The TGA has rejected a bid to down-schedule psychedelic substances psilocybin and MDMA (ecstasy), which would have allowed patients with psychiatric disorders greater access to the drugs.

Charity and lobby group Mind Medicine Australia made the application in July 2020, requesting the substances be classed as controlled drugs (S8) for clinical use by psychiatrists and addiction specialists rather than prohibited substances (S9). 

But in its final decision, released last month, the TGA concluded that the therapeutic value of the drugs was not established despite “promising” clinical trial findings.

The medicines regulator also said there would be increased risk of the substances being misused or diverted for illicit use across the supply chain if down-scheduled.