The Therapeutic Goods Administration (TGA) will soon launch a public consultation on growing concerns surrounding the myriad unapproved medicinal cannabis products available in Australia.
The trigger for the Administration’s consultation, to kick off on 11 August 2025, is increasing concern about the safety risks associated with unapproved medicinal cannabis products; particularly those with high levels of the intoxicating cannabinoid tetrahydrocannabinol (THC).
The TGA, Australia’s regulatory authority for therapeutic goods, says more than 1,000 unapproved products are being supplied in Australia and are being accessed legally through the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme.
“These schemes were initially designed to provide access to experimental products often used in clinical trials, or for exceptional circumstances at the discretion of the prescribing practitioner,” says the TGA.
The TGA will be consulting on whether there is appropriate regulatory oversight of such products and their safety risks. Another key issue is the growing number of telehealth and digital services prescribing specific unapproved medicinal cannabis products or classes of products, but this won’t be covered in the consultation as it is outside the remit of the Administration.
The TGA’s announcement follows Australia’s Federal Health Minister Mark Butler stating last week that he had asked regulators to look into and make recommendations concerning various issues relating to medical cannabis — including some business practices he said were “frankly, unsafe and certainly unscrupulous.”
Prior to the Minister’s comments, the Australian Health Practitioner Regulation Agency (Ahpra) released updated prescribing guidelines after a jump in what the Agency said were poor medical cannabis prescribing practices. An example given was a handful of practitioners who had issued more than 10,000 scripts within a 6-month period.
The Australian Medical Association (AMA) came out in support of the updated guidelines and also expressed concerns companies were exploiting special access schemes to avoid the scrutiny and hurdles involved with listing products on the Australian Register of Therapeutic Goods (ARTG).
The upcoming TGA consultation is regarded as a first step towards regulatory reform.
“This is a significant regulatory reform consideration, and further consultations may be required to explore detailed and specific regulatory change options,” says the Administration.
