In brief
- The Australian Therapeutic Goods Administration (TGA) has eased the conditions of the world’s only program allowing the prescription of psilocybin and MDMA outside of clinical trials.
- The authorized psychiatrist is no longer required to remain for the entire session; they may leave after administering the substance if an accredited therapist remains with the patient, along with a second team member.
- By the end of 2025, 65 people had accessed psilocybin and 123 had accessed MDMA with no reported adverse events; the psychiatrists’ college has criticized the change.
Australia remains the most closely watched regulatory laboratory in the world in this field: since July 2023, it has been the only country where an authorized psychiatrist can prescribe psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder outside of a clinical trial. Three years later, the regulator has reviewed the program’s rules and loosened the very requirement that generated the most debate.
What exactly is changing
Until now, the authorized psychiatrist was required to remain in the room during the entire dosing session, which can last several hours. With the revision by the Therapeutic Goods Administration, the psychiatrist remains the clinical lead and must be present at the time of administration, but may leave the room afterward provided that an accredited therapist—a clinical psychologist, doctor, nurse, or occupational therapist—remains with the patient, accompanied by a second team member. The analysis of this measure is signed by Thileepan Naren, Myfanwy Graham, and Suzanne Nielsen, researchers from Monash and Curtin universities.
A short but clean track record
The cumulative figures remain modest. By the end of 2025, 65 people had accessed psilocybin therapy and 123 had accessed MDMA therapy: 188 patients in total, with no reported adverse events. The authors themselves qualify this data with honesty: the absence of incidents may be due as much to the safety of the procedure as to the strict screening used to select who enters the program. The Royal Australian and New Zealand College of Psychiatrists, the country’s professional body, has publicly criticized the removal of the requirement for the psychiatrist’s continuous physical presence, although it acknowledges that some of the clinical trials that supported the original approval did not require it either.
What it implies
The interesting thing about the Australian case is not so much the measure itself as the type of discussion it has opened: the tension between facilitating access and maintaining maximum caution, with the regulator pulling in one direction and the professional college in the other. This is exactly the debate that every country studying similar pathways will have to resolve, which is why it is worth following the program’s evolution closely. Making logistical requirements more flexible does not necessarily mean less safety if clear selection and emergency response protocols are maintained; what this update provides, above all, is that there is now real-world data on continued use in an ordinary healthcare framework, something that until recently only existed within the bubble of clinical trials. In Europe, the path is slower: a few days ago we reported on how Czechia legalized medical psilocybin while actual access remains pending. You can expand on the context in our Psychedelics Guide.
Source
- Naren T, Graham M, Nielsen S. MDMA and psilocybin therapy rules have been relaxed. Here’s what might happen next. The Conversation, June 29, 2026.
Educational content written from a harm reduction perspective and with respect for individual freedom. It is not a substitute for advice from a healthcare professional and is not intended to encourage or condemn any drug use.
