Australia’s ongoing efforts to restrict its medical cannabis market, now the largest outside North America, are now taking aim at the special access scheme (SAS) framework on which the country’s hundreds of thousands of annual prescriptions are based.
In its Business Plan for 2026-27, published this week, the Therapeutic Goods Administration (TGA) has committed to examine options for reforming the regulatory framework governing unapproved medicinal cannabis products.
The pathway it wants to reform processed at least 148,388 SAS-B decisions in the first eight months of 2026 alone, already running ahead of a 2025 total that itself outstripped everything the TGA reported for the whole of 2024.
A mechanism built for exceptional, case-by-case access has become, by volume, a mainstream prescribing channel for pain, anxiety and sleep disorders. The TGA’s 2026-27 business plan is the clearest signal yet that it intends to stop treating it as an exception.
The commitment formalises a review of the rampantly expanding medical cannabis market that has been in the works for some time.
Two years ago (September 2024), the Australian Health Practitioner Regulation Agency (AHPRA) established a new Rapid Regulatory Response Unit (RRRU), tasked with investigating rapidly evolving healthcare models, including online prescriptions for medical cannabis.
Just under a year later, prescribing data gathered by the regulator uncovered what it called concerning prescribing patterns, raising ‘red flags’ and showing that ‘some practitioners are not meeting their professional obligations’.
Prompted, in its own words, by ‘increasing public and professional concern’, driven primarily by negative mainstream media coverage, the TGA announced plans to launch a formal review of the unapproved medicinal cannabis framework, opening formal consultation on August 11.
Since its public consultation, which received 786 submissions, closed on October 07, 2025, the TGA has offered no meaningful indication of the changes it plans to make to Australia’s prescribing framework. In its response to the hundreds of submissions, it simply said it was committed to helping practitioners and consumers ‘better understand the risks’ and to ‘exploring collaborative clinical education opportunities’ with other regulators.
While still vague, the TGA’s business plan offers perhaps the most publicly available insights into the planned changes to date.
Under its first strategic objective, the TGA states it will ‘advance appropriate regulatory frameworks for therapeutic goods that are not entered in the ARTG (Australian Register of Therapeutic Goods), including closed-loop supply chains, compounding, and point-of-care manufacturing and distribution.’
Although cannabis is not named directly, vertically integrated operators who prescribe, dispense, and supply fall squarely within this ‘closed-loop’ definition.
Steve Jones, writing for Medical Republic, suggested these closed-loop ecosystems were already raising concerns among the medical community back in 2024, documenting a pattern of clinics charging fees to release prescriptions and commercial arrangements that channel patients to preferred pharmacies.
Alongside this, it has set a target of 65% for the ‘percentage of alleged non-compliance reports relating to advertising or therapeutic goods outside of approval pathways or exemptions that have been finalised.’
The TGA is explicit that this is a caseload-clearance target, not a claim about the scale of non-compliance, and it sits alongside a strategic commitment to ‘strengthen proactive compliance and disruption capabilities, focusing 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$2.3m across two years, including A$118,800 against Dispensed Pty Ltd and A$99,000 against ACPharm Queensland, in an examination of clinics scaling responsibly. The TGA frames the compliance push as one part of a broader digital transformation.
TGA dashboard data extracted on September 3, 2026, puts SAS-B decisions for the year to date at a minimum of 148,388.
That floor comes from the roughly one in five records the TGA discloses in full; the remaining four in five are redacted below ten applications for privacy, which could push the real total as high as 193,000.
A full-year 2025 export shows disclosed decisions total 207,980, already ahead of the 177,762 the TGA reported for the whole of 2024, with genuine 2025 volume likely higher still once its 5,713 redacted rows are accounted for. On a monthly pace basis, 2026 is running roughly 7% ahead of 2025.
Category 5 products, those with less than 2% CBD and correspondingly THC-dominant, held at around half of disclosed applications in both years, a pattern matching the near-half share the TGA itself flagged as a safety concern in its consultation paper.
Disclosed TGA decisions vs. the estimated true total once privacy-redacted rows are included
0 100k 175k 250k 177,762 2024 full year (TGA-reported) ≈236,500 est. ≥207,980 2025 full year ≈173,000 est. ≥148,388 2026* Jan–Aug only
Disclosed in full by the TGA Estimated additional (rows redacted below 10)
*2026 covers January–August only; on a monthly basis it is running ≈7% ahead of 2025. Source: TGA SAS-B dashboard bulk data, extracted September 3, 2026; 2024 figure per TGA consultation paper, August 2025.
Oral liquid’s share fell from second place in 2025 (62,479 disclosed applications) to third in 2026 (29,140), overtaken by pastilles, which climbed from 43,397 to 47,164 and now trail only dried herb.
Alongside the changes expected directly from the TGA, the Narcotic Drugs Regulation 2016 and the Narcotic Drugs (Licence Charges) Regulation 2016, the two instruments that license cannabis cultivation and manufacture in Australia alongside the country’s older opium poppy industry, sunset automatically on April 1, 2027, unless remade.
The Department of Health closed its consultation on remaking them on July 19, 2026, with submissions folded into what it calls ‘the sunsetting and remaking process’ with no completion date announced.
Any cannabis-specific licensing change the TGA and ODC want to make has to be threaded through that same shared deadline. As for indications of a potential timeline for reform enforcement, it’s likely that they are being paced to sit alongside this process.
The post Australia’s Medical Cannabis Reforms to Target ‘Closed Loop’ Prescribing appeared first on Business of Cannabis.
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In its Business Plan for 2026-27, published this week, the Therapeutic Goods Administration (TGA) has committed to examine options for reforming the regulatory framework governing unapproved medicinal cannabis products.
The pathway it wants to reform processed at least 148,388 SAS-B decisions in the first eight months of 2026 alone, already running ahead of a 2025 total that itself outstripped everything the TGA reported for the whole of 2024.
A mechanism built for exceptional, case-by-case access has become, by volume, a mainstream prescribing channel for pain, anxiety and sleep disorders. The TGA’s 2026-27 business plan is the clearest signal yet that it intends to stop treating it as an exception.
What do the proposed changes actually mean for Australia’s medical cannabis industry?
The commitment formalises a review of the rampantly expanding medical cannabis market that has been in the works for some time.
Two years ago (September 2024), the Australian Health Practitioner Regulation Agency (AHPRA) established a new Rapid Regulatory Response Unit (RRRU), tasked with investigating rapidly evolving healthcare models, including online prescriptions for medical cannabis.
Just under a year later, prescribing data gathered by the regulator uncovered what it called concerning prescribing patterns, raising ‘red flags’ and showing that ‘some practitioners are not meeting their professional obligations’.
Prompted, in its own words, by ‘increasing public and professional concern’, driven primarily by negative mainstream media coverage, the TGA announced plans to launch a formal review of the unapproved medicinal cannabis framework, opening formal consultation on August 11.
Since its public consultation, which received 786 submissions, closed on October 07, 2025, the TGA has offered no meaningful indication of the changes it plans to make to Australia’s prescribing framework. In its response to the hundreds of submissions, it simply said it was committed to helping practitioners and consumers ‘better understand the risks’ and to ‘exploring collaborative clinical education opportunities’ with other regulators.
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What does the TGA’s business plan suggest about changes to medical cannabis?
While still vague, the TGA’s business plan offers perhaps the most publicly available insights into the planned changes to date.
Under its first strategic objective, the TGA states it will ‘advance appropriate regulatory frameworks for therapeutic goods that are not entered in the ARTG (Australian Register of Therapeutic Goods), including closed-loop supply chains, compounding, and point-of-care manufacturing and distribution.’
Although cannabis is not named directly, vertically integrated operators who prescribe, dispense, and supply fall squarely within this ‘closed-loop’ definition.
Steve Jones, writing for Medical Republic, suggested these closed-loop ecosystems were already raising concerns among the medical community back in 2024, documenting a pattern of clinics charging fees to release prescriptions and commercial arrangements that channel patients to preferred pharmacies.
Alongside this, it has set a target of 65% for the ‘percentage of alleged non-compliance reports relating to advertising or therapeutic goods outside of approval pathways or exemptions that have been finalised.’
The TGA is explicit that this is a caseload-clearance target, not a claim about the scale of non-compliance, and it sits alongside a strategic commitment to ‘strengthen proactive compliance and disruption capabilities, focusing 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$2.3m across two years, including A$118,800 against Dispensed Pty Ltd and A$99,000 against ACPharm Queensland, in an examination of clinics scaling responsibly. The TGA frames the compliance push as one part of a broader digital transformation.
How large is Australia’s medical cannabis market in 2026?
TGA dashboard data extracted on September 3, 2026, puts SAS-B decisions for the year to date at a minimum of 148,388.
That floor comes from the roughly one in five records the TGA discloses in full; the remaining four in five are redacted below ten applications for privacy, which could push the real total as high as 193,000.
A full-year 2025 export shows disclosed decisions total 207,980, already ahead of the 177,762 the TGA reported for the whole of 2024, with genuine 2025 volume likely higher still once its 5,713 redacted rows are accounted for. On a monthly pace basis, 2026 is running roughly 7% ahead of 2025.
Category 5 products, those with less than 2% CBD and correspondingly THC-dominant, held at around half of disclosed applications in both years, a pattern matching the near-half share the TGA itself flagged as a safety concern in its consultation paper.
SAS-B decisions have outpaced 2024 in eight months
Disclosed TGA decisions vs. the estimated true total once privacy-redacted rows are included
0 100k 175k 250k 177,762 2024 full year (TGA-reported) ≈236,500 est. ≥207,980 2025 full year ≈173,000 est. ≥148,388 2026* Jan–Aug only
Disclosed in full by the TGA Estimated additional (rows redacted below 10)
*2026 covers January–August only; on a monthly basis it is running ≈7% ahead of 2025. Source: TGA SAS-B dashboard bulk data, extracted September 3, 2026; 2024 figure per TGA consultation paper, August 2025.
Oral liquid’s share fell from second place in 2025 (62,479 disclosed applications) to third in 2026 (29,140), overtaken by pastilles, which climbed from 43,397 to 47,164 and now trail only dried herb.
Alongside the changes expected directly from the TGA, the Narcotic Drugs Regulation 2016 and the Narcotic Drugs (Licence Charges) Regulation 2016, the two instruments that license cannabis cultivation and manufacture in Australia alongside the country’s older opium poppy industry, sunset automatically on April 1, 2027, unless remade.
The Department of Health closed its consultation on remaking them on July 19, 2026, with submissions folded into what it calls ‘the sunsetting and remaking process’ with no completion date announced.
Any cannabis-specific licensing change the TGA and ODC want to make has to be threaded through that same shared deadline. As for indications of a potential timeline for reform enforcement, it’s likely that they are being paced to sit alongside this process.
The post Australia’s Medical Cannabis Reforms to Target ‘Closed Loop’ Prescribing appeared first on Business of Cannabis.
Continue reading...
