Australia approves psychedelics as medicines

Last week, the Australian equivalent of the FDA, the Therapeutic Goods Administration, approved the use of psychedelic substances in magic mushrooms and MDMA (commonly known as ecstasy) by people with certain mental health conditions.

As of July, MDMA and psilocybin, the active ingredient in magic mushrooms, will be considered drugs in Australia – meaning they’re approved for controlled use when prescribed by a psychiatrist, to treat post-traumatic stress disorder and treatment-resistant depression.

The regulatory requirements surrounding use are expected to be robust. Prescribing psychiatrists will require approval from an ethics committee as well as approval under the TGA’s authorised prescriber scheme, and will need to demonstrate appropriate training, vigorous patient selection, treatment protocols, patient monitoring, governance and reporting criteria.

This is great news for patients in Australia with treatment-resistant mental illnesses who have few other options, and might be a precursor to wider adoption, including in Israel. It will be interesting to see whether additional countries, including Israel, will follow suit and approve psychedelics as medicines, and if so, under what conditions.