THE Therapeutic Goods Administration (TGA) has provided an overview of responses to its recent medicinal cannabis safety and regulation review (PD 11 Aug 2025), with concerns over lack of awareness surrounding its regulatory status paramount.
With more than 1,000 unapproved products being accessed through the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme, the review was prompted by increasing concern about the safety risks, particularly for products containing higher levels of tetrahydrocannabinol (THC).
There were 790 submissions to the consultation, with broad agreement that the current access framework, which is intended for exceptional clinical circumstances, "is not fit-for-purpose and not proportionate to the potential safety and quality risks associated with unapproved medicinal cannabis products".
Key concerns included limited consumer/patient awareness that the products are not regulated by the TGA and have not been evaluated for safety, quality and efficacy, with submissions arguing for listing on the Australian Register of Therapeutic Goods (ARTG).
Safety concerns around high THC products were raised, as well as health risks involved with smoking or vaping products, and pastille forms posing a risk to children.
Stakeholders highlighted risks inherent in vertically integrated telehealth services prescribing high volumes of medicinal cannabis with limited clinical oversight and called for prescriber eligibility standards, such as specialist training requirements or restrictions on initial telehealth prescribing.
There were also calls for greater enforcement of quality standards for medicinal cannabis products and devices.
In light of the responses, the TGA noted it is "undertaking actions to support healthcare practitioners and consumers to better understand the risks associated with unapproved medicinal cannabis products".
"In doing this, we will also aim to explore collaborative clinical education opportunities with other health regulators, reminding prescribers of their responsibilities and conditions of their approvals when prescribing unapproved medicinal cannabis products."
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