomedical research, public health surveillance, and regulatory advisory functions. The institute has participated in pharmacological research on designer psychoactive substances including methylone, an MDMA analogue, contributing to Italy's evidence base for novel psychoactive substance regulation.

1 trial
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United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA)

Verified2 sources

The Medicines and Healthcare products Regulatory Agency is a UK government agency that regulates medicines, medical devices and blood components for transfusion. It also supports public health by assessing the safety, quality and efficacy of healthcare products, and by enabling innovation and research. Its contact address is in Canary Wharf, London.

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United States

National Cancer Institute (NCI)

OtherVerified1 source

The National Cancer Institute (NCI) is the principal US federal agency for cancer research and training, one of 27 institutes within the National Institutes of Health, with an annual budget exceeding $7 billion. In the psychedelic field, NCI has supported trials exploring psilocybin-assisted therapy for cancer-related demoralization and chronic pain in survivors, as well as ketamine infusion to prevent depression in patients undergoing treatment for pancreatic and head-and-neck cancers.

3 trials
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United States

National Center for Advancing Translational Sciences (NCATS)

OtherVerified1 source

NIH center that accelerates the translation of biomedical discoveries into health solutions. NCATS' Clinical and Translational Science Awards (CTSA) program funds the infrastructure at academic medical centers that supports emerging research including psychedelic-assisted therapy trials.

5 trials
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United States

National Center for Complementary and Integrative Health (NCCIH)

OtherVerified3 sources

U.S. federal institute focused on complementary/integrative research and evidence programs including psychedelic-adjacent contexts.

6 trials
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United States

National Center for PTSD

OtherVerified1 source

The National Center for PTSD (NC-PTSD) is a US Department of Veterans Affairs centre of excellence for research, education, and training on post-traumatic stress disorder, operating across seven VA medical centre sites with a focus on evidence-based assessment and treatment. The Centre has supported mechanistic ketamine research in military and veteran populations, including an investigation of AMPA receptor blockade on ketamine’s anti-suicidal effects relevant to veteran mental health crises.

1 trial
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United States

National Center for Research Resources (NCRR)

OtherVerified1 source

The National Center for Research Resources (NCRR) was a National Institutes of Health centre that funded biomedical research infrastructure, clinical and translational science programmes, and shared research resources until its dissolution in 2011, when its programmes were reorganised primarily into the new National Center for Advancing Translational Sciences (NCATS). NCRR infrastructure and clinical research awards supported early NIH-funded investigations into glutamate-modulating medications for major depressive disorder that laid the mechanistic groundwork for understanding ketamine’s rapid antidepressant effects.

1 trial
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National Centre for Pharmacoeconomics (NCPE)

Verified2 sources

Ireland’s national HTA and pharmacoeconomics body that conducts rapid review and full HTA for reimbursement decisions, including esketamine references.

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Argentina

National Council of Scientific and Technical Research, Argentina

OtherVerified1 source

The National Council of Scientific and Technical Research (CONICET; Consejo Nacional de Investigaciones Científicas y Técnicas) is Argentina’s principal government agency for promoting science and technology, funding over 11,000 researchers and 10,000 doctoral students across a nationwide network of research institutes and centres. CONICET supported the NATMICRO study, a naturalistic observational investigation of the psychological and cognitive effects of self-administered psilocybin microdosing conducted in Argentina.

1 trial
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United Kingdom

National Institute for Health Research, United Kingdom

OtherVerified3 sources

UK public health research funder and implementation infrastructure supporting NHS-oriented evidence generation.

1 trial
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National Institute for Health and Care Excellence (NICE)

Verified2 sources

UK HTA body issuing evidence and cost-effectiveness recommendations that influence medicine access.

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National Institute of Mental Health (NIMH)

Verified2 sources

U.S. federal institute defining mental-health research agendas and evidence-generation priorities including psychedelic-relevant studies.

34 trials
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United States

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

OtherVerified1 source

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is a US National Institutes of Health institute dedicated to research on alcohol use disorder and its public health impacts, supporting approximately $500 million in research annually. NIAAA has funded studies exploring both ketamine administration for acute alcohol use disorder in the emergency department and psilocybin-assisted therapy to understand the neurobehavioral mechanisms underlying alcohol use disorder treatment.

3 trials
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National Institute on Drug Abuse (NIDA)

Verified2 sources

U.S. federal institute setting addiction-research priorities and portfolios, including psychedelic-related investigations.

16 trials
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United States

National Institutes of Health (NIH)

OtherVerified3 sources

U.S. federal biomedical research agency shaping institute-level priority and research funding architecture.

6 trials
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New Mexico Department of Health

Verified4 sources

New Mexico state health authority responsible for implementation and oversight of the Medical Psilocybin Act program.

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United States

Oregon Health Authority

Verified2 sources

Oregon Health Authority is a state government agency in Oregon. Its Oregon Psilocybin Services section regulates psilocybin services in the state, including licensing and compliance for the legal framework created by Oregon Measure 109.

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Oregon Health Authority Pharmacy & Therapeutics Committee

Verified2 sources

State-level Oregon pharmacy and therapeutics decision body supporting evidence-driven formulary and utilization policy.

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Pharmaceutical Benefits Advisory Committee (PBAC)

Verified3 sources

Australia’s HTA and reimbursement advisory body for PBS listing decisions, including esketamine (Spravato) assessment materials.

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Public Health Agency of Canada (PHAC)

Verified2 sources

Canada�s national public health agency responsible for surveillance, risk assessment, and public-health guidance.

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Scottish Medicines Consortium (SMC)

Verified2 sources

Scotland’s public HTA body issuing medicine acceptance guidance, including esketamine (Spravato) advice.

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Substance Abuse and Mental Health Services Administration (SAMHSA)

Verified3 sources

U.S. national public health agency for behavioral health policy and surveillance, including hallucinogen and ketamine epidemiology in national datasets.

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Texas Health and Human Services Commission (HHSC)

Verified2 sources

Texas state health agency overseeing policy functions and implementation of psychedelic-adjacent public initiatives such as ibogaine programs.

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Therapeutic Goods Administration (TGA)

Verified2 sources

Australian national regulator for scheduling, prescribing pathways, and safety oversight including MDMA/psilocybin psychiatry contexts.

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U.S. Department of Veterans Affairs (VA)

Verified3 sources

U.S. federal veterans health authority with explicit psychedelic-adjacent clinical research and care-implementation activity through VA research and care networks.

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U.S. Food and Drug Administration (FDA)

Verified2 sources

US federal regulator for drug development and safety oversight, including psychedelic clinical-investigation pathways.

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UK Health Security Agency (UKHSA)

Verified2 sources

UK national public health agency responsible for surveillance and population-risk evidence, including substance-harm monitoring referenced in ketamine policy review.

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United States

VA Office of Research and Development

OtherVerified3 sources

U.S. Veterans Affairs research authority overseeing national veteran-focused clinical research programs including psychedelic-adjacent initiatives.

9 trials
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Washington State Health Care Authority

Verified2 sources

Washington state health authority overseeing health programs and hosting the state psilocybin task force process under public-health governance structures.

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Washington State Health Care Authority Health Technology Assessment Program

Verified2 sources

Washington State HTA program conducting evidence review that informs state coverage and utilization policy.

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Frequently asked questions

Which government agencies matter for psychedelic medicine?

Four kinds. National ministries and drug agencies (FDA, EMA, MHRA and peers) control approval and scheduling. Health technology assessment agencies (NICE and its counterparts) judge cost-effectiveness for public payers. Public health institutes fund research and run surveillance. State and provincial authorities operate access programmes such as Oregon’s.

What have these agencies actually decided about psychedelics so far?

Australia’s TGA rescheduled MDMA and psilocybin for restricted clinical use in 2023. The US FDA declined the first MDMA application in 2024 while granting breakthrough designations to several programmes. Oregon and Colorado built state-regulated psilocybin programmes. Most other agencies remain in watching mode, which the engagement status on each profile makes visible.

How does my country’s agency compare?

Each agency profile links to coverage countries, and our country pages aggregate the policy picture per jurisdiction, including legal status and programme details. That is usually the faster route if your question starts from a place rather than an institution.