TGA approves prescription of psychedelic medicines

02 March 2023

From 1 July 2023, approved psychiatrists will be able to prescribe medicines containing psilocybin and MDMA, for treatment of depression and post-traumatic stress disorder, respectively.

The Therapeutic Goods Administration (TGA) announced its decision on 3 February 2023 to change the classification of these substances so they could be used for medical treatment.

Prescribing psychiatrists will need to be approved under the TGA’s Authorised Prescriber Scheme. They must also obtain human research ethics committee approval for the use of the substances for patients under their care.

In a media release, the TGA said the decision to approve psilocybin and MDMA to treat depression and PTSD acknowledged ‘the current lack of options for patients with treatment-resistant mental illnesses.’

‘It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients,’ the media release said.

Psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines when used to treat depression and PTSD under these specific conditions. For all other uses, they will remain in Schedule 9 (Prohibited Substances).

Read the TGA’s Frequently Asked Questions about the decision.