The Therapeutic Goods Administration (TGA) has signalled it will have sunscreen SPF levels, medicine advertising and medical software as key compliance targets this year.
McCullough Robertson Lawyers Digital & IP Partner Belinda Breakspear said the TGA had recently announced its compliance principles and priority focus areas for 2026 and 2027.
She said the compliance priorities had similarities to the 2023-25 document but there was fresh attention on the following.
Listed medicine advertising – reinforcing requirements for clear, accurate, and mandatory product labelling of low-risk, non-prescription products (that include vitamin or mineral ingredients)
Software as a Medical Device – reflecting rapid innovation in technologies that affect software-based medical devices
Sunscreens – particularly following recent CHOICE SPF testing and the TGA’s ongoing investigation into sunscreens with significantly lower test results than the claimed SPF level
The TGA regulates the manufacture, supply and advertising of therapeutic goods in Australia, including medicines, medical devices and biological products.
Ms Breakspear said the TGA had identified the following 12 categories of therapeutic goods as the focus of compliance and enforcement activities.
- 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
- Sunscreens
- Weight loss medications
- Therapeutic goods used in cosmetic procedures
- Vaping goods
“These compliance principles and priority focus areas relate to the import, export, supply, manufacture and advertising requirements of the Therapeutic Goods Act 1989 (Cth) (TGA Act), and provide refreshed guidance on the TGA’s regulatory focus over the next two years,” Ms Breakspear said.
“The update also reflects the TGA’s continued focus on industry sectors with high levels of non-compliance, and responds to concerns of the broader community.”
Ms Breakspear said the TGA had a reoccurring focus on social media, influencer content and online marketplaces.
This was a result of the rapid increase in this form of advertising, particularly as Artificial Intelligence drove change.
“Given the dynamic nature of the new framework, organisations should ensure they understand their legal obligations under the TGA Act and be prepared to adapt stringent compliance strategies and practices, particularly those businesses that operate in the TGA’s priority focus areas listed above,” Ms Breakspear said.
“Organisations involved in the manufacture, supply, or advertising of therapeutic goods in Australia, should ensure they implement processes to proactively review advertising content and marketing practices for TGA compliance, including social media and influencer content.
“Advertising content should be accurate, verified, transparent, balanced and not misleading.”
For advice on understanding how the TGA’s new compliance and enforcement strategy will impact your business you can contact Ms Breakspear or a member of the McR Life Sciences team (here).
