Regulatory landscape
A plain record of how the rules have changed, drawn straight from the Therapeutic Goods Administration. Scrub the timeline to see what changed and when, and follow any item to the official source.
This page reports the regulatory facts as published by the TGA and other authorities. Where AMAPP has published a response, it is clearly marked and kept separate.
The timeline
From this date, psychiatrists authorised by the TGA may prescribe MDMA for post-traumatic stress disorder and psilocybine for treatment-resistant depression. For all other uses, both substances remain Schedule 9.
From this date, the TGA accepts Special Access Scheme and Authorised Prescriber submissions only through the online system.
The Therapeutic Goods Orders setting the quality requirements for MDMA (TGO 112) and psilocybine (TGO 113) take effect.
The TGA's targeted consultation on the Authorised Prescriber scheme for psychedelic-assisted therapies closes to public submissions.
The published outcome sets out four recommendations: psychiatrist experience and competency requirements; the composition of the therapy dyad; the prescriber's on-site presence during administration; and treatment site requirements. These are recommendations and are not yet implemented as regulation.
Official sources
These links open on the TGA website. AMAPP organises them here but does not reproduce or interpret them.
Last reviewed 19 June 2026. Sources are the Therapeutic Goods Administration unless otherwise stated.
