Australia's TGA Targets Closed-Loop Prescribing in Medical Cannabis Reform Push

Australia's Therapeutic Goods Administration has committed to reforming the regulatory framework for unapproved medicinal cannabis products, with a focus on closed-loop supply chains where clinics prescribe, dispense, and supply cannabis. The move follows a formal consultation that drew 786 submissions and comes as SAS-B prescribing volumes continue to climb, with at least 148,388 decisions recorded in the first eight months of 2026.

Australia's Therapeutic Goods Administration (TGA) has signaled its clearest intent yet to reform the special access scheme (SAS) framework underpinning the country's medical cannabis market, now the largest outside North America. In its Business Plan for 2026-27, the regulator committed to examining options for reforming the regulatory framework governing unapproved medicinal cannabis products, with a specific focus on closed-loop supply chains, compounding, and point-of-care manufacturing and distribution.

The pathway under review processed at least 148,388 SAS-B decisions in the first eight months of 2026 alone, already running ahead of a 2025 total that outstripped everything the TGA reported for the whole of 2024. A mechanism originally built for exceptional, case-by-case access has become, by volume, a mainstream prescribing channel for pain, anxiety, and sleep disorders.

Although cannabis is not named directly in the business plan, vertically integrated operators who prescribe, dispense, and supply fall squarely within the closed-loop definition. Steve Jones, writing for Medical Republic, documented concerns about these ecosystems as early as 2024, including clinics charging fees to release prescriptions and commercial arrangements that channel patients to preferred pharmacies.

The reform commitment formalizes a review that has been in the works for some time. In September 2024, the Australian Health Practitioner Regulation Agency (AHPRA) established a Rapid Regulatory Response Unit to investigate online prescriptions for medical cannabis. Prescribing data later uncovered what the regulator called concerning patterns, raising red flags and showing that some practitioners were not meeting their professional obligations.

The TGA opened formal consultation on August 11, 2025, citing increasing public and professional concern driven primarily by negative mainstream media coverage. The consultation closed on October 7, 2025, after receiving 786 submissions, but the TGA has since offered no meaningful indication of the changes it plans to make, saying only that it was committed to helping practitioners and consumers better understand the risks and exploring collaborative clinical education opportunities.

The business plan also sets a target of 65 percent for finalizing alleged non-compliance reports relating to advertising or therapeutic goods outside approval pathways. The TGA frames this as a caseload-clearance target rather than a claim about the scale of non-compliance, alongside a strategic commitment to strengthen proactive compliance and disruption capabilities focused on high-risk products, entities, and digital supply pathways.

Business of Cannabis has previously reported that clinics failing to comply with TGA advertising rules drew more than 165 infringement notices worth over A$2.3 million across two years, including A$118,800 against Dispensed Pty Ltd and A$99,000 against ACPharm Queensland.

The reform timeline may be paced alongside the sunsetting of the Narcotic Drugs Regulation 2016 and the Narcotic Drugs (Licence Charges) Regulation 2016, which license cannabis cultivation and manufacture in Australia. Both instruments sunset automatically on April 1, 2027, unless remade, and the Department of Health closed its consultation on remaking them on July 19, 2026, with no completion date announced.