Authorised Prescriber Scheme for psilocybin and MDMA - data reporting

Question

1. What is the status of the TGA's review into the operation of the Authorised Prescriber Scheme in relation to the use of psilocybin assisted therapy for treatment resistant depression and MDMA assisted therapy for post-traumatic stress disorder? a. Given submissions closed in August 2025, why has the review not yet been published? 2. When will the findings of the review be released publicly? 3. Has the TGA considered recommending or encouraging prescribing psychiatrists to submit real-world treatment outcomes to the Australian National University (ANU) registry as an important way of understanding efficacy and safety issues? 4. Why has the TGA not adopted language similar to the Department of Veterans' Affairs (DVA), which actively encourages prescribing psychiatrists to submit treatment outcomes data to the ANU Registry? 5. Does the TGA agree that independent registry data may provide more comprehensive real-world evidence than the TGA's limited six-monthly reporting requirements? 6. If so, why is such data not explicitly encouraged by the TGA in its Authorised Prescriber guidance materials? 7. Has the TGA assessed whether greater uptake of registry-based reporting would improve pharmacovigilance and clinical knowledge?

Answer

Please see attached answer.

Documents

• Question with answer (PDF) (opens in a new tab)
• DHDA SQ26-002763.pdf (opens in a new tab)