Australia’s approval of MDMA and psilocybin for PTSD and depression is premature, say critics

Abstract

The TGA attached conditions to their use: namely, that onlypsychiatristswhoare trainedandauthorised to prescribe MDMA and psilocybin can do so, that a human research ethics committeemust approve each patient case, and that the treatments must be used in conjunction with psychotherapy.1 An officer of the TGA and the ethics committee must also satisfy themselves that “a suitably robust treatment protocol has been developed.”

In the evidence

This study is part of the evidence base for 2 syntheses in the library. Here is how each one recorded it.

• State of the evidence: MDMA for depression ?Unclear

  Reports that Australia's TGA attached conditions to MDMA and psilocybin use, requiring authorized psychiatrists, ethics committee approval per patient, and use with psychotherapy, with critics calling the approval premature.

  Synthesized September 21, 2026

• State of the evidence: Psilocybin for PTSD ↓Opposes

  Reports that Australia's approval of MDMA and psilocybin for PTSD and depression was called premature by critics, with conditions requiring authorized psychiatrists, ethics approval per patient, and use with psychotherapy.

  Synthesized September 21, 2026