Australia's TGA Signals Review of 'Special Access' Cannabis Prescribing Pathway

The regulator's 2026-27 business plan targets the unapproved-product route now used for hundreds of thousands of cannabis prescriptions annually, as a separate cultivation-licensing review also opens.

FILE — statehouse · B.D. Gilfry / CC BY-SA 2.0

Australia's Therapeutic Goods Administration (TGA) has committed to examining reforms to the regulatory pathway that underpins the bulk of the country's medicinal cannabis prescriptions, according to Business of Cannabis, which reviewed the TGA's newly published Business Plan for 2026-27.

The pathway in question is the Special Access Scheme (SAS), designed for case-by-case access to unapproved medicines but now, by volume, functioning as a mainstream prescribing channel for conditions including pain, anxiety and sleep disorders, Business of Cannabis reported.

The Numbers Behind the Review

According to Business of Cannabis, the TGA processed at least 148,388 SAS-B decisions in just the first eight months of 2026 — already on pace to exceed the 2025 total, which itself surpassed everything recorded for all of 2024. The outlet described Australia's medicinal cannabis market as the largest outside North America.

How the Scrutiny Built Up

The review did not emerge in isolation. Business of Cannabis traced its roots to September 2024, when the Australian Health Practitioner Regulation Agency (AHPRA) set up a Rapid Regulatory Response Unit to examine fast-evolving prescribing models, including online cannabis prescriptions. Data gathered by the unit later surfaced what AHPRA called 'concerning prescribing patterns,' raising 'red flags' and finding that 'some practitioners are not meeting their professional obligations,' per the outlet's reporting.

The TGA subsequently opened a formal public consultation on August 11, which closed on October 7, 2025, after drawing 786 submissions, Business of Cannabis reported. In its response to that consultation, the TGA said only that it was committed to helping practitioners and consumers 'better understand the risks' and to 'exploring collaborative clinical education opportunities' with other regulators — language the outlet characterized as vague. The source material reviewed for this story was cut off before detailing exactly what the business plan's reference to 'closed loop' prescribing reforms would entail, so the specific mechanics of any proposed change remain unclear from available reporting.

A Separate Track: Cultivation Licensing

Parallel to the prescribing review, Australia's Department of Health, Disability and Ageing has opened its own consultation on the rules governing medicinal cannabis cultivation licenses, according to MMJDaily. The Narcotic Drugs Regulation 2016 and the Narcotic Drugs (Licence Charges) Regulation 2016 are due to sunset on April 1, 2027, MMJDaily reported, with submissions invited from June 22 to July 19, 2026, through the Department's Consultation Hub. MMJDaily noted the Department has signaled a 'light touch' remake, limited to necessary drafting edits.

Market Backdrop

The prescribing review comes as Australia's medical cannabis sector has continued to draw corporate activity, according to our database of related coverage. Aurora Cannabis said in March 2026 it was pivoting to a medical-only strategy targeting growth in Australia, while Tilray Medical announced an expanded Australian portfolio the same month. Avicanna's subsidiary SMGH completed its first commercial export to Australia in March 2026, and K&L Gates advised on a merger between Cannatrek and Little Green Pharma in June 2026. Separately, Australia introduced a world-first THC driving limit for medicinal cannabis users in June 2026, according to Yahoo — a move that, alongside the SAS and cultivation reviews, suggests regulators are tightening multiple parts of the framework simultaneously.

What to Watch

With the TGA yet to specify concrete rule changes and its own consultation response described by Business of Cannabis as offering little detail, it remains uncertain how far any 'closed loop' restrictions on SAS-B prescribing would go, or when they might take effect. The cultivation-rule sunset deadline of April 2027 gives that separate process a firmer timeline. Together, the two reviews suggest Australian regulators are reassessing both ends of the medicinal cannabis supply chain — cultivation and prescribing — though the practical impact on clinics, prescribers and licensed producers will depend on decisions neither agency has yet made public in detail.