The Therapeutic Goods Administration (TGA) has released its response to the feedback it received to its consultation on the safety and regulatory oversight of unapproved medicinal cannabis products. The TGA’s response suggests there is a perception among some stakeholders that the current access model, anchored in the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme, may require updating to reflect the sector’s significant growth and the evolving understanding of medicinal cannabis products, particularly those containing delta-9-tetrahydrocannabinol (THC).
This article sets out the background to the TGA’s review, the key themes emerging from the TGA’s response, and what the TGA’s next steps may be, including what these could mean for prescribers, sponsors, and patients.
Background
The majority of medicinal cannabis products prescribed to patients in Australia are ‘unapproved’, meaning they have not undergone pre-market evaluation by the TGA.[1] Access to these products is facilitated through the SAS and AP Schemes, pathways that have enabled the sector to grow and meet patient demand.[2] For more about the AP Scheme and how it works, please see our previous insight in the context of psychedelic substances.
There has been a rapid increase in the number of medicinal cannabis products that are available, with more than 1,000 products now being supplied in Australia, and SAS B approvals rising from 57,711 in 2020 to 177,762 in 2024.[3] This growth has been supported by innovative business models, including vertically integrated, direct‑to‑consumer telehealth prescribing companies that have improved patient access, as discussed in our IP Whiteboard post here.
In August 2025, the TGA opened a consultation to assess whether existing oversight remains appropriate and to gather safety data.[4] Seven hundred and ninety submissions were provided from across the sector, including clinicians, colleges, pharmacists, patient groups, industry, and government stakeholders. The TGA’s response was published on 20 February 2026.
What stakeholders said
The TGA’s response summarised the submissions they received this way:
‘There was agreement across stakeholder groups that the current access framework, used 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. While reform was generally supported, there was a strong desire to carefully consider any impact to patient access.’
The TGA’s response provides an indication about the issues that they gave the most careful consideration:
- (Awareness and transparency) the importance of patient awareness of the regulatory status of medicinal cannabis products.
- (High-THC products) high-THC formulations and their appropriate use, including the importance of patient selection and dosing guidance.
- (Dosage forms) dosage forms and packaging, including in particular dried herb and concentrated extracts for inhalation and pastilles and gummies.
- (Quality standards) the importance of consistent product quality standards and enforcement across domestic and imported medicinal cannabis products, as well as the establishment of appropriate device quality standards.
- (Labelling) labelling and packaging requirements, including trade name restrictions, plain packaging, standardisation of Cannabidiol (CBD) and THC expression, warning statements, transparency of registration status, Product Information documents, and child-resistant closures.
- (Efficacy data) the importance of high quality safety and efficacy data for medicinal cannabis products.
- (Vulnerable populations) THC prescribing considerations for certain patient groups.
The TGA has also indicated that it will prioritise improving the information that is available to health care practitioners and patients and exploring opportunities for collaborative clinical education with other health regulators.
Key takeaways and what comes next?
Drawing from this consultation process, the TGA has confirmed that its next steps will be to prioritise awareness and education aimed at supporting ‘health care practitioners and consumers to better understand the risks associated with unapproved medicinal cannabis products.’ The TGA also indicated an intention ‘to explore collaborative clinical education opportunities with other health regulators’ to support prescribers navigate their responsibilities under the SAS and AP Schemes.
We expect that the TGA will continue focus on development of the medicinal cannabis regulatory framework as it continues to mature. This will likely include:
- (Prescribers) an emphasis on education, documentation and patient communication about product status and risks, particularly for THC-containing products and inhaled dosage form products.
- (Sponsors) improved product quality and device standards that incorporate packaging and labelling requirements, including plain packaging, standardised THC and CBD expression, mandatory warnings, transparent registration status, Product Information documents, and child‑resistant closures for both domestic and imported products.
- (Patients) requirements for clearer communication about the approval status of products, consistent labelling and warnings, and potential restrictions on access to THC products for certain patient groups.
Sophisticated stakeholders who prepare early will be well placed for growth during this period of transition as reforms begin to crystallise.
Feature image by Joe from Pixabay.
[1] TGA, ‘Consultation: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products’, August 2025.
[2] Ibid.
[3] Ibid.
[4] Ibid.
