26 February 2026
7 min read
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Earlier this year, the Therapeutic Goods Administration (TGA) announced its new compliance principles for 2026 and 2027. This re-aligns their approach to focus on five core principles, each supported by priority focus areas that will be reviewed quarterly to respond to emerging public health risks.
This represents a shift in the TGA’s approach to compliance, which was previously guided primarily by a list of priority areas focused on specific regulated products and behaviours, such as the unlawful import and supply or advertising of certain goods like nicotine vaping products and cannabidiol products. These priorities were largely product or category-based; set for defined periods; and updated less frequently. The TGA’s new approach is designed to provide overarching guidance to help shape compliance across the sector, along with outlining its priority areas of focus in relation to specific product types.
The TGA’s five core compliance principles for 2026 – 2027 are:
These compliance principles aim to guide how the TGA will allocate its compliance and enforcement activities across import, export, manufacturing, supply, advertising and post-market monitoring of therapeutic goods.
The TGA has also released a list of the specific product types it will focus on in the first quarter of 2026:
We have already seen the TGA take several actions so far this year in relation to the above priority focus areas. For example in February, the TGA issued infringement notices to Prime Medic Group Pty Ltd for alleged unlawful advertising of weight loss medicines; and has taken targeted action to seize illegally imported vape products.
The TGA’s next review of the product focus areas is scheduled for March 2026, with reviews to continue quarterly throughout 2026 and 2027.
The TGA’s 2026-2027 compliance principles broadly relate to the import, export, supply, manufacture and advertising requirements under the Therapeutic Goods Act 1989 (Cth) (Act).
We look at them in more detail below:
Safeguarding Therapeutic Goods: aims to ensure that the public is protected from exposure to unsafe products through proactively scrutinising advertising, particularly marketing content that appears on social media, and disrupting the availability of unapproved and falsified goods, including those sold and advertised to consumers on digital platforms. This follows from the TGA’s compliance priority in the 2023-2025 period pertaining to the regulation of substandard and falsified therapeutic goods but realigns this principle to ensure greater focus on digital platforms
Educate to Empower: ensures that the TGA actively engages with the public, industry and other stakeholders through guidance, education and other mechanisms to ensure accessible education about compliance and to counter misinformation and disinformation, particularly that which appears online via social media and ‘influencer’ content
Protect Those Most at Risk: this principle aims to protect at-risk populations using targeted strategies, such as collaborating with community leaders, to ensure culturally appropriate content is effectively disseminated to achieve compliance. This follows from the TGA’s compliance priority in the 2023-2025 period pertaining to the detection and deterrence of advertisement of traditional or alternative treatments to vulnerable populations, representing the continued need to protect at-risk communities
Leverage Digital Capability: ensures that the TGA responds in an agile manner to rising digital and technological risks through the modernisation of compliance and monitoring tools, as well as addressing the growing issue of misinformation and deceptive endorsements generated by AI
Strengthen Enforcement: aims to increase industry and public confidence in the TGA’s enforcement abilities by taking swift and proportionate action in their response to emerging trends, increasing the visibility of compliance actions, and targeting non-compliance via digital channels.
The TGA has a range of enforcement powers under the Act, including the ability to issue infringement notices and bring both civil and criminal proceedings for breaches of various provisions of the Act. TGA has specific powers to take enforcement action in relation to the unlawful advertising of therapeutic goods; and the making of misleading and deceptive statements in relation to therapeutic goods.
In 2025, among other things, we saw the TGA commence proceedings against:
The Strengthen Enforcement principal suggests that the TGA is committed to taking increased enforcement action against those who advertise therapeutic goods in contravention of the Act, particularly via digital channels.
As noted above, the TGA’s compliance priorities for the 2026-2027 period represent a shift away from focusing solely on the regulation of specific therapeutic goods. Rather, the TGA appears to now favour a ‘whole of sector’ approach, ensuring that enforcement activities and compliance priorities effectively respond to emerging issues in a strategic manner. The TGA aims to achieve this both through the refocusing of compliance and enforcement activities to five core areas, as well as the regular quarterly review of priority focus areas. By regularly reviewing emerging and continuing risks to public health and safety, the TGA intends to address and respond to compliance issues as they arise, specifically in relation to challenges emerging from AI-generated misinformation, digital platforms and online purchases.
The TGA’s 2026-2027 compliance principles and focus areas signal several practical implications for businesses who sponsor, manufacture, import or supply therapeutic goods.
The TGA’s renewed focus on non-compliance across online platforms likely reflects the increased use of digital and social media advertising by companies to market therapeutic goods directly to consumers. This shift responds directly to the heightened risk of misinformation and disinformation online. It is critical for businesses involved in importing or supplying therapeutic goods to understand that the Act prohibits the advertising of most therapeutic goods directly to consumers. Businesses should seek legal advice before engaging in any activity that poses risk of being considered an advertising activity of therapeutic goods, including the use of online platforms to educate customers about, or to assist in the sale of, specific therapeutic goods.
Businesses must also understand the regulatory status of their products. This includes confirming whether a therapeutic good is included on the Australian Register of Therapeutic Goods (ARTG), or if a relevant exemption applies. Businesses should be acutely aware that prescription-only medicines and certain substances, such as medicinal cannabis and weight loss injections, are prohibited from being advertised in Australia, and businesses may incur large fines and penalties if they are found in breach of this prohibition.
Practically, businesses should consider:
If you are a business involved in the import or supply of therapeutic goods, it is essential that your policies, processes, and procedures are adequate to ensure you do not inadvertently breach the Act.
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Disclaimer
The information in this article is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavour to provide accurate and timely information, we do not guarantee that the information in this article is accurate at the date it is received or that it will continue to be accurate in the future.
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