The Therapeutic Goods Administration (TGA) regulates the manufacture, supply and advertising of therapeutic goods in Australia, including medicines, medical devices and biological products.
What do you need to know?
The TGA has revamped its compliance and enforcement strategy, recently announcing its 2026 and 2027 compliance principles and priority focus areas.1 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. 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.
Unlike the TGA’s 2023-25 compliance priorities,2 which focused on specific product categories and risk areas (such as vaping and medicinal cannabis advertising), the 2026-27 compliance principles guide compliance across all regulated areas. Compliance is now framed around why and how the TGA operates (i.e. its compliance principles), alongside what it intends to target (i.e. its priority focus areas).
What is new?
Spotlight on compliance principles
Organised into five core compliance principles, the TGA’s new approach will be centred around:
- safeguarding therapeutic goods – through proactive scrutiny on unsafe products and disruption of falsified goods;
- educating to empower – with an emphasis on accessibility and countering misinformation online;
- protecting those most at risk – through culturally appropriate content and targeted strategies for at-risk populations;
- leveraging digital capability – by modernising compliance tools and addressing AI risks around misinformation; and
- strengthening enforcement – by taking swift action, responding promptly to emerging trends, and targeting non-compliance via digital channels,
With a reoccurring focus on social media, influencer content and online marketplaces given the rapid increase in this form of advertising, particularly as AI drives change.
The compliance principles should be read together with the Regulatory Compliance Framework,3 which outlines how the TGA encourages compliance and responds to contraventions of law.
Spotlight on priority focus areas
The TGA has also identified 12 categories of therapeutic goods that will be the focus of its 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; and
- vaping goods.
There are various similarities to the previous 2023-25 compliance priorities, however we note the new focus on:
- Listed medicine advertising – reinforcing requirements for clear, accurate, and mandatory product labelling of low-risk, non-prescription products (that include vitamin or mineral ingredients);4
- Software as a Medical Device (SaMD) – reflecting rapid innovation in technologies that affect software based medical devices;5 and
- 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.6
Importantly, the new framework provides increased flexibility, with the TGA set to review its focus areas quarterly to respond to rapidly emerging risks.
What does this mean?
The TGA’s updated approach reinforces its proactive and risk-based enforcement strategy, with particular scrutiny of online and social media content aimed at protecting Australian consumers.7 This coupled with the TGA’s recent updated guidance on using artificial intelligence for the advertisement of therapeutic goods (see our previous article here) shows a clear focus on online digital advertising. Safeguarding Australian consumers from unsafe products and ensuring clear product information in marketing also remains a clear TGA priority for the coming years.
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. In line with rapidly emerging risks, compliance will rely more than ever on the ability to identify risks and proactively respond to change.
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. TGA regulated products should be approved and listed on the Australian Register of Therapeutic Goods as appropriate, product safety standards should remain paramount, and product labels should be accurate and verified. Failing to do so could lead to swift and visible action by the TGA, including product recalls, infringement notices and fines, cancellation of products or court action.
For advice on understanding how the TGA’s new compliance and enforcement strategy will impact your business, contact Belinda Breakspear, Partner Digital & IP, at bbreakspear@mccullough.com.au or a member of our Life Sciences team (here).
[1] See TGA, ‘Compliance Principles 2026 and 2027 | Therapeutic Goods Administration (TGA)’.
[2] See TGA, ‘Import, Advertising and Supply Compliance Priorities 2023-25 | Therapeutic Goods Administration (TGA)’.
[3] See TGA, ‘Regulatory compliance framework | Compliance management enforcement | Therapeutic Goods Administration (TGA)’.
[4] See TGA, ‘Labelling and advertising for listed medicines | Therapeutic Goods Administration (TGA)’; TGA ‘Listed medicines | Therapeutic Goods Administration (TGA)’.
[5] See TGA, ‘Understanding regulation of software-based medical devices | Therapeutic Goods Administration (TGA)’.
[6] See TGA, ‘Sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ sunscreen | Therapeutic Goods Administration (TGA)’.