What is TGA?

Australia's TGA rescheduling application for psilocybin and MDMA received over 13,000 public submissions with 98% in support, the largest ever for any medicine rescheduling in Australia.

“Over 13,000 Australians supported this submission through public submissions to our therapeutic goods administration supporting the medicine and over 98% of people supported the rescheduling of these medicines. And this was the largest amount of public submissions ever received by our regulators for rescheduling any medicines.”

Australia's authorized prescriber count for MDMA and/or psilocybin grew from 1 to 2 in early 2024 to 120 by mid-late 2026.

“We just found out that now there's 120 authorized prescribing psychiatrists in Australia for either MDMA or psilocybin or both medicines. So, that is a huge jump. You know, we started with one or two psychiatrists back at the start of 2024. We're now at the middle latter part of 2026.”

Tania de Jong on the risk-of-inaction argument that helped unlock Australian psychedelic regulation.

“One of the arguments that was really important for the Therapeutic Goods Administration was there's a risk to not doing anything.”

Why Australia's regulatory success required foregrounding the risk of inaction: framing the danger of doing nothing, not just the risk of the medicines, gave regulators a defensible reason to act.

“One of the arguments that was really important for the Therapeutic Goods Administration was there's a risk to not doing anything.”

Alltrna is the most advanced suppressor-tRNA company, currently in Phase I in healthy volunteers in Australia with a basket trial targeting liver inborn errors of metabolism on the horizon.

“Actually, Alltrna is the most advanced in this space. They're in the clinic with its lead suppressor tRNA in healthy volunteers in Australia. But they have an eye towards a Phase II basket trial.”

As of mid-late 2026, Australia has over 20 clinics and roughly 400 patients treated with psilocybin- and MDMA-assisted therapy, with no serious adverse events reported to the TGA.

“There's now over 20 clinics around Australia, mostly led by clinicians that we have trained through our certificate in psychedelic assisted therapies and over 400 patients or so roughly have been treated.”