Medicinal Cannabis
The TGA has published its response to a major review of unapproved medicinal cannabis products, signalling a likely overhaul of how the medicine is accessed in Australia. The response, released on 20 February 2026, follows a consultation that drew 790 submissions and the regulator own view that the current access pathway is no longer fit for purpose. For prescribers, pharmacists and the claims sector, change is coming.
Why the TGA reviewed medicinal cannabis access
Almost a decade after medicinal cannabis became available in Australia, the vast majority of products reach patients through unapproved-product pathways rather than the Australian Register of Therapeutic Goods (ARTG). Industry data illustrates the scale: more than 1,000 medicinal cannabis products are supplied in Australia, and Special Access Scheme category B approvals rose from 57,711 in 2020 to 177,762 in 2024. The TGA opened its consultation in August 2025 to assess whether existing oversight remained appropriate and to gather safety data.
What the review found and proposed
The TGA received 790 submissions from clinicians, colleges, pharmacists, patient groups, industry and government, and published its response on 20 February 2026. A likely direction is to move away from the Special Access Scheme and Authorised Prescriber pathways for medicinal cannabis and toward requiring suppliers to register products on the ARTG, so that products supplied meet established standards for quality, safety and performance. The stated aim is not to restrict access for its own sake, but to lift the evidence and quality bar for products in use.
The prescribing conduct backdrop
The review sits against heightened concern about prescribing conduct. The Australian Health Practitioner Regulation Agency revealed that a small number of practitioners were each associated with very high volumes of cannabis prescriptions over short periods, and released updated guidance for prescribers and dispensers during 2025. Together, the regulatory signals point to a sector moving from rapid, lightly regulated growth toward tighter oversight.
What this means for the personal injury sector
Medicinal cannabis appears in workers compensation and CTP claims, particularly for chronic pain. Tighter regulation will sharpen questions about whether a cannabis prescription is appropriate, evidence-based and properly supported. Claims teams should expect the regulatory environment around these prescriptions to keep shifting, and should treat independent clinical review as an important check on cannabis-related treatment within claims.
Key Takeaways
- The TGA published its medicinal cannabis review response on 20 February 2026.
- The consultation drew 790 submissions across the sector.
- A likely direction is to move products toward ARTG registration and away from unapproved-product pathways.
- Heightened concern about prescribing conduct forms the backdrop to the review.
Frequently Asked Questions
What did the TGA medicinal cannabis review response cover?
Released on 20 February 2026, it responded to a consultation on the safety and regulatory oversight of unapproved medicinal cannabis products.
Will medicinal cannabis become harder to access?
The TGA has said its aim is to improve product quality and evidence rather than restrict access for its own sake, though access pathways are likely to change.
How are most medicinal cannabis products currently supplied?
The large majority are supplied as unapproved products through the Special Access Scheme or Authorised Prescriber pathways rather than via the ARTG.
Primary source: TGA review of unapproved medicinal cannabis products, response February 2026.
