MDMA and Psilocybin-Assisted Therapy in Australia: Early Real-World Prescribing, Safety Monitoring and Regulatory Developments
Abstract
Australia became the first country to establish a national regulatory pathway permitting authorised psychiatrists to prescribe 3,4-methylenedioxymethamphetamine (MDMA) for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression (TRD) through the Therapeutic Goods Administration (TGA) Authorised Prescriber Scheme. Two and a half years after implementation, psychedelic-assisted therapy (PAT) has transitioned from regulatory reform to clinical practice. Freedom of Information (FOI) data indicate that by 30 June 2025 there were 20 active MDMA Authorised Prescriber approvals and 17 active psilocybin Authorised Prescriber approvals. By 31 December 2025, these numbers had increased to 48 and 40 authorised prescribers respectively, representing growth of 140% for MDMA and 135% for psilocybin within six months. During the period from 1 July 2023 to 31 December 2025, 123 patients were reported to have received MDMA-assisted therapy and 65 patients psilocybin-assisted therapy. Despite rapid growth, authorised prescribers represent approximately 1% of Australia's estimated psychiatric workforce. While these data suggest increasing acceptance of PAT within Australian psychiatry, implementation remains at an early stage. Continued attention to governance, competency-based training, supervision, safety monitoring and outcome evaluation will be essential as access expands and PAR becomes increasingly integrated into psychiatric practice.
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