In March 2022 Mind Medicine Australia lodged new applications with the TGA for the restrictive rescheduling of the medical use of MDMA and psilocybin as part of therapy in medically controlled environments from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines) of the Poisons Standard.
In February 2023 the TGA approved Mind Medicine Australia’s application to reschedule the substances psilocybin and MDMA from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines) of the Poisons Standard. With this rescheduling, psychiatrists who have the requisite approvals are now able to utilise psilocybin for treatment-resistant depression and MDMA for PTSD. These changes came into effect July 1st, 2023.
This groundbreaking decision makes Australia the first country in the world to reschedule these medicines, and everyone at MMA would like to extend our deepest gratitude to everyone who took part in this process and helped to make it happen.
Mind Medicine Australia has continued its advocacy work, collaborating with the End Wise coalition to submit a rescheduling application in March 2025 to expand the use of psilocybin to include existential distress towards end-of-life.
The Australia Story
An article published in the British Journal of Pharmacology written by Professor David Nutt, Professor Paul Fitzgerald, Dr Anne Schlag and Peter Hunt AM, which explains MMA’s role in the rescheduling process in detail – Nutt, D. J., Hunt, P., Schlag, A. K., & Fitzgerald, P. (2024). The Australia story: Current status and future challenges for the clinical applications of psychedelics. British Journal of Pharmacology.
Vanessa’s important message to the Prime Minister of Australia
Please see Vanessa and Franco’s Story on this short video and Vanessa’s Letter to the PM:
Our Successful Rescheduling Applications for the Medical Use of Psilocybin and MDMA:
Successful Rescheduling Applications for the Medical Use of Psilocybin
These were lodged with the TGA in March 2022 and can be found here.
Successful Rescheduling Applications for the Medical Use of MDMA
These were lodged with the TGA in March 2022 and can be found here.
The TGA's Final Decision to Reschedule MDMA and Psilocybin
The TGA's Final Decision to Reschedule MDMA and Psilocybin
The TGA Announced its Final Decision to Reschedule on 3 February 2023.
Our Media Release in response to the TGA Final Decision
Breaking News: The TGA Announces the Delegate’s Final Decision to Reschedule the Use of Psilocybin and MDMA for Medical Purposes
Read our media release here - 3 February 2023
The TGA’s Interim Decisions against Rescheduling
The TGA’s Interim Decisions against Rescheduling
The TGA Announced its Interim Decisions against Rescheduling on 21 October 2022.
Our Media Release in response to the TGA Interim Decision:
Use of Psychedelic Therapies for Treatment Resistant Patients Again Rejected by Government, Despite Strong Supporting Safety and Efficacy Data and Australia’s Worsening Mental Health Crisis
Read our media release here - 28 October, 2022
Our Submission in Response to the TGA Interim Submission 2022:
Our Submission in Response to the TGA Interim Submission 2022
Submission Opposing the Interim Decisions not to amend the Poisons Standard in Relation to the Restricted Medical Use of MDMA and Psilocybine.
2025 Rescheduling Application - Psilocybin for Existential Distress Nearing End of Life
The Rescheduling Application Submitted by End Wise in Collaboration with Mind Medicine Australia
Mind Medicine Australia collaborated with The End Wise Coalition to submit an application to expand the use of psilocybin to include existential distress towards end-of-life.
2026 AP Scheme Update — A Result of Mind Medicine Australia's Advocacy
TGA Extends Therapists Who Can Assist with Dosing
In May 2026, the TGA released more flexible requirements for the delivery of MDMA and psilocybine-assisted therapies for patients with PTSD and treatment-resistant depression. The changes broaden the range of therapists who can deliver psychedelic-assisted therapy, confirm that the prescribing psychiatrist does not need to remain in the room for the full dosing session, and confirm that dosing sessions can occur in a clinic rather than a hospital, provided it is within 15 minutes of an emergency department. Mind Medicine Australia is proud to have advocated for these changes, with the support of the many clinics and clinicians working in this space.
Our Submission to the TGA Review of the Authorised Prescriber Scheme
Mind Medicine Australia's formal submission to the TGA in response to the targeted consultation on the review of the Authorised Prescriber scheme for access to MDMA and psilocybine — submitted 6 August 2025 by Chairman and Co-Founder Peter Hunt AM