KETAMED®
Request a consultation
Tall pines seen from below, their trunks converging towards the sky

Psychedelics worldwide: approvals, access and research, country by country

KETAMED is a medically assisted psychedelic therapy clinic, with assessments in Lisbon and sessions in Sintra. This page brings together, from official sources, where ketamine, esketamine, psilocybin, MDMA, LSD and DMT are an approved medicine, special access, a regulated programme, decriminalised, under study or prohibited.

Where each substance is accessible, and under which regime

Each country takes the colour of its status for the chosen substance. The categories are never mixed: an approved medicine is not a non-medical programme, and decriminalising use is not legalising it.

Choose the substance
World map of each substance’s legal and regulatory status. Psilocybin — Canada: Special or compassionate access; United States: In clinical trials; Norway: Prohibited; Uruguay: Prohibited; France: In clinical trials; Sweden: In clinical trials; Poland: In clinical trials; Germany: Special or compassionate access; Greece: In clinical trials; Switzerland: Special or compassionate access; Netherlands: In clinical trials; Portugal: In clinical trials; Spain: In clinical trials; Ireland: In clinical trials; New Zealand: Special or compassionate access; Australia: Special or compassionate access; Denmark: In clinical trials; United Kingdom: In clinical trials; Czech Republic: Special or compassionate access; Oregon (US): Regulated non-medical programme; Colorado (US): Regulated non-medical programme; Washington, D.C. (US): Prohibited.
  • Approved medicine
  • Special or compassionate access
  • Regulated non-medical programme
  • Decriminalised
  • In clinical trials
  • Prohibited
  • Publicly funded
  • Mentioned in a clinical guideline
  • Documented off-label use
  • No data on this page
Tap a country to see its status, date and source. Swipe to see the rest of the map.

Legend

  • Approved medicineA specific product has a marketing authorisation for a specific indication.
  • Special or compassionate accessMedical use without a marketing authorisation: authorised prescribers, case-by-case licences or compassionate-use programmes.
  • Regulated non-medical programmeSupervised, licensed use outside medicine, or religious use recognised by law or by a court.
  • DecriminalisedThe law no longer prohibits personal possession and use of this substance (for example, under a state law), but sale remains illegal. This is not the same as making drug use an administrative offence.
  • In clinical trialsNo access outside research, but with registered clinical trials that have sites in the country.
  • ProhibitedA controlled substance, with no legal access outside authorised research. In some countries, such as Portugal, possession for personal use is an administrative offence rather than a crime, but the substance remains prohibited.
  • Publicly fundedAn official decision by a public body allows the public health system to use and pay for this treatment in the general population, for this indication.
  • Mentioned in a clinical guidelineA national clinical guideline mentions this substance in depression; the text gives the direction: in favour, restrictive or no recommendation. Only official guidelines are on the map; scientific-society guidelines are in the table.
  • Documented off-label useA regulator or government body of the country documents in writing the use of this substance in depression outside its approved indications.
  • No data on this pageFor esketamine and ketamine, an uncoloured country is not classified on this page.

For ketamine, the map shows its status in depression: public funding and official clinical guidelines; scientific-society guidelines and Quebec are in the table. As an anaesthetic, ketamine is a medicine used worldwide and is not under international control, on the recommendation of the World Health Organization’s Expert Committee on Drug Dependence; no regulator has approved it for depression, and its use in psychiatry is off-label, except for esketamine nasal spray. OMS / WHO ECDD; EMA.

Table: status by country and substance

The same information as the map, as text, with the official source and the date each row was checked.

Country or regionSubstanceStatusWhat it meansSource and check
PortugalSee detail Esketamine Approved medicine Authorised in the European Union for treatment-resistant depression in adults, together with an antidepressant. Public funding for hospital use was approved by INFARMED in 2025, for a narrower indication. Since 18 December 2019. EMA (checked 12 November 2026)
INFARMED (checked 12 November 2026)
Ketamine Approved medicine Authorised by INFARMED as an injectable anaesthetic, on restricted prescription for hospital use only; not listed in the tables of Decree-Law 15/93. Use in depression is off-label and requires a psychiatric assessment. Since 25 September 2012. INFARMED (Infomed) (checked 12 November 2026)
Diário da República (checked 12 November 2026)
INFARMED (checked 12 November 2026)
Psilocybin ProhibitedPossession for personal use: administrative offence, not a crime Possession for personal use is an administrative offence, not a crime (Law 30/2000). The substance remains in Table II-A of Decree-Law 15/93: producing or selling it is a crime. Since 1 July 2001. Diário da República (checked 12 November 2026)
Diário da República (checked 12 November 2026)
Psilocybin In clinical trials One phase 2 trial authorised in Portugal (psychological distress in palliative care), with a site at the Champalimaud Foundation. Since 25 November 2024. CTIS (UE) (checked 12 November 2026)
ClinicalTrials.gov (checked 12 November 2026)
MDMA ProhibitedPossession for personal use: administrative offence, not a crime Possession for personal use is an administrative offence, not a crime (Law 30/2000). The substance remains in Table II-A: producing or selling it is a crime. There are no clinical trials with sites in Portugal. Since 1 July 2001. Diário da República (checked 12 November 2026)
Diário da República (checked 12 November 2026)
LSD ProhibitedPossession for personal use: administrative offence, not a crime Possession for personal use is an administrative offence, not a crime (Law 30/2000). The substance remains in Table II-A: producing or selling it is a crime. There are no clinical trials with sites in Portugal. Since 1 July 2001. Diário da República (checked 12 November 2026)
Diário da República (checked 12 November 2026)
DMT and ayahuasca ProhibitedPossession for personal use: administrative offence, not a crime Possession of DMT for personal use is an administrative offence, not a crime (Law 30/2000). DMT remains in Table II-A: producing or selling it is a crime. There are no clinical trials with sites in Portugal. Since 1 July 2001. Diário da República (checked 12 November 2026)
Diário da República (checked 12 November 2026)
European Union Esketamine Approved medicine Centralised European Commission authorisation: esketamine nasal spray, together with an antidepressant, for adults with treatment-resistant depression. Since 18 December 2019. EMA (checked 12 November 2026)
Canada Psilocybin Special or compassionate access Case-by-case requests through Health Canada’s Special Access Program, for serious conditions where other treatments have failed, are unsuitable or unavailable. Since 1 October 2026, this authorisation is part of the new Controlled Substances Regulations. Since 5 January 2022. Health Canada (checked 12 November 2026)
Health Canada (checked 12 November 2026)
Canada Gazette (checked 12 November 2026)
MDMA Special or compassionate access Case-by-case requests through Health Canada’s Special Access Program, on the same terms as psilocybin. Since 5 January 2022. Health Canada (checked 12 November 2026)
Health Canada (checked 12 November 2026)
Canada Gazette (checked 12 November 2026)
Esketamine Approved medicine Authorised by Health Canada on 20 May 2020 for treatment-resistant major depressive disorder in adults, together with an SSRI or SNRI. Since 2 September 2021 also as short-term treatment, with an oral antidepressant, for the rapid reduction of symptoms in major depressive disorder that, in clinical judgement, requires urgent psychiatric care. In December 2020 the national health technology assessment agency recommended that it not be reimbursed. Since 20 May 2020. Health Canada (checked 12 November 2026)
Health Canada (checked 12 November 2026)
Canada's Drug Agency (antiga CADTH) (checked 12 November 2026)
Health Canada (Drug Product Database) (checked 12 November 2026)
Ketamine Mentioned in a clinical guidelineScientific-society guideline, not official Guideline of the Canadian scientific society CANMAT (2023 update, published 2024): intravenous racemic ketamine is a second-line adjunct in difficult-to-treat depression; by other routes, third-line. It is not an official guideline. Since 6 May 2024. CANMAT (Canadian Journal of Psychiatry) (checked 12 November 2026)
Australia Psilocybin Special or compassionate access Prescription by psychiatrists authorised by the TGA, with ethics committee approval, only for treatment-resistant depression. Since 1 July 2023. TGA (Austrália) (checked 12 November 2026)
MDMA Special or compassionate access Prescription by psychiatrists authorised by the TGA, with ethics committee approval, only for post-traumatic stress disorder. Since 1 July 2023. TGA (Austrália) (checked 12 November 2026)
Esketamine Approved medicine Registered by the TGA on 9 March 2021 for treatment-resistant depression in adults, started together with a newly initiated oral antidepressant. Funded by the public medicines scheme (PBS) for treatment-resistant depression since 1 May 2025. Since 9 March 2021. TGA (checked 12 November 2026)
PBS (Governo da Austrália) (checked 12 November 2026)
Ketamine Mentioned in a clinical guidelineScientific-society guideline, not official Professional practice guideline of the Royal Australian and New Zealand College of Psychiatrists (2025): in clinical practice, ketamine should be used only for treatment-resistant depression; other indications only in a clinical trial, an approved regulated access-with-evidence programme or a formal quality-improvement programme. It is not an official guideline. RANZCP (checked 12 November 2026)
New Zealand Psilocybin Special or compassionate access Individual approval of a doctor by the Ministry of Health (Medsafe) to prescribe psilocybin for a defined clinical purpose, outside research. There is no approved psilocybin medicine. Since 24 July 2025. Medsafe (NZ) (checked 12 November 2026)
Medsafe (NZ) (checked 12 November 2026)
Ketamine Mentioned in a clinical guidelineScientific-society guideline, not official Professional practice guideline of the Royal Australian and New Zealand College of Psychiatrists (2025): in clinical practice, ketamine should be used only for treatment-resistant depression; other indications only in a clinical trial, an approved regulated access-with-evidence programme or a formal quality-improvement programme. It is not an official guideline. RANZCP (checked 12 November 2026)
Czech Republic Psilocybin Special or compassionate access Medical use provided for by law, prescribed by psychiatrists or physicians specialised in psychotherapy, after registered medicines have failed, in three defined indications. In March 2026 the national mental health institute stated that treatment was not yet available. Since 1 January 2026. Sbírka zákonů (CZ) (checked 12 November 2026)
NUDZ (CZ) (checked 12 November 2026)
Germany Psilocybin Special or compassionate access Compassionate-use programme in treatment-resistant depression, listed by the federal medicines authority (BfArM) until 17 June 2027. Since 18 June 2026. BfArM (DE) (checked 12 November 2026)
Ketamine Mentioned in a clinical guideline The national care guideline for unipolar depression (version 3.2) is restrictive: intravenous ketamine, used off-label, shall not be used outside inpatient psychiatric care (strong recommendation against). In inpatient care it is accepted only case by case, in the most severe resistant forms, especially with acute suicidality; the guideline makes no recommendation in favour. Since 29 September 2022. BÄK, KBV e AWMF (programa NVL) (checked 12 November 2026)
Switzerland Psilocybin Special or compassionate access Case-by-case exceptional licences from the Federal Office of Public Health for ‘limited medical use’ (322 licences in 2024). Since 2021. BAG / OFSP (CH) (checked 12 November 2026)
BAG / OFSP (CH) (checked 12 November 2026)
MDMA Special or compassionate access Case-by-case exceptional licences for ‘limited medical use’ (236 licences in 2024). Since 2014. BAG / OFSP (CH) (checked 12 November 2026)
BAG / OFSP (CH) (checked 12 November 2026)
LSD Special or compassionate access Case-by-case exceptional licences for ‘limited medical use’ (128 licences in 2024). Since 2014. BAG / OFSP (CH) (checked 12 November 2026)
BAG / OFSP (CH) (checked 12 November 2026)
Esketamine Approved medicine Authorised by Swissmedic on 25 February 2020 for treatment-resistant depression in adults, with an oral antidepressant. On 27 August 2021 the indication was extended to the acute short-term treatment of severe depressive episodes without psychotic symptoms that constitute a psychiatric emergency. Since 25 February 2020. Swissmedic (checked 12 November 2026)
Swissmedic (checked 12 November 2026)
Netherlands MDMA Prohibited Remains on List I of the Opium Act; in 2025 the government decided not to reschedule it and to fund research. It may only be given within clinical research. Since 17 June 2025. Tweede Kamer (NL) (checked 12 November 2026)
wetten.overheid.nl (checked 12 November 2026)
Psilocybin Prohibited Psilocybin and psilocin are on List I, and mushrooms containing them on List II, of the Opium Act. wetten.overheid.nl (checked 12 November 2026)
LSD Prohibited List I of the Opium Act. wetten.overheid.nl (checked 12 November 2026)
DMT and ayahuasca Prohibited List I of the Opium Act. wetten.overheid.nl (checked 12 November 2026)
United Kingdom Psilocybin Prohibited Schedule 1 of the 2001 Regulations (no medical use). In October 2026 the government told Parliament it will not ask for a scheduling review before a marketing authorisation. legislation.gov.uk (checked 12 November 2026)
UK Parliament (checked 12 November 2026)
LSD Prohibited Schedule 1 of the 2001 Regulations. legislation.gov.uk (checked 12 November 2026)
DMT and ayahuasca Prohibited Schedule 1 of the 2001 Regulations. legislation.gov.uk (checked 12 November 2026)
Esketamine Approved medicine Until the end of the Brexit transition period (31 December 2020), the United Kingdom was covered by the EU authorisation of 18 December 2019. On 1 January 2021 the MHRA converted it into a Great Britain authorisation; in Northern Ireland the EU authorisation applied until 31 December 2024 and, since 2025, the British one covers the whole United Kingdom. Indications: treatment-resistant depression in adults, and acute short-term treatment of major depressive episodes that constitute a psychiatric emergency. In England, NICE does not recommend it for treatment-resistant depression (December 2022); in Scotland, the SMC accepted it for treatment-resistant depression (September 2020) but not for the psychiatric emergency (November 2022). Since 1 January 2021. EMA (checked 12 November 2026)
MHRA (gov.uk) (checked 12 November 2026)
MHRA (gov.uk) (checked 12 November 2026)
NICE (checked 12 November 2026)
Scottish Medicines Consortium (checked 12 November 2026)
Scottish Medicines Consortium (checked 12 November 2026)
Norway Psilocybin Prohibited Prohibited by the narcotics regulation, as are the mushrooms that contain it. Lovdata (NO) (checked 12 November 2026)
MDMA Prohibited Prohibited by the narcotics regulation. Lovdata (NO) (checked 12 November 2026)
LSD Prohibited Prohibited by the narcotics regulation. Lovdata (NO) (checked 12 November 2026)
DMT and ayahuasca Prohibited Prohibited by the narcotics regulation. Lovdata (NO) (checked 12 November 2026)
Esketamine Approved medicineNational authorisation date not confirmed As a European Economic Area member, Norway follows the EU authorisation of December 2019; the Norwegian Medicines Agency's assessment quotes the Norwegian indication: treatment-resistant depression in adults, with an SSRI or SNRI. The public specialist health service decided not to introduce it for treatment-resistant depression (April and October 2021; October 2022) and, in 2024, that it should not be used for the psychiatric emergency. EMA (checked 12 November 2026)
Statens legemiddelverk (Noruega) (checked 12 November 2026)
Nye metoder (Noruega) (checked 12 November 2026)
Nye metoder (Noruega) (checked 12 November 2026)
Ketamine Publicly funded On 25 August 2025 the decision forum of the four regional health authorities decided that ketamine may be used for treatment-resistant depression in the public specialist health service, for now in hospital or a district psychiatric centre, with follow-up through a registry or clinical trial until more is known about long-term effects. The decision assumes the same price level and will be reviewed by the end of 2028. The method assessed was intravenous ketamine. Since 25 August 2025. Beslutningsforum for nye metoder (Noruega) (checked 12 November 2026)
Nye metoder (Noruega) (checked 12 November 2026)
Ketamine Documented off-label use The decision of 25 August 2025 requires patients to be told that ketamine for treatment-resistant depression is given outside the approved indication («utenfor godkjent indikasjon»), why, and what that implies. Beslutningsforum for nye metoder (Noruega) (checked 12 November 2026)
Uruguay Psilocybin ProhibitedPossession for personal use: not punished, as assessed by a judge Possession of an amount for personal use, as assessed by a judge, is not punished. Sale remains illegal. Since 9 July 2020. IMPO (UY) (checked 12 November 2026)
MDMA ProhibitedPossession for personal use: not punished, as assessed by a judge Possession of an amount for personal use, as assessed by a judge, is not punished. Sale remains illegal. Since 9 July 2020. IMPO (UY) (checked 12 November 2026)
LSD ProhibitedPossession for personal use: not punished, as assessed by a judge Possession of an amount for personal use, as assessed by a judge, is not punished. Sale remains illegal. Since 9 July 2020. IMPO (UY) (checked 12 November 2026)
DMT and ayahuasca ProhibitedPossession for personal use: not punished, as assessed by a judge Possession of an amount for personal use, as assessed by a judge, is not punished. Sale remains illegal. Since 9 July 2020. IMPO (UY) (checked 12 November 2026)
Brazil DMT and ayahuasca Regulated non-medical programme Religious use of ayahuasca is recognised by a resolution of the National Council on Drug Policy, which excludes trade, advertising and tourism. Isolated DMT remains controlled. Since 25 January 2010. CONAD / gov.br (checked 12 November 2026)
Esketamine Approved medicine Registered by ANVISA (Resolution RE 4,413 of 29 October 2020, published in the Official Gazette on 3 November 2020) for treatment-resistant major depressive disorder in adults, with oral antidepressants, and for the rapid reduction of depressive symptoms in adults with major depressive disorder and acute suicidal behaviour or ideation. Since 29 October 2020. ANVISA / Diário Oficial da União (checked 12 November 2026)
ANVISA (checked 12 November 2026)
United States (federal) Esketamine Approved medicine Approved by the FDA for treatment-resistant depression in adults (2019), for depressive symptoms with acute suicidal ideation (2020) and, since January 2025, also as monotherapy in treatment-resistant depression. Dispensing restricted to certified settings. Since 5 March 2019. FDA (checked 12 November 2026)
FDA (checked 12 November 2026)
Psilocybin In clinical trials No federal approval. A marketing application for psilocybin in treatment-resistant depression was submitted to the FDA on 9 November 2026; in April 2026 the FDA granted priority vouchers to psilocybin programmes. Compass Pathways (checked 12 November 2026)
FDA (checked 12 November 2026)
DMT and ayahuasca Regulated non-medical programme The Supreme Court recognised one church’s (União do Vegetal) sacramental use of ayahuasca, under the religious freedom statute. It is not a general regime. Since 21 February 2006. Supremo Tribunal dos EUA (LII) (checked 12 November 2026)
Ketamine Mentioned in a clinical guideline Federal clinical practice guideline of the Departments of Veterans Affairs and Defense for major depressive disorder (version 4.0, February 2022): suggests ketamine or esketamine as an augmentation option after no response to several adequate pharmacological trials (weak for) and suggests against both as initial treatment. It applies to veterans' and military health services. Since February 2022. VA / DoD (EUA) (checked 12 November 2026)
Oregon (US) Psilocybin Regulated non-medical programme State-licensed psilocybin services for adults over 21, without a prescription, only at a licensed centre and with a facilitator. Outside the programme, possession is again punishable since September 2024. Since November 2020. Oregon Health Authority (checked 12 November 2026)
Oregon Health Authority (checked 12 November 2026)
Colorado (US) Psilocybin Regulated non-medical programme State ‘natural medicine’ programme: licensed healing centres and facilitators, for adults over 21. Since 1 July 2023. Colorado General Assembly (checked 12 November 2026)
DMT and ayahuasca Decriminalised Possession, use and sharing without payment of natural DMT by adults over 21 do not violate state law. Sale outside licences remains a crime. Since 1 July 2023. Colorado General Assembly (checked 12 November 2026)
Washington, D.C. (US) Psilocybin ProhibitedNon-commercial possession: lowest police priority Police must treat non-commercial possession and cultivation by adults over 18 as a lowest priority. The substances remain prohibited under federal law. Since 16 March 2021. Council of the District of Columbia (checked 12 November 2026)
DMT and ayahuasca ProhibitedNon-commercial possession: lowest police priority Police must treat non-commercial possession and cultivation of DMT-containing plants by adults over 18 as a lowest priority. Since 16 March 2021. Council of the District of Columbia (checked 12 November 2026)
Quebec (Canada) Ketamine Mentioned in a clinical guideline INESSS, a Quebec public body, published clinical tools, including a prescription template, for intravenous ketamine as an acute adjunctive treatment of depression refractory to optimised usual therapies in adults. They were announced on 2 June 2026, following an assessment published in May 2025. Since 2 June 2026. INESSS (Quebeque) (checked 12 November 2026)
Ketamine Documented off-label use INESSS states that these tools are meant to frame the off-label use («usage hors indication») of intravenous ketamine in refractory depression (bulletin of 2 June 2026). Since 2 June 2026. INESSS (Quebeque) (checked 12 November 2026)
Chile Esketamine Approved medicine Registered by Chile's Public Health Institute on 8 November 2021 for treatment-resistant depression in adults, with an oral antidepressant. The current record also lists use as monotherapy. Since 8 November 2021. Instituto de Salud Pública de Chile (checked 12 November 2026)
Instituto de Salud Pública de Chile (checked 12 November 2026)
Argentina Esketamine Approved medicine Authorised by ANMAT (certificate 59,173), which already listed it among its August 2020 authorisations, for treatment-resistant depression in adults and for depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behaviour, always with an oral antidepressant. The original registration date was not found in a primary source. ANMAT (checked 12 November 2026)
ANMAT (checked 12 November 2026)
Malaysia Ketamine Mentioned in a clinical guideline Ministry of Health clinical practice guideline for major depressive disorder (2nd edition, 2019): intravenous ketamine may be considered short-term (up to two weeks) in the acute phase of moderate to severe major depressive disorder. Ministério da Saúde da Malásia (MaHTAS) (checked 12 November 2026)
Singapore Esketamine Approved medicine The Ministry of Health states that the Health Sciences Authority approved it in October 2020. The Ministry's national drug formulary lists treatment-resistant depression in adults, as monotherapy or with an SSRI or SNRI, and acute short-term treatment, with an oral antidepressant, of moderate to severe major depressive episodes that constitute a psychiatric emergency. Ministério da Saúde de Singapura (formulário nacional) (checked 12 November 2026)
Ministério da Saúde de Singapura (checked 12 November 2026)
South Korea Esketamine Approved medicine Approved by the Ministry of Food and Drug Safety on 23 June 2020. The current record lists treatment-resistant major depressive disorder in adults and rapid improvement of depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behaviour, always with an oral antidepressant. Since 23 June 2020. MFDS (Coreia do Sul) (checked 12 November 2026)
Taiwan Esketamine Approved medicine Licence issued by Taiwan's Food and Drug Administration on 13 January 2022 for treatment-resistant depression in adults and, with an oral antidepressant, for depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behaviour. Since 13 January 2022. TFDA (Taiwan) (checked 12 November 2026)
South Africa Esketamine Approved medicine Registered by SAHPRA (no. 53/1.2/0732), first authorised on 6 April 2022, for treatment-resistant depression in adults, with an SSRI or SNRI. Since 6 April 2022. SAHPRA (checked 12 November 2026)
Finland Ketamine Mentioned in a clinical guidelineScientific-society guideline, not official National recommendation of the Finnish Medical Society Duodecim and the Finnish Psychiatric Association (June 2026): in a psychiatric hospital, ketamine infusion may be used for rapid relief, for example with suicide risk in severe non-psychotic depression, up to 12 sessions. It is not a government guideline. Since 25 June 2026. Duodecim e Associação Psiquiátrica Finlandesa (checked 12 November 2026)
Austria Ketamine Mentioned in a clinical guidelineScientific-society guideline, not official Consensus statement of the Austrian society for neuropsychopharmacology and biological psychiatry on treatment-resistant depression (2021): with esketamine approved, off-label intravenous ketamine has moved to the background and is reserved for hospital settings. It is not an official guideline. ÖGPB (Áustria) (checked 12 November 2026)
India Ketamine Mentioned in a clinical guidelineScientific-society guideline, not official Indian Psychiatric Society guideline (2026): ketamine or esketamine, where available, as the last step in difficult-to-treat depression, for treatment-resistant depression or major depressive disorder with suicidal thoughts or behaviour; long-term data are limited. It is not an official guideline. Since 27 January 2026. Indian Psychiatric Society (Indian Journal of Psychiatry) (checked 12 November 2026)

Psilocybin: Where this page shows no other regime, it is a controlled substance under the 1971 United Nations Convention on Psychotropic Substances. MDMA: Where this page shows no other regime, it is a controlled substance under the 1971 United Nations Convention on Psychotropic Substances. LSD: Where this page shows no other regime, it is a controlled substance under the 1971 United Nations Convention on Psychotropic Substances. DMT and ayahuasca: Where this page shows no other regime, DMT is a controlled substance under the 1971 United Nations Convention on Psychotropic Substances. Esketamine: This page does not record the status of esketamine in this country. Ketamine: This page records no public funding or official clinical guideline for ketamine in depression in this country. Ketamine is not under international control; each country regulates it as an anaesthetic medicine.

Timeline of regulatory decisions

Approvals, changes in the law and regulators’ decisions, in order.

  1. Portugal

    Portugal decriminalises possession of all drugs for personal use, which becomes an administrative offence.

    Drug-use lawAll controlled substances

    Source: Diário da República

  2. United States (federal)

    The US Supreme Court protects one church’s sacramental use of ayahuasca.

    Regulated non-medical programmeDMT and ayahuasca

    Source: Supremo Tribunal dos EUA (LII)

  3. Brazil

    Brazil regulates the religious use of ayahuasca.

    Regulated non-medical programmeDMT and ayahuasca

    Source: CONAD / gov.br

  4. Switzerland

    Switzerland begins granting case-by-case licences for limited medical use of LSD and MDMA.

    Special or compassionate accessMDMA

    Source: BAG / OFSP (CH)

  5. United States (federal)

    The FDA approves esketamine nasal spray for treatment-resistant depression.

    Approved medicineEsketamine

    Source: FDA

  6. European Union

    The European Union authorises esketamine nasal spray for treatment-resistant depression.

    Approved medicineEsketamine

    Source: EMA

  7. Switzerland

    Psilocybin joins the Swiss limited medical use scheme.

    Special or compassionate accessPsilocybin

    Source: BAG / OFSP (CH)

  8. Washington, D.C. (US)

    Washington, D.C. makes possession of entheogenic plants and fungi a lowest police priority.

    Police priorityPsilocybin

    Source: Council of the District of Columbia

  9. Canada

    Canada begins accepting special access requests for psilocybin and MDMA.

    Special or compassionate accessPsilocybin

    Source: Health Canada

  10. Colorado (US)

    Colorado’s natural medicine law, with licensed centres, comes into force.

    Regulated non-medical programmePsilocybin

    Source: Colorado General Assembly

  11. Australia

    Australia: authorised psychiatrists may prescribe psilocybin and MDMA, in defined indications.

    Special or compassionate accessPsilocybin

    Source: TGA (Austrália)

  12. Portugal

    Portugal clarifies that exceeding the 10-day quantity is only an indication, not proof, of trafficking.

    Drug-use lawAll controlled substances

    Source: Diário da República

  13. United States (federal)

    The FDA does not approve MDMA for post-traumatic stress disorder and asks for a new trial.

    Not approvedMDMA

    Source: FDA; Lykos Therapeutics

  14. United States (federal)

    United States: esketamine may now be used as monotherapy in treatment-resistant depression.

    Approved medicineEsketamine

    Source: FDA

  15. Portugal

    INFARMED approves public funding of esketamine for hospital use, in a narrower indication.

    Approved medicineEsketamine

    Source: INFARMED

  16. Netherlands

    The Netherlands keeps MDMA on List I and funds research.

    ProhibitedMDMA

    Source: Tweede Kamer (NL)

  17. New Zealand

    New Zealand: Medsafe publishes the rules for approving doctors who prescribe psychedelics.

    Special or compassionate accessPsilocybin

    Source: Medsafe (NZ)

  18. Czech Republic

    The Czech Republic provides for medical use of psilocybin in law.

    Special or compassionate accessPsilocybin

    Source: Sbírka zákonů (CZ)

  19. United States (federal)

    The FDA grants priority review vouchers to two psilocybin programmes (treatment-resistant and major depression).

    Regulatory priorityPsilocybin

    Source: FDA

  20. Germany

    Germany: a compassionate-use programme for psilocybin in treatment-resistant depression is listed by the federal medicines authority.

    Special or compassionate accessPsilocybin

    Source: BfArM (DE)

  21. United States (federal)

    First marketing application for a psilocybin medicine submitted to the FDA, for treatment-resistant depression.

    Marketing applicationPsilocybin

    Source: Compass Pathways

What phase the research has reached

The most advanced phase of each substance in each indication. Open a row to see who runs the trials, the registry number and the source.

Substance
Indication studied
PsilocybinTreatment-resistant depression

  • Compass Pathways (Company) · Filed for approval · Application submitted to the FDA (9 Nov 2026); two phase 3 trials met their primary endpoint, according to the sponsor

    Registry: NCT05624268, NCT05711940, 2023-505268-12-00 · Source: Compass Pathways; ClinicalTrials.gov

  • US Department of Veterans Affairs (Hospital) · Phase 3 · Recruiting

    Registry: NCT07226232 · Source: ClinicalTrials.gov

  • Compass Pathways (Company) · Phase 2 · Completed, with a site in Portugal (Champalimaud Foundation) · with a site in Portugal

    Registry: NCT03775200 · Source: ClinicalTrials.gov

PsilocybinMajor depressive disorder

  • Usona Institute (Non-profit) · Phase 3 · Enrolment completed; no results published

    Registry: NCT06308653 · Source: ClinicalTrials.gov

  • Cybin (Helus Pharma) (Company) · Phase 3 · Deuterated analogue (CYB003): one trial completed with no results released, another recruiting

    Registry: NCT06564818, NCT06793397 · Source: ClinicalTrials.gov; ClinicalTrials.gov

PsilocybinPost-traumatic stress disorder

  • Compass Pathways (Company) · Phase 3 · Phase 2/3, recruiting since September 2026

    Registry: NCT07570654 · Source: ClinicalTrials.gov

PsilocybinAlcohol use disorder

  • CHU de Nîmes (Hospital) · Phase 3 · Recruiting

    Registry: NCT07638553, 2025-525069-65-00 · Source: ClinicalTrials.gov

PsilocybinDistress in serious illness

  • NYU Langone (University) · Phase 3 · Phase 2/3, recruiting (advanced cancer)

    Registry: NCT05398484 · Source: ClinicalTrials.gov

  • University Medical Center Groningen (Hospital) · Phase 2 · Recruiting, with a site in Portugal (Champalimaud Foundation) · with a site in Portugal

    Registry: NCT06782724, 2023-510488-36-01 · Source: CTIS (UE); ClinicalTrials.gov

PsilocybinAnorexia nervosa

  • Compass Pathways (Company) · Phase 2 · Proof-of-concept completed

    Registry: NCT05481736 · Source: ClinicalTrials.gov

MDMAPost-traumatic stress disorderNot approved by the FDA (August 2024)

  • Resilient Pharmaceuticals (ex-Lykos) (Company) · Filed for approval · Three phase 3 trials completed. In June 2024 the FDA advisory committee voted 9–2 that the data did not show effectiveness and 10–1 that benefits did not outweigh risks; in August 2024 the FDA did not approve the application (complete response letter) and asked for a new trial on durability of effect, bias and safety. In 2026 the sponsor registered a phase 1 study in healthy volunteers.

    Registry: NCT03537014, NCT04077437, NCT04714359, NCT07584720 · Source: FDA; FDA; Lykos Therapeutics; ClinicalTrials.gov; ClinicalTrials.gov

  • Healing Breakthrough; Herzog Hospital (Non-profit) · Phase 3 · One trial active, not recruiting (US), and another recruiting (Israel)

    Registry: NCT06117306, NCT06394284 · Source: ClinicalTrials.gov

MDMAAlcohol use disorder

  • US Department of Veterans Affairs (Hospital) · Phase 3 · Phase 2/3, recruiting (with post-traumatic stress disorder)

    Registry: NCT07118839 · Source: ClinicalTrials.gov

MDMAObsessive-compulsive disorder

  • Investigador-promotor (EUA) (University) · Phase 2 · Recruiting

    Registry: NCT05783817 · Source: ClinicalTrials.gov

LSDGeneralised anxiety disorder
LSDMajor depressive disorder
LSDAlcohol use disorder

  • Hospital Universitário de Basileia (investigador-promotor), com a Universidade de Berna (Hospital) · Phase 2 · Recruiting

    Registry: NCT05474989 · Source: ClinicalTrials.gov

LSDDistress in serious illness

  • Hospital Universitário de Basileia (Hospital) · Phase 2 · Recruiting (palliative care)

    Registry: NCT05883540 · Source: ClinicalTrials.gov

DMT and ayahuascaMajor depressive disorder

  • Universidade Federal do Rio Grande do Norte (University) · Phase 2 · One trial completed and another recruiting

    Registry: NCT06094907, NCT07562191 · Source: ClinicalTrials.gov

DMT and ayahuascaGeneralised anxiety disorder

  • Cybin (Helus Pharma) (Company) · Phase 2 · Deuterated analogue (CYB004), completed

    Registry: NCT06051721 · Source: ClinicalTrials.gov

DMT and ayahuascaTreatment-resistant depression

  • GH Research (Company) · Phase 2 · Inhaled 5-MeO-DMT (GH001): phase 2b completed in 2025; the sponsor has announced phase 3, not yet registered

    Registry: NCT05800860, 2023-510047-37-00 · Source: ClinicalTrials.gov; GH Research

EsketamineTreatment-resistant depression

  • Janssen (Johnson & Johnson) (Company) · Approved · Approved medicine (EU and US, 2019); comparative phase 3 trial completed with sites in Portugal · with a site in Portugal

    Registry: NCT04338321 · Source: EMA; ClinicalTrials.gov

Phase 2/3 trials count as phase 3. Results announced by companies without peer-reviewed publication are labelled as such.

And in Portugal?

In Portugal, the status of each substance (approved medicine, in clinical trials or not permitted) is explained in detail on its own page.

Psychedelics in Portugal: what is legal

The substances, one by one

Frequently asked questions

Is psilocybin an approved medicine anywhere?

No. As of 12 November 2026 no psilocybin medicine holds a marketing authorisation. Medical access outside such an authorisation exists, for example, in Switzerland, the Czech Republic, Germany (compassionate use), New Zealand, Canada and Australia. In the United States, the first marketing application was submitted to the FDA on 9 November 2026.

Has the European Medicines Agency approved any psychedelic?

It approved esketamine nasal spray in 2019, for treatment-resistant depression in adults, together with an antidepressant. It has not approved psilocybin, MDMA, LSD or DMT. In 2024 it held a meeting on the regulatory framework for these substances in the European Union.

What is special or compassionate access?

It is the medical use of a substance without a marketing authorisation, allowed case by case: an authorised doctor requests it for a specific patient when alternatives have failed. It exists, for example, in Switzerland (federal health office licences), Germany (a compassionate-use programme) and the Czech Republic (since January 2026).

Are psilocybin or MDMA permitted in Portugal?

No. They remain prohibited: they are in Table II-A of Decree-Law 15/93, and producing, selling or supplying them is a crime. Since 2001, possession for personal use has been an administrative offence rather than a crime, but that does not make them permitted. One phase 2 clinical trial of psilocybin is authorised in Portugal.

Are DMT and ayahuasca legal anywhere?

DMT is controlled under the 1971 United Nations Convention. Religious use of ayahuasca, which contains DMT, is recognised in Brazil by a 2010 resolution and, in the United States, for one church, by a 2006 Supreme Court decision. In clinical trials, DMT and 5-MeO-DMT are at phase 2.

Where are psychedelic clinical trials most advanced?

In the United States. Psilocybin for treatment-resistant depression has had a marketing application at the FDA since November 2026; LSD has three phase 3 trials that met their primary endpoint, according to the sponsor; MDMA for post-traumatic stress disorder was not approved in 2024. In Portugal there is one phase 2 trial of psilocybin in palliative care.

How this page is made

Every row was confirmed on primary sources: regulators’ websites (FDA, EMA, TGA and others), published legislation, ClinicalTrials.gov, the EU clinical trials register (CTIS) and official announcements.

Anything that could not be confirmed on a primary source was left out. Results announced by companies without peer-reviewed publication are labelled as such.

This information is educational. It does not constitute a treatment recommendation or advertising of medicines.

Sources

109
  1. EUDA / INCB. Green List: psychotropic substances under international control (1971 Convention), 36th edition, 2025. euda.europa.eu Checked 12 November 2026
  2. OMS / WHO ECDD. Expert Committee on Drug Dependence, 36th report (2014): recommendation not to place ketamine under international control. unodc.org Checked 12 November 2026
  3. EMA. European public assessment report for esketamine nasal spray; authorised in the EU since 18 December 2019. ema.europa.eu Checked 12 November 2026
  4. INFARMED. Public funding assessment report for esketamine in treatment-resistant depression (approved 7 May 2025). infarmed.pt Checked 12 November 2026
  5. Diário da República. Law 30/2000 of 29 November: the legal regime for drug use (decriminalisation, in force since 1 July 2001). diariodarepublica.pt Checked 12 November 2026
  6. Diário da República. Law 55/2023 of 8 September: amends Decree-Law 15/93 and Law 30/2000 (in force since 1 October 2023). files.diariodarepublica.pt Checked 12 November 2026
  7. Diário da República. Law 19-F/2026 of 8 May: amends Decree-Law 15/93 and republishes Tables I-A, II-A, IV and V (psilocybin, psilocin, MDMA, LSD and DMT in Table II-A; ketamine is not listed). files.diariodarepublica.pt Checked 12 November 2026
  8. CTIS (UE). Trial 2023-510488-36-01 (PsyPal): authorised in Portugal on 25 November 2024. euclinicaltrials.eu Checked 12 November 2026
  9. ClinicalTrials.gov. NCT06782724 (PsyPal), psilocybin in palliative care. clinicaltrials.gov Checked 12 November 2026
  10. Sbírka zákonů (CZ). Government Regulation 552/2025 Coll., medical use of psilocybin (in force 1 January 2026). epravo.cz Checked 12 November 2026
  11. NUDZ (CZ). National Institute of Mental Health: statement on the availability of psilocybin treatment (23 March 2026). nudz.cz Checked 12 November 2026
  12. BfArM (DE). List of active compassionate-use programmes: psilocybin in treatment-resistant depression. bfarm.de Checked 12 November 2026
  13. BAG / OFSP (CH). Exceptional licences for banned narcotics (‘limited medical use’). bag.admin.ch Checked 12 November 2026
  14. BAG / OFSP (CH). Expert report for the FOPH on limited medical use of hallucinogens and MDMA, 2nd edition, 2025 (2024 data). bag.admin.ch Checked 12 November 2026
  15. Tweede Kamer (NL). Government response to the State Commission on MDMA, Parliamentary Paper 24 077 no. 557 (17 June 2025). zoek.officielebekendmakingen.nl Checked 12 November 2026
  16. wetten.overheid.nl. Opium Act (Opiumwet), Lists I and II, consolidated version. wetten.overheid.nl Checked 12 November 2026
  17. legislation.gov.uk. Misuse of Drugs Regulations 2001, Schedule 1. legislation.gov.uk Checked 12 November 2026
  18. UK Parliament. Home Office written answer on the scheduling of psilocybin (27 October 2026). questions-statements-api.parliament.uk Checked 12 November 2026
  19. Lovdata (NO). Narcotics regulation (narkotikaforskriften), list in force since 1 September 2026. lovdata.no Checked 12 November 2026
  20. IMPO (UY). Decree-Law 14.294, article 31, as worded by Law 19.889 (2020). impo.com.uy Checked 12 November 2026
  21. CONAD / gov.br. CONAD Resolution 1 of 25 January 2010 (religious use of ayahuasca). gov.br Checked 12 November 2026
  22. Supremo Tribunal dos EUA (LII). Gonzales v. O Centro Espírita Beneficente União do Vegetal, 546 U.S. 418 (2006). law.cornell.edu Checked 12 November 2026
  23. Oregon Health Authority. Oregon Psilocybin Services (Measure 109, ORS 475A). oregon.gov Checked 12 November 2026
  24. Oregon Health Authority. Psilocybin service centre licence: requirements for clients and operators. oregon.gov Checked 12 November 2026
  25. Colorado General Assembly. SB23-290, Natural Medicine Regulation and Legalization (in force 1 July 2023). leg.colorado.gov Checked 12 November 2026
  26. Council of the District of Columbia. D.C. Law 23-268, Entheogenic Plant and Fungus Policy Act of 2020. code.dccouncil.gov Checked 12 November 2026
  27. Compass Pathways. Announcement of 9 November 2026: COMP360 psilocybin New Drug Application to the FDA completed, in treatment-resistant depression; the FDA has not yet announced acceptance. ir.compasspathways.com Checked 12 November 2026
  28. GH Research. Announcement of 5 January 2026: the FDA lifts the clinical hold on GH001. globenewswire.com Checked 12 November 2026
  29. ClinicalTrials.gov. API v2 query on 12 November 2026 (interventional studies; ‘ongoing’ = recruiting, not yet recruiting, active or by invitation). clinicaltrials.gov Checked 12 November 2026
  30. ClinicalTrials.gov. NCT05711940 (COMP006), psilocybin in treatment-resistant depression, phase 3. clinicaltrials.gov Checked 12 November 2026
  31. ClinicalTrials.gov. NCT03775200, psilocybin in treatment-resistant depression, phase 2 (site in Portugal). clinicaltrials.gov Checked 12 November 2026
  32. ClinicalTrials.gov. NCT07226232, psilocybin in treatment-resistant depression, phase 3. clinicaltrials.gov Checked 12 November 2026
  33. ClinicalTrials.gov. NCT06308653 (uAspire), psilocybin in major depressive disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  34. ClinicalTrials.gov. NCT06564818 (APPROACH), CYB003 in major depressive disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  35. ClinicalTrials.gov. NCT06793397 (EMBRACE), CYB003 in major depressive disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  36. ClinicalTrials.gov. NCT07570654, psilocybin in post-traumatic stress disorder, phase 2/3. clinicaltrials.gov Checked 12 November 2026
  37. ClinicalTrials.gov. NCT07638553, psilocybin in alcohol use disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  38. ClinicalTrials.gov. NCT05398484, psilocybin in advanced cancer, phase 2/3. clinicaltrials.gov Checked 12 November 2026
  39. ClinicalTrials.gov. NCT05481736, psilocybin in anorexia nervosa, phase 2. clinicaltrials.gov Checked 12 November 2026
  40. ClinicalTrials.gov. NCT04077437 (MAPP2), MDMA in post-traumatic stress disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  41. ClinicalTrials.gov. NCT06117306, MDMA in post-traumatic stress disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  42. ClinicalTrials.gov. NCT07118839, MDMA in post-traumatic stress disorder with alcohol use disorder, phase 2/3. clinicaltrials.gov Checked 12 November 2026
  43. ClinicalTrials.gov. NCT05783817, MDMA in obsessive-compulsive disorder, phase 2. clinicaltrials.gov Checked 12 November 2026
  44. ClinicalTrials.gov. NCT06741228 (Voyage), LSD in generalised anxiety disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  45. ClinicalTrials.gov. NCT06809595 (Panorama), LSD in generalised anxiety disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  46. ClinicalTrials.gov. NCT06941844 (Emerge), LSD in major depressive disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  47. ClinicalTrials.gov. NCT07592689 (Ascend), LSD in major depressive disorder, phase 3. clinicaltrials.gov Checked 12 November 2026
  48. ClinicalTrials.gov. NCT05474989, LSD in alcohol use disorder, phase 2. clinicaltrials.gov Checked 12 November 2026
  49. ClinicalTrials.gov. NCT05883540, LSD in palliative care, phase 2. clinicaltrials.gov Checked 12 November 2026
  50. ClinicalTrials.gov. NCT07562191, DMT in major depressive disorder, phase 2. clinicaltrials.gov Checked 12 November 2026
  51. ClinicalTrials.gov. NCT06051721, CYB004 in generalised anxiety disorder, phase 2. clinicaltrials.gov Checked 12 November 2026
  52. ClinicalTrials.gov. NCT05800860, 5-MeO-DMT (GH001) in treatment-resistant depression, phase 2b. clinicaltrials.gov Checked 12 November 2026
  53. ClinicalTrials.gov. NCT04338321, esketamine versus quetiapine in treatment-resistant depression, phase 3 (sites in Portugal). clinicaltrials.gov Checked 12 November 2026
  54. FDA. Drugs@FDA, application 211243 (esketamine nasal spray): approved 5 March 2019, with later supplements. accessdata.fda.gov Checked 12 November 2026
  55. FDA. Esketamine prescribing information revised January 2025 (monotherapy in treatment-resistant depression). accessdata.fda.gov Checked 12 November 2026
  56. FDA. Press announcement of 24 April 2026: national priority vouchers for treatments of serious mental illness. fda.gov Checked 12 November 2026
  57. Health Canada. Requests to the Special Access Program for psychedelic-assisted psychotherapy. canada.ca Checked 12 November 2026
  58. Health Canada. Subsection 56(1) class exemption for activities with psilocybin and MDMA authorised under the Special Access Program. canada.ca Checked 12 November 2026
  59. TGA (Austrália). Media release of 3 February 2023: from 1 July 2023, authorised psychiatrists may prescribe MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression. tga.gov.au Checked 12 November 2026
  60. Medsafe (NZ). Guideline on applications for approval to prescribe psychedelics, version 1.0 (24 July 2025). medsafe.govt.nz Checked 12 November 2026
  61. Medsafe (NZ). Psychedelics: information for health professionals. medsafe.govt.nz Checked 12 November 2026
  62. FDA. Final summary minutes of the Psychopharmacologic Drugs Advisory Committee on midomafetamine (MDMA), 4 June 2024. fda.gov Checked 12 November 2026
  63. FDA. Complete response letter for NDA 215455 (midomafetamine), 8 August 2024. download.open.fda.gov Checked 12 November 2026
  64. Lykos Therapeutics. Announcement of 9 August 2024: FDA complete response letter for midomafetamine in post-traumatic stress disorder. prnewswire.com Checked 12 November 2026
  65. ClinicalTrials.gov. NCT07584720, midomafetamine in healthy adults, phase 1 (2026). clinicaltrials.gov Checked 12 November 2026
  66. Definium Therapeutics. Announcement of 22 June 2026: topline results of the phase 3 Emerge trial (LSD, major depressive disorder); not peer reviewed. ir.definiumtx.com Checked 12 November 2026
  67. Definium Therapeutics. Announcement of 12 August 2026: topline results of the phase 3 Voyage trial (LSD, generalised anxiety disorder); not peer reviewed. ir.definiumtx.com Checked 12 November 2026
  68. Definium Therapeutics. Announcement of 14 September 2026: topline results of the phase 3 Panorama trial (LSD, generalised anxiety disorder); not peer reviewed. ir.definiumtx.com Checked 12 November 2026
  69. INFARMED (Infomed). Infomed: ketamine medicines authorised in Portugal (search by INN “cetamina”): solution for injection, anaesthetic indication, restricted prescription for hospital use only. extranet.infarmed.pt Checked 12 November 2026
  70. INFARMED. Guidance on off-label use of medicines (March 2025). infarmed.pt Checked 12 November 2026
  71. Canada Gazette. Controlled Substances Regulations (SOR/2025-242), in force 1 October 2026: they incorporate the authorisation to provide psilocybin and MDMA to patients through the Special Access Program. gazette.gc.ca Checked 12 November 2026
  72. Health Canada. Regulatory Decision Summary RDS00738: esketamine nasal spray in treatment-resistant major depressive disorder (decision of 20 May 2020). dhpp.hpfb-dgpsa.ca Checked 12 November 2026
  73. Health Canada. Regulatory Decision Summary RDS00895: indication extended to major depressive disorder requiring urgent psychiatric care (decision of 2 September 2021). dhpp.hpfb-dgpsa.ca Checked 12 November 2026
  74. Canada's Drug Agency (antiga CADTH). Final expert-committee recommendation SR0621: esketamine should not be reimbursed for major depressive disorder in adults (December 2020). cda-amc.ca Checked 12 November 2026
  75. ANVISA / Diário Oficial da União. Resolution RE 4,413 of 29 October 2020: registration of esketamine nasal spray as a new medicine. in.gov.br Checked 12 November 2026
  76. ANVISA. New medicines and indications: registration of esketamine hydrochloride and approved indications (November 2020). gov.br Checked 12 November 2026
  77. Instituto de Salud Pública de Chile. Registry record F-26406/26 (esketamine nasal spray): registered on 8 November 2021, with the current indication. The page only opens after a search in the registry. registrosanitario.ispch.gob.cl Checked 12 November 2026
  78. Instituto de Salud Pública de Chile. Approved professional information leaflet (registration F-26406/21): treatment-resistant depression in adults. ispch.cl Checked 12 November 2026
  79. ANMAT. Disposition 3031/2021: new approved leaflet for esketamine nasal spray (certificate 59,173), with the indications. boletin.anmat.gob.ar Checked 12 November 2026
  80. ANMAT. List of authorisations, August 2020 (certificate 59,173, esketamine 28 mg nasal spray). anmat.gob.ar Checked 12 November 2026
  81. Swissmedic. Medicines with new active substances: esketamine nasal spray, authorisation no. 67103 of 25 February 2020. swissmedic.ch Checked 12 November 2026
  82. Swissmedic. Public summary of the assessment report (SwissPAR): indication extended on 27 August 2021 (severe depressive episodes, psychiatric emergency). swissmedic.ch Checked 12 November 2026
  83. SAHPRA. Approved professional information for esketamine nasal spray: registration no. 53/1.2/0732, first authorised on 6 April 2022. pi-pil-repository.sahpra.org.za Checked 12 November 2026
  84. MFDS (Coreia do Sul). Medicine record 202004585 (esketamine nasal spray): approved on 23 June 2020, with indications. nedrug.mfds.go.kr Checked 12 November 2026
  85. TFDA (Taiwan). Import licence no. 028215 (esketamine nasal spray): issued on 13 January 2022, with indications. mcp.fda.gov.tw Checked 12 November 2026
  86. TGA. ARTG 311827 public summary (esketamine nasal spray): start date 9 March 2021, with the indication. ebs.tga.gov.au Checked 12 November 2026
  87. PBS (Governo da Austrália). Medicine status: esketamine for treatment-resistant depression, recommended in December 2024 and listed on the PBS on 1 May 2025. pbs.gov.au Checked 12 November 2026
  88. MHRA (gov.uk). Great Britain marketing authorisations for centrally authorised products: list of PLGB numbers (esketamine 28 mg nasal spray, PLGB 00242/0648). gov.uk Checked 12 November 2026
  89. MHRA (gov.uk). Guidance: conversion of centrally authorised products into UK marketing authorisations on 1 January 2021. gov.uk Checked 12 November 2026
  90. NICE. Technology appraisal TA854: esketamine nasal spray for treatment-resistant depression, not recommended (14 December 2022). nice.org.uk Checked 12 November 2026
  91. Scottish Medicines Consortium. Advice SMC2258: esketamine accepted for use in NHSScotland for treatment-resistant depression (7 September 2020). scottishmedicines.org.uk Checked 12 November 2026
  92. Scottish Medicines Consortium. Advice SMC2539: esketamine not recommended as acute treatment in a psychiatric emergency (7 November 2022). scottishmedicines.org.uk Checked 12 November 2026
  93. Statens legemiddelverk (Noruega). Rapid assessment ID2019_116 of esketamine in treatment-resistant depression, quoting the Norwegian indication (November 2020). nyemetoder.no Checked 12 November 2026
  94. Nye metoder (Noruega). Method ID2019_116: esketamine for treatment-resistant depression, not introduced (decisions of 2021 and 18 October 2022). nyemetoder.no Checked 12 November 2026
  95. Nye metoder (Noruega). Method ID2020_042: esketamine for a psychiatric emergency, not to be used (2024). nyemetoder.no Checked 12 November 2026
  96. Beslutningsforum for nye metoder (Noruega). Approved minutes of the meeting of 25 August 2025, case 119-2025 (ID2022_018): ketamine for treatment-resistant depression. nyemetoder.no Checked 12 November 2026
  97. Nye metoder (Noruega). Method ID2022_018: intravenous ketamine for treatment-resistant depression (decision taken). nyemetoder.no Checked 12 November 2026
  98. Ministério da Saúde de Singapura (formulário nacional). National Drug Formulary, product SIN16033P (esketamine nasal spray): approved indications. ndf.gov.sg Checked 12 November 2026
  99. Ministério da Saúde de Singapura. Parliamentary reply of 5 February 2025: nasal spray approved in October 2020 by the Health Sciences Authority. moh.gov.sg Checked 12 November 2026
  100. VA / DoD (EUA). Clinical practice guideline for the management of major depressive disorder, version 4.0 (February 2022), recommendations 12 and 19. healthquality.va.gov Checked 12 November 2026
  101. BÄK, KBV e AWMF (programa NVL). National care guideline for unipolar depression, version 3.2, recommendation 7-25 and section 12.3.6 (intravenous ketamine). leitlinien.de Checked 12 November 2026
  102. Ministério da Saúde da Malásia (MaHTAS). Clinical practice guideline for major depressive disorder, 2nd edition (2019), recommendation 9 (intravenous ketamine). mymahtas2.moh.gov.my Checked 12 November 2026
  103. INESSS (Quebeque). Bulletin of 2 June 2026: intravenous ketamine as acute adjunctive treatment of refractory depression in adults, optimal-use conditions and clinical tools. inesss.qc.ca Checked 12 November 2026
  104. CANMAT (Canadian Journal of Psychiatry). CANMAT 2023 update on clinical guidelines for major depressive disorder in adults (published 2024), table 7.2. pmc.ncbi.nlm.nih.gov Checked 12 November 2026
  105. RANZCP. Professional Practice Guideline 24: use of ketamine in psychiatric practice (2025). ranzcp.org Checked 12 November 2026
  106. Duodecim e Associação Psiquiátrica Finlandesa. National treatment recommendation for depression (25 June 2026). kaypahoito.fi Checked 12 November 2026
  107. ÖGPB (Áustria). Consensus statement on the diagnosis and treatment of treatment-resistant depression (2021). universimed.com Checked 12 November 2026
  108. Indian Psychiatric Society (Indian Journal of Psychiatry). Clinical practice guidelines for depression (2026), table 12. pmc.ncbi.nlm.nih.gov Checked 12 November 2026
  109. Health Canada (Drug Product Database). Product monograph of esketamine nasal spray, section 1: indications. pdf.hres.ca Checked 12 November 2026

The first step is an assessment consultation.

We answer your questions and assess with you whether this approach is suitable. Send a request and we will contact you to arrange it.

Request an assessment consultation

If you prefer, contact us: