TGA Faces Scrutiny Over Lack of Safety Investigations Into Unapproved Medicinal Cannabis Products

Australia’s booming medicinal cannabis sector is facing new questions about oversight after the Therapeutic Goods Administration (TGA) revealed it has not conducted safety investigations into the majority of unapproved cannabis products, despite receiving hundreds of adverse event reports from patients.

A Regulatory Gap Exposed

Between July 2022 and June 2025, the TGA received 615 adverse event reports linked to unapproved medicinal cannabis products. Reported effects ranged from coughing and dizziness to more serious concerns such as psychosis, suicidal ideation, schizophrenia, and bipolar episodes.

Despite these red flags, the regulator admitted it had not launched formal investigations, stating that no “safety signals” strong enough to warrant a probe had been detected. Instead, the agency has relied on existing monitoring systems, which critics argue are insufficient given the rapid growth of Australia’s medicinal cannabis industry.

The revelations have sparked concern among health professionals, patient advocates, and policymakers who fear that Australia’s regulatory framework has not kept pace with the expansion of cannabis prescribing under the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways.

Why Oversight Matters Now

Unapproved medicinal cannabis products make up the vast majority of prescriptions in Australia. With over 1,000 different products available — many containing varying levels of THC and CBD — patients often consume medicines that have not undergone the same rigorous safety reviews as approved pharmaceuticals.

Doctors prescribing through SAS and AP schemes are technically operating within the law, but the products themselves lack comprehensive TGA approval. This leaves patients exposed to potential risks without the assurance of formal regulatory testing.

“This is a public health blind spot,” says Dr. Emily Richards, a clinical pharmacologist at the University of Sydney. “We’re seeing products prescribed to thousands of Australians without the safety and efficacy checks we apply to every other medicine. The absence of investigations despite serious reports is troubling.”

Industry and Market Implications

The Australian legal cannabis market is projected to grow from USD $123.9 million in 2024 to over $800 million by 2033, driven largely by medicinal use. Companies supplying unapproved cannabis medicines benefit from a regulatory grey zone that allows faster market entry but with fewer compliance burdens.

If the TGA decides to tighten oversight — for example, requiring higher quality testing, stricter labelling, or evidence-based trials — the industry could face major cost increases. Smaller players may be forced out, while larger pharmaceutical-backed cannabis firms could benefit from consolidation.

Investors are watching closely: a regulatory crackdown could limit product diversity in the short term but increase consumer trust and market stability in the long term.

Political and Legal Pressures

The issue lands at a sensitive time. Across several states, political parties are beginning to debate broader cannabis reforms. In Victoria, Liberal Party members recently pushed for a regulated retail cannabis market, arguing for a tightly controlled but taxable system similar to Canada’s.

However, the safety debate around medicinal products could complicate those discussions. If public trust in medicinal cannabis oversight erodes, it could weaken momentum for broader legalization.

Looking Ahead: A Review in Motion

In response to mounting concerns, the TGA announced it will launch a review of unapproved medicinal cannabis safety and regulatory frameworks, with particular focus on high-THC products. This consultation process is expected to explore:

• Whether stricter reporting requirements should be mandated for prescribers
• If unapproved products should face mandatory safety investigations after certain thresholds of adverse events
• Whether Australia should transition towards requiring more cannabis medicines to undergo full TGA approval

Consumer groups are calling for transparency in the review, with patient safety advocates demanding a public database of adverse events linked to cannabis products.