TGA's compliance principles for 2026 and 2027: A focus on proactive and risk-based enforcement in the digital landscape

Following a review of its compliance principles for 2023 to 2025, the Therapeutic Goods Administration (TGA) has released its compliance principles for 2026 and 2027. The principles outline the regulator's approach to the monitoring and enforcement of regulatory compliance with respect to the import, export, manufacture, supply and advertising of therapeutic goods in Australia. The 2026 / 2027 principles continue the TGA's focus on consumer safety in the context of advertising and supply of products to consumers online, including via social media and online marketplaces.

Five core principles

For the period 1 January 2026 to 31 December 2027, the following five core principles will guide compliance and enforcement activities by the TGA across all relevant areas of its remit, including medical devices, prescription and non-prescription medicines, and other therapeutic goods.

1. Safeguarding therapeutic goods

The TGA has committed to continuing to ensure protection of the public from unsafe products, specifically with respect to the advertising and sale of unapproved and falsified goods via digital platforms, including e-commerce and social media.

This is a continued area of focus for the TGA, where the importation, advertising and supply of unapproved and high-risk medicines and medical devices in the wellness and beauty industries, such as performance enhancers, was a compliance priority in the 2023 to 2025 period.

2. Educate to empower

The TGA will proactively engage with the public, industry and other stakeholders via (among other things) guidance and education to counter misinformation and disinformation, including online social media and influencer content, and provide accessible education for consumers, healthcare professionals, and industry.

3. Protect those most at risk

The TGA is committed to utilising "diverse and adaptive" strategies to protect vulnerable consumers most at risk of harm from products. The regulator will employ targeted strategies for at-risk populations and collaborate with community leaders in preparing content that is culturally appropriate to facilitate compliance. Any assessment by the TGA as to the risk of harm presented by a product to consumers will be informed by the way in which the product is used or promoted for use, the nature of the breach, the vulnerability of the target market, as well as the size, reach and compliance history of the relevant company or industry sector.

4. Leverage digital capability

The TGA will focus on actively responding to increased digital and technological risks by "modernising compliance tools", including improved monitoring of online activity. The TGA also aims specifically to address risks from AI-generated misinformation and misleading endorsements.

5. Strengthen enforcement

Finally, the TGA is committed to increasing public and industry confidence in its activities, including by "taking swift, proportionate action" in responding to developing trends, facilitating transparency of compliance actions, and targeting non-compliance in the digital environment, including by social media influencers and online marketplaces.

Priority focus areas

These five core compliance principles are each supported by 12 priority focus areas.  Those areas will be regularly reviewed by the TGA on a quarterly basis and updated as required. From 1 January 2026, the 12 key areas are direct to consumer in vitro diagnostic (IVD) 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, and vaping goods.

We have already seen the TGA in action with respect to:

1. Weight loss medications – The TGA has issued a number of infringement notices to businesses for advertising of prescription-only weight loss medications on their websites (some examples are here and here). We expect that the TGA will continue to monitor the advertising and supply of prescription-only weight loss medications to ensure compliance with the current regulatory framework, given the increased activity and continued growth and development in this industry sector, as well as significant public and social media attention.

2. Software as medical devices – The TGA is continuing to monitor this space to ensure the current regulatory framework is fit for purpose and can effectively detect, mitigate and address the risks presented by the increased use of AI. One such example is the diagnostic and treatment features of digital scribes (also known as AI scribes or ambient scribes), which may cause software to fall into the definition of a "medical device" under the Therapeutic Goods Act 1989 (Cth). The TGA published its Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report in July 2025, following public consultation, and also publishes a list of AI-enabled medical devices in the Australian Register of Therapeutic Goods.

3. Substandard and falsified therapeutic goods – The internet provides a platform by which individuals and businesses can easily advertise and supply unapproved, substandard and counterfeit therapeutic goods directly to consumers, presenting serious safety risks. We expect the TGA will continue to crack down on the advertising and supply of counterfeit and black market prescription-only products, such as cosmetic injectables (as well as weight loss medications), having recently issued an infringement notice to an individual in December 2025 for importing and advertising counterfeit botulinum toxin type A (commonly known as "Botox").

4. Sunscreen – Again, we expect the TGA will remain active in this space after the recall of a number of sunscreen products by sponsors in the second half of 2025 following preliminary testing evidence which indicated that the SPF levels of their products may be lower than claimed on labelling. It remains unclear at this stage whether the TGA will take any enforcement action against the sponsors of the sunscreens; however, the regulator has flagged that other sunscreens may be added to the products recalled to date and will provide updates in this regard.