In August 2025, the Therapeutic Goods Administration (TGA) released a consultation paper reviewing the safety and regulatory oversight of unapproved medicinal cannabis products in Australia.
The consultation focuses on patient safety, product quality, and existing access pathways. It reflects growing regulatory attention as medicinal cannabis prescribing continues to expand nationwide.
At Cannabis Warehouse Australia, we monitor these developments closely to help pharmacies and practitioners stay informed.
Why the TGA Is Reviewing Medicinal Cannabis Oversight
Medicinal cannabis access in Australia has grown far beyond what was originally anticipated when the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways were introduced. According to the TGA, more than 99% of medicinal cannabis products currently supplied are unapproved, meaning they have not undergone pre-market evaluation for safety, quality, or efficacy .
The TGA has identified that these unapproved pathways—designed for exceptional and limited use—are now being used at scale, reducing incentives for sponsors to register products on the Australian Register of Therapeutic Goods (ARTG) .
Key Safety Concerns Raised
The consultation highlights several emerging risks associated with unapproved medicinal cannabis products, particularly those containing high concentrations of THC. The TGA notes increasing reports of adverse events, including mental health impacts such as anxiety, psychosis, and dependency, as well as cardiovascular and neurological risks .
Between 2016 and July 2025, over 1,100 adverse event reports linked to medicinal cannabis were recorded in the TGA’s internal system, with nearly one quarter classified as serious cases .
Dosage Forms Under Scrutiny
The consultation also raises concerns about the wide range of dosage forms being prescribed under the SAS and AP schemes. As of July 2025, oral liquids, oils, and dried herb were the most commonly accessed forms, while other formats—including edibles—have limited clinical evidence supporting their safety and efficacy .
The TGA specifically notes that unapproved devices used for inhalation or vaping are not subject to the same safety requirements as approved medical devices, raising risks related to burns, device malfunction, and chemical exposure .
Vulnerable Patient Groups
Special consideration is being given to paediatric patients, pregnant or breastfeeding women, and individuals with mental health or cardiovascular conditions. The TGA highlights limited evidence supporting THC use in these populations and signals that stronger restrictions or safeguards may be required .
What Regulatory Changes Are Being Considered?
While the TGA has stated it does not intend to remove access to medicinal cannabis, it is actively seeking feedback on reforms that could include:
-
- Greater regulatory responsibility placed on product sponsors rather than prescribers
-
- Stronger quality, labelling, and safety requirements
-
- Increased transparency about whether a product has been evaluated by the TGA
-
- Incentives or transitional pathways for sponsors to move products onto the ARTG
-
- Potential restrictions on high-risk dosage forms or THC concentrations
These changes aim to balance patient access with stronger assurance of product safety and quality .
What This Means for Industry Stakeholders
For pharmacies, sponsors, and healthcare providers, this consultation is a clear signal that regulatory expectations are evolving. Businesses operating in the medicinal cannabis supply chain should prepare for increased scrutiny around product quality, documentation, labelling, and reporting obligations.
At Cannabis Warehouse Australia, we support compliant, transparent, and future-ready supply chain operations. As regulatory frameworks mature, robust warehousing, documentation, and quality controls will become even more critical.
