AustraliaClinical trials

A psychiatrist in Australia can prescribe psilocybin, for exactly one condition.

Since 1 July 2023 a specialist psychiatrist in Australia can prescribe psilocybin for treatment-resistant depression, and for nothing else. Each of those psychiatrists holds their own approval.

Analysis · Finding · By Allan Kerr · Checked 9 September 2026

The short answer

Since when. Psilocybin has been lawfully prescribable in Australia since 1 July 2023.

For what. One condition: treatment-resistant depression. Every other use stays in Schedule 9.

By whom. A specialist psychiatrist holding a personal authority under the Therapeutic Goods Act 1989. That authority attaches to one doctor, and clinics and professions do not hold it.

What is prescribed. No psilocybine product is on the Australian Register of Therapeutic Goods, so every prescription is for an unapproved good, supplied under an import licence and a permit for each consignment.

How many people have had it. Every prescriber reports patient numbers to the regulator every six months. The regulator has published none of them on its own initiative.

Who can prescribe it, and what is there to prescribe?

A psychiatrist prescribing psilocybin in Australia is doing it on a personal approval, and it has to be a specialist psychiatrist. The authority sits in subsection 19(5) of the Therapeutic Goods Act 1989, with Appendix D clause 9 as the narrow limit that admits the supply. A clinic cannot hold it. Neither can a profession. Beyond that authority, supply is lawful to a clinical trial approved by or notified to the Secretary.

There is one condition, and that is the whole list. In the Poisons Standard the substance is spelled psilocybine, and Schedule 8 admits it for treatment-resistant depression alone, with everything else left in Schedule 9. If you are asking whether another diagnosis qualifies, the Standard does not provide for one.

Which raises the question of what there is to prescribe, because the regulator that licenses the prescribing does not control the supply. As for making it here, the Office of Drug Control says it has no power, under Commonwealth law, to permit psilocybin synthesis or mushroom cultivation in Australia. So a prescriber’s supply depends on an import licence, with a permit for each consignment.

No psilocybine product is on the Australian Register of Therapeutic Goods, as of the August 2026 review of Australia’s entry in the register.

How many people have had it?

The regulator holds the number and has not published it. Every authorised prescriber reports patient numbers to the Therapeutic Goods Administration every six months. Every prescriber or patient number in the public record arrived through the TGA’s freedom-of-information disclosure log.

Every psilocybin prescribing release on the public record, transcribed from the TGA’s own disclosure logSeven rows, grouped by the two disclosure-log pages they sit in. Four releases fall in the log for July 2025 to June 2026: 6 February 2026, reference 26-2560, Authorised Prescriber data for MDMA/Psilocybin; 19 December 2025, reference 26-2468, Authorised Prescriber approvals and quarterly usage reports for 1 July 2023 to 28 November 2025; 9 October 2025, reference 26-2177, data relating to prescribed MDMA and psilocybine; 24 July 2025, reference 25-0233, Special Access Scheme and Authorised Prescriber data for 1 July 2023 to 30 June 2025. Three fall in the log for July 2024 to June 2025: 26 May 2025, reference 25-0186; 6 March 2025, reference 25-0139, approvals and rejections; 16 August 2024, reference FOI 5316. Each description is the TGA’s own wording. The released files themselves have not been read.The disclosure log, transcribedSeven releases · Aug 2024 to Feb 2026 · two log pagesDisclosure log, July 2025 to June 20266 February 202626-2560Authorised Prescriber (AP) data for MDMA/Psilocybin.19 December 202526-2468Authorised Prescriber Approvals (MDMA & Psilocybin) and AuthorisedPrescriber Quarterly Usage Reports 1 July 2023 to 28 November 2025.9 October 202526-2177Data relating to prescribed MDMA and Psilocybine.24 July 202525-0233Special Access Scheme and Authorised Prescriber data forMDMA/psilocybin for the period 1 July 2023 to 30 June 2025.Disclosure log, July 2024 to June 202526 May 202525-0186Authorised Prescriber and Special Access Scheme data for MDMA andpsilocybin for the period 1 July 2023 to 30 April 2025.6 March 202525-0139Approvals and rejections given by the TGA to use MDMA and psilocybinunder the Authorised Prescriber Scheme.16 August 2024FOI 5316Authorised prescriber approvals for Psilocybin and MDMA from 1 July 2023to 30 June 2024Transcribed from the TGA’s disclosure log under section 11C ofthe Freedom of Information Act 1982, read 31 August 2026. Eachdescription is the TGA’s own wording. Two releases were read on1 September 2026 and their figures are in the text. In the 24July 2025 row the reference column reads 25-0233 while the filelink reads FOI 24-0233; recorded as it appears.
Where the figures above came from: every release naming psilocybin, as it appears in the TGA's disclosure log (opens in new tab). The descriptions are the regulator’s own.Transcribed from the Therapeutic Goods Administration, read 31 August 2026. Read 1 September 2026. The figures they contain are in the text above.

Seven releases went out between August 2024 and February 2026, each covering MDMA and psilocybin together. Two of them carry the prescribing figures. This is what they say.

Across every six-monthly report filed for psilocybin through 30 June 2025, prescribers reported 47 new patients. The scheme’s first six months produced none: three reports, no patients. Of the 41 psilocybin report rows in the release, 21 report a total of zero.

Thirty-six prescribers hold an approval to prescribe psilocybin, from 40 applications. Between them they reported those 47 new patients over two years, which is barely more than one each. Every approved application named the same indication, treatment-resistant depression.

A later TGA summary, released in February 2026, counts 40 prescribers and 65 patients. That is a different measure over a different window, and the release does not say how it was aggregated, so the two figures cannot be subtracted from each other.

None of them is a count of people. The TGA’s own caveat on the cannabis version of this return says why: a patient seen under more than one approval, or who changes prescriber, is counted again, and the true patient count is unknown.

Across the whole life of the scheme, from July 2023 to the end of December 2025, the TGA recorded no adverse events reported to it for either drug. That is a fact about the reporting channel. Nothing reached the TGA in two and a half years, and whether anything happened is a question these files do not answer.

Medicinal cannabis sits on the same Authorised Prescriber pathway, with the same six-monthly return. For cannabis the TGA runs an interactive public dashboard. A warning rides on it: that cannabis return cannot be de-duplicated, so by the TGA’s own account the true patient count is unknown. That caveat describes the instrument, and it travels with every psilocybin number above.

The medicinal cannabis dashboard and the caveat printed on it, transcribed from the TGA’s own pageThe TGA’s medicinal cannabis Authorised Prescriber Scheme data page, transcribed. The page describes itself as an interactive dashboard displaying all Authorised Prescriber applications for medicinal cannabis products approved by the TGA. Printed on the same page is the TGA’s own caveat: patient numbers cannot be extrapolated, because a patient prescribed more than one product by the same prescriber is recorded once per approval and a patient who changes prescribers is recorded more than once; the true patient count is unknown; the six-monthly reports contain no patient details allowing duplications to be removed. The same six-monthly reporting instrument covers psilocybin, for which no equivalent page exists.Medicinal cannabis AuthorisedPrescriber Scheme dataThe same pathway · the same six-monthly returnThe page describes itselfThis interactive dashboard displays all Authorised Prescriberapplications for medicinal cannabis products approved by us.The caveat printed on the same pagePatient numbers cannot be extrapolated from thisinformation as patients prescribed more than one productby the same prescriber will be recorded as an entry foreach AP approval. Patients who change prescribers wouldalso be recorded as more than one entry. The true patientcount is unknown. The 6 monthly reports contain no patientdetails to allow for removal of duplications, and we donot collect prescription data.Transcribed verbatim from the TGA’s medicinal cannabis AuthorisedPrescriber Scheme data page, read 31 August 2026. The samesix-monthly reporting instrument covers psilocybin. No equivalentpage exists for it.
What the same regulator publishes for the other substance, and the caveat it prints on the cannabis dashboard page (opens in new tab).Transcribed from the Therapeutic Goods Administration, read 31 August 2026

Small numbers are a fair reason for silence. Per-approval publication could identify individual prescribers, and small-cell suppression is ordinary statistical practice. But the TGA has not made that argument. Nor has it said anything else about why one substance gets a dashboard and the other a filing cabinet, and a request.

How much research is running in Australia?

Our trials corpus held 324 records as of 25 August 2026. Five have an Australian site. All five are industry-sponsored, across three sponsors. One is a patient trial of psilocybin itself, in cancer-related adjustment disorder; two study psilocybin in healthy volunteers; two more test a deuterated psilocin analog for one sponsor’s linked program in major depressive disorder. None of the five is in treatment-resistant depression, which is the one condition the prescribing pathway covers.

Five trials with an Australian site, by condition, and the one condition the prescribing pathway coversSix rows. Five rows each carry a filled mark for one trial with an Australian site: cancer-related adjustment disorder; healthy volunteers, safety and pharmacokinetics; healthy volunteers, safety and pharmacokinetics; major depressive disorder, a deuterated psilocin analog; major depressive disorder, a deuterated psilocin analog. The sixth row is treatment-resistant depression, the one condition the pathway covers, and its mark is an empty outline: no trial sits there. Five trials with an Australian site, of 324 in this register’s corpus, 25 August 2026. Counts are floors: seventeen corpus trials carry no location data.Cancer-related adjustment disorderHealthy volunteers, safety andpharmacokineticsHealthy volunteers, safety andpharmacokineticsMajor depressive disorder, a deuteratedpsilocin analogMajor depressive disorder, a deuteratedpsilocin analogTreatment-resistant depression, the onecondition the pathway coversFive trials with an Australian site, of 324in our corpus, 25 August 2026.Counts are floors: seventeen corpus trialscarry no location data.

One trial is missing from that list, and it happens to be the one the TGA delegate leaned on hardest in the 2026 decision. We probed three times for a phase 2b randomised controlled trial at St Vincent’s Hospital Melbourne and came up empty each time. No site row in the corpus, no linked publication, no occurrence of the name. So these counts are floors, and for a second reason too. Seventeen corpus trials carry no location data.

Has anyone tried to widen it?

Someone has. So far the answer is no. On 29 May 2026 a TGA delegate issued an interim decision that the current scheduling of psilocybine remains appropriate.

As of 28 August 2026, this is where that application stands.

The 2026 application
Interim decision
29 May 2026 · current scheduling remains appropriate
Final decision
none published as of 28 August 2026
Statutory deadline
none
Next check
30 November 2026 · this line carries the outcome when there is one

In 2025 an applicant the TGA records only as private asked for a second Schedule 8 indication: existential distress towards the end of life, prescribed by palliative-care specialists. That class was not clearly defined, the committee found, and it recommended no change. Eleven months passed between the committee taking it up and the interim decision.

Existential distress is not a recognised diagnostic category in DSM-5-TR. The delegate agreed the evidence base was not sufficient, and the committee found the supporting trials small and short of the methodological rigour it expected. On implementation there was no clear pathway, with prescriber credentialling and dispensing controls undefined. Also named was the regulatory impact on state and territory poisons regulators.

Of 595 submissions received, 590 were in support, though only 321 of the 595 included any written component. Both opposing submissions and all three partial ones were written. In opposition, Palliative Care Australia told the consultation the research remains experimental and currently insufficient to support routine use.

The delegate did not close the question, though. Scheduling may be revisited as evidence and diagnostic criteria mature, the delegate recorded, and peak professional bodies not yet heard would be asked before any final decision. Submissions on the interim decision closed on 31 July 2026.

As of 28 August 2026 no final decision has been published. No statutory deadline governs when one must come. We check again on 30 November 2026.

Notes

This page maps what the law permits and what the regulator publishes, and it does not name prescribers or clinics. Describing who may lawfully prescribe is not the same as telling anyone what to do, and none of it is advice.

Whether psilocybin works, and how safe it is, are matters for the trials. On the decision itself, narrowness is the design, and the delegate’s reasoning engages the evidence on its own terms. Treatment-resistant depression, this pathway’s existing indication, is not a standalone DSM-5 diagnosis either, though there is high international agreement on it.

Method and sources

Method. Register row australia(AU-001), status medical, confidence 95, last reviewed 19 August 2026. Corpus as of 25 August 2026; register as of 22 August 2026. Corpus figures are derived from the trials corpus itself, and every count carries its denominator. Absence of published prescribing statistics verified 28 August 2026 across the TGA’s authorised-prescriber pages and freedom-of-information disclosure log; final-decision status verified the same day against the TGA’s final-decisions index and feed. Two FOI releases were read on 1 September 2026 and are the source of every prescribing figure above: 26-2468 (spreadsheet, released 19 December 2025) and 26-2560 (released 6 February 2026). Figures were aggregated over the spreadsheet, never copied from a summary; the counts and their cutoffs are recorded in the piece folder.

Sources. Every claim on this page rests on one of these. All links verified reachable 31 August 2026.

Corrections. Write to corrections@psilocybinlegalization.com. Anything this piece gets wrong is corrected on the page, dated, with the change stated rather than made quietly.

The Psilocybin RecordPsilocybin Media Group
By The Psilocybin Record · corpus as of 25 August 2026 · register as of 22 August 2026 · corrections to corrections@psilocybinlegalization.com
Next check 30 November 2026 · the decision line carries the outcome when there is one