Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA), has released its Compliance Principles for 2026 and 2027.
The refreshed approach to compliance and enforcement will be guided by 5 core principles and 12 priority focus areas that will be regularly reviewed. The priorities update coincides with our observed increase in regulatory engagement and enforcement by the TGA.
The updated compliance principles
The TGA has articulated five compliance principles for the period 1 January 2026 to 31 December 2027.
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Safeguarding therapeutic goods
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There will be a focus on protection of the public from unsafe products by:
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Educate to empower
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The TGA has committed to proactively engage with the public, industry and stakeholders through guidance and education, including by providing accessible education for consumers, health professionals and industry, and countering misinformation and disinformation, particularly online (including via social media and influencer content). |
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Protect those most at risk
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Protecting and engaging vulnerable groups will be achieved by adopting targeted strategies for at-risk populations and collaborating with community leaders to ensure that content is culturally appropriate and framed to achieve compliance. |
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Leverage digital capability
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The TGA is intending to respond to rising digital and technological risk by modernising compliance tools to enable enhanced monitoring of online activity and addressing risk that arises from AI-generated misinformation and deceptive endorsements. |
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Strengthen enforcement
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We expect stronger enforcement action to be taken, with a focus on swift, proportionate action and responses to emerging trends. The TGA intends to increase visibility of its enforcement action and with a focus on non-compliance via digital channels (including influencers and online marketplaces). Urgent compliance issues will continue to be addressed as they arise. |
Priority focus areas
12 key areas will be in focus for compliance and enforcement activity.
What has changed?
Changes to the priority subject-matter list
Several themes continue (e.g., vaping goods, medicinal cannabis, and substandard and falsified goods will continue to be in the TGA’s sights). However, a shift to focus on SaMD, direct-to-consumer IVD kits, foetal dopplers, melatonin, erectile dysfunction medications, sunscreen, and listed medicine advertising represents a significant change. The 2023–25 priorities of unlawful advertising of psilocybin and MDMA and medicines and devices advertised as traditional or alternative treatments have not been take forward.
More frequent review and an “agile” response
Under the new framework, the focus areas will be reviewed quarterly and in light of intelligence-led and risk-based reviews. This is an increase in the cadence of reviews than under the earlier framework and we anticipate additional priority areas may be added to the list during the year.
Reframed emphasis on digital channels, misinformation and AI
The 2026–27 principles expressly include leveraging digital capability (modernised tools, enhanced monitoring of online activity, and addressing AI-generated misinformation and deceptive endorsements) and targeting non-compliance via digital channels (including influencers and online marketplaces).
While the 2023–25 priorities referred to routine monitoring of advertising on digital platforms and social media, the new framework elevates these issues to core principles, and expressly addresses AI and deceptive endorsements.
Practical steps to consider
Early investment in compliance materially reduces regulatory risk.
- Map therapeutic goods and promotional activity to the current focus areas, particularly where any part of the business involves direct-to-consumer IVDs, online advertising, or software functionality that may meet the definition of a medical device (SaMD).
- Conduct a targeted advertising and content review across channels (including social media, influencers and online marketplaces), having regard to the TGA’s likely proactive scrutiny of advertising in digital spaces and its intended focus on deceptive endorsements and online misinformation.
- Review governance and escalation procedures so that potential issues can be assessed and remediated quickly, noting the TGA’s risk based and graduated approach to enforcement (that takes into account risk of harm posed by the non compliance, the nature of the non compliance, the vulnerability of the affected population, and size, reach, and compliance history). Initial responses to TGA enforcement action are critical.
- Ensure internal training and guidance materials are current, consistent with the TGA’s likely focus on promoting voluntary compliance through education and accessible information.
