Therapeutic Goods Administration will launch soon a consultation to address the growing concern about unapproved medical cannabis products in Australia.
Increased concern over the safety of unapproved medical cannabis products, particularly those with high concentrations of the cannabinoid THC (THC), which is intoxicating, has triggered the Administration’s consultation to begin on 11 August, 2025.
TGA is Australia’s regulator for therapeutic goods. It says there are more than 1,000 products that are not approved and can be legally accessed in Australia through Special Access Schemes and Authorised Prescriber schemes.
The original intention of these schemes was to allow access to products that are often used as experimental treatments in clinical trials. They can also be applied to exceptional situations at the prescriber’s discretion. says the TGA.
TGA will consult on the appropriateness of regulatory oversight and safety concerns for such products. A key concern is that a growing number of digital and telehealth services prescribe unapproved cannabis medicinal products. This issue will not be addressed in this consultation, as it falls outside of the Administration’s remit.
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.”
The Australian Health Practitioner Regulation Agency, which released the updated guidelines before the comments of the Minister, had been prompted by a spike in medical cannabis prescriptions. One example was given of a few doctors who issued more than 10 000 prescriptions over a period of six months.
Australian Medical Association (AMA), which supports the guidelines, also expresses concern that some companies exploit special access schemes in order to avoid scrutiny and the hurdles associated with listing products at the Australian Register of Therapeutic Goods.
This consultation by the TGA is seen as an important first step in regulating reform.
The Administration says that “this is an important regulatory reform issue, and it may require further consultations to examine detailed and specific options for regulatory changes.”