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TGA reveals compliance priorities
Cannabis, vapes, weight-loss drugs, and melatonin are among the TGA’s 2026–27 priority areas, as it announces a new compliance and enforcement agenda.
The TGA’s priority focus areas will be reviewed quarterly and updated as required, it says.
Goods Administration (TGA) has vowed to take firm action ‘when the rules are broken’, as it reveals its compliance priorities for the next two years.
On Friday, the TGA Compliance Principles 2026 and 2027 were released, detailing the body’s approach to monitoring and enforcing regulatory compliance for therapeutic goods.
It says the principles allow a quick response to high-impact issues, such as misinformation, digital platforms and online purchases.
In 2026–27, the TGA will focus on safeguarding therapeutic goods, ‘educating to empower’, protecting those most at risk, leveraging digital capability, and strengthening enforcement.
Specifically, its compliance and enforcement activities will focus on the below therapeutic goods – a list that will be reviewed after three months:
- Direct to consumer in vitro diagnostic kits
- Erectile dysfunction medications
- Foetal dopplers
- Listed medicine advertising
- Medicinal cannabis
- Melatonin
- Software as a medical device
- Substandard and falsified therapeutic goods
- Sunscreen
- Weight-loss medications
- Therapeutic goods used in cosmetic procedures
- Vaping goods
TGA boss Professor Anthony Lawler said the principles and focus areas detail the ‘how and why we act’.
‘To safeguard Australians from unsafe products, empower the community with clearer information, and take firm, proportionate action when the rules are broken or ignored,’ he said.
The announcement comes amid a ‘dynamic regulatory environment’, with vaping, the rapid rise in weight-loss medication usage, and medicinal cannabis telehealth prescribing just some of the topics emerging in recent years.
Just last month, the TGA seized
$1 million of illicit vaping goods in Bendigo, an individual was issued infringement notices for
allegedly importing cosmetic injectables, and one company was issued infringement notices for the
alleged unlawful advertising of supplements.
RACGP President Dr Michael Wright welcomes the TGA ‘turning its mind to these emerging areas of risk’.
‘As GPs, we’ve seen a lot of fragmentation of care and some concerning behaviour from either single-disease or single-pathway clinics, so this is important,’ he told
newsGP.
‘The rules that GPs operate under, prescribing medications under the PBS, are pretty clear, but what we’ve seen is treatments provided outside of the PBS being less heavily regulated, and that isn’t in the best interest of patients or of GPs trying to provide high-quality care.
‘So, it’s pleasing to see that the TGA is looking at this range of areas.’
Dr Wright added that the compliance priorities come at a crucial time in healthcare regulation changes, including a recent
crackdown on vitamin B6 products.
‘It’s really highlighting that the use of medications is a lot more than what people think,’ he said.
‘There is such a broad range of medications being used that we need to make sure that it’s done safely.
‘It’s about putting patient safety first, which is what we do as GPs, but also making sure that there aren’t loopholes that can be exploited.’
The TGA’s compliance will apply across all regulated areas, including medical devices, prescription and non-prescription medicines, complementary and listed medicines, unapproved therapeutic goods, and other therapeutic goods.
It says its priority focus areas will be reviewed quarterly and updated as required via ‘intelligence-led and risk-based reviews’ of emerging or continued risks to public health and safety.
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