In brief
- The TGA, Australia’s drug regulator, has revised the rules for its program allowing the prescription of MDMA and psilocybin.
- The most visible change: psychiatrists are no longer required to remain in the room for the entire session after administering the substance.
- By the end of 2025, 65 people had accessed psilocybin therapy and 123 had accessed MDMA therapy, with no officially reported adverse events.
The Therapeutic Goods Administration (TGA) has published a revision of the requirements for the “Authorized Prescriber” scheme, which since 2023 has allowed for the prescription of MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression in Australia. Following months of consultations with clinicians and working groups within the psychiatric profession, the agency has eased several requirements that practitioners themselves argued were hindering real-world access to these therapies.
Psychiatrists no longer required to remain in the room
The most significant change concerns the physical presence of the psychiatrist during the administration session. Previously, regulations required the specialist to remain in the room for the entire duration of the substance’s effects. Under the revision, the psychiatrist may administer the dose, ensure that everything is proceeding normally, and then leave the room, delegating direct supervision to a second professional—such as a clinical psychologist, medical doctor, mental health nurse, or occupational therapist—who must remain with the patient throughout the session.
More flexibility for training and treatment settings
The TGA has also redefined how it accredits the competence of psychiatrists who wish to prescribe these substances. They must now demonstrate previous experience in clinical trials involving psychedelic-assisted therapy or undergo training supervised by another authorized prescriber with relevant experience, using the standards of the Royal Australian and New Zealand College of Psychiatrists (RANZCP) as a benchmark. Furthermore, it is no longer mandatory for treatment to take place in a hospital; it is sufficient for the facility to have emergency resuscitation capabilities, secure storage for the substance, rescue medication on hand, and proximity—less than 15 minutes—to an emergency department. The agency notes that this flexibility aims to improve access in rural areas and for Aboriginal and Torres Strait Islander communities, who previously faced greater difficulties reaching authorized hospital facilities.
What this implies
The data held by the TGA through the end of 2025—65 people treated with psilocybin and 123 with MDMA, with no officially reported adverse events—represents a small sample in a highly controlled context with strict patient selection and specifically trained teams; it does not allow for broad conclusions regarding large-scale safety. The Royal Australian and New Zealand College of Psychiatrists has expressed reservations about removing the psychiatrist’s continuous presence, noting that the clinical trials supporting current evidence included safeguards that will no longer be mandatory in private practice. Proponents of the change argue that overly rigid regulations ultimately push people toward the unregulated market, where substances of unknown purity and dosage are common. Both perspectives are legitimate: the evidence regarding efficacy remains, according to the literature itself, limited and mixed, and this regulatory adjustment is primarily a matter of organizing already-authorized access rather than a new approval of efficacy.
Source
- Medical Xpress. Australia relaxes psychedelic therapy oversight despite limited safety evidence. Medical Xpress, June 30, 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.
