Australia’s medicines regulator is asking whether the country’s medicinal cannabis access rules still make sense, after a surge in prescriptions for products that have never been formally assessed for quality, safety or efficacy.
The Therapeutic Goods Administration (TGA) yesterday opened a two-month consultation on the regulation of unapproved medicinal cannabis products, focusing on whether the current access pathways are fit for purpose and what additional controls may be needed to protect patients.
The move comes amid growing concern from doctors, pharmacists and state health departments about the rapid expansion of the market, particularly for products containing high levels of tetrahydrocannabinol (THC).
How the system works now
Since 2016, patients have been able to access medicinal cannabis products legally via two “unapproved goods” pathways: the Special Access Scheme (SAS) and the Authorised Prescriber (AP) scheme.
These mechanisms were intended for exceptional clinical circumstances — such as accessing experimental or overseas-approved medicines when no suitable registered option was available. At the time, regulators expected limited use by a small number of prescribers for a narrow range of products and patients.
Instead, more than 99% of medicinal cannabis now prescribed in Australia is unapproved, with more than 1,000 products supplied. SAS approvals have risen from about 58,000 in 2020 to nearly 178,000 in 2024, with almost half involving Category 5 products, which typically have high THC content.
Because unapproved products are not on the Australian Register of Therapeutic Goods (ARTG), they have not undergone the TGA’s pre-market evaluation of quality, manufacturing standards, safety and clinical evidence. Sponsors of unapproved products also face fewer post-market obligations, such as mandatory adverse event reporting.
Why the review is happening
The TGA says it has received increasing reports of patients presenting with mental health problems — including psychosis and dependency — linked to medicinal cannabis use, particularly high-THC products.
Other cited risks include cardiovascular issues, respiratory harms from inhalation devices, inaccurate dosing, and use in vulnerable groups such as young people and pregnant women. The regulator also notes ongoing concerns about product quality, labelling and the limited evidence supporting some indications.
The consultation will focus on two core questions:
- Whether SAS and AP arrangements offer sufficient oversight for the supply of unapproved medicinal cannabis; and
- How to address safety risks, particularly those linked to THC-containing products.
Potential reforms could include tighter quality and labelling standards, THC limits, restrictions on certain dosage forms, or measures to encourage ARTG registration.
The TGA says it does not plan to remove access to medicinal cannabis but wants to ensure products are “of appropriate quality” and supported by evidence. If urgent safety issues are identified, it has pledged “prompt and appropriate regulatory actions”.
Pharmacists call for broader reform
The Pharmaceutical Society of Australia (PSA) has welcomed the TGA’s move but says the changes must go further to ensure medicinal cannabis is prescribed and dispensed safely.
“PSA commends the TGA for taking action to address the growing safety concerns of both healthcare professionals and our community,” PSA national president Associate Professor Fei Sim said.
“Unregistered medicinal cannabis products pose serious challenges, including inconsistent dosing, limited safety data, and minimal post-market surveillance. These gaps increase the risk of harm and demand greater care in prescribing.
“The SAS and AP scheme were designed for unique clinical situations, not as a loophole for hundreds of products to bypass regulatory scrutiny.”
While supporting medicinal cannabis use when clinically appropriate and overseen by qualified professionals, the PSA says the current system leaves prescribers and pharmacists without the tools they need for safe, informed patient care.
It is also calling on other regulators to increase scrutiny of aggressive telehealth and direct-to-consumer models, which fall outside the TGA’s review but have raised concerns about clinical governance.
“There is a place for medicinal cannabis products,” Sim said, “but we need to prioritise the tools and regulatory environment that promote their safe and appropriate use.”
Implications for biotech and health
For biotech and life sciences investors, the consultation is a signal that Australia’s fast-growing medicinal cannabis market — worth an estimated $250 million annually — could face new compliance hurdles. Any tightening of the SAS or AP pathways could shift commercial incentives towards full ARTG registration, potentially benefiting companies with the resources and data to meet the TGA’s robust safety and efficacy data requirements.
The outcome will also influence how clinicians prescribe, how products are developed and marketed, and how patients access treatment in a space where demand has far outstripped the original regulatory design.
Submissions can be made via the TGA’s consultation hub until 11:59 pm AEDT on October 7.