The Therapeutic Goods Administration (TGA) has released its Compliance Principles for 2026 and 2027, reinforcing a more proactive, risk-based enforcement approach across therapeutic goods regulation.
The principles outline how the regulator intends to prioritise compliance and enforcement over the next two years, with a focus on areas presenting higher public health risk, increased consumer exposure and rapid growth in digital and social media-driven promotion.
For the aesthetic and cosmetic medicine sector, the framework warrants close attention. Therapeutic goods used in cosmetic procedures are explicitly listed among the TGA’s priority focus areas from 1 January 2026, alongside weight loss medications, medicinal cannabis, sunscreens, Software as a Medical Device and listed medicine advertising.
According to the TGA, the principles are intended to reinforce public confidence in the safety, quality and appropriate use of therapeutic goods, while providing greater transparency about how compliance and enforcement activity will be prioritised and undertaken.
‘Our 2026 and 2027 compliance principles and focus areas detail the how and why we act: to safeguard Australians from unsafe products, empower the community with clearer information, and take firm, proportionate action when the rules are broken or ignored,’ said Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA.
The changes support ongoing collaboration with industry, healthcare professionals and consumers to promote voluntary compliance and take appropriate enforcement action where necessary.
TGA compliance principles for 2026-27
The TGA has identified five compliance principles that will guide its regulatory activity during 2026 and 2027. These principles are reproduced below.
1. Safeguarding therapeutic goods
Ensures protection from unsafe products and provides visibility to the public on action taken, via:
- Proactive scrutiny of advertising, especially in digital spaces.
- Disruption of unapproved and falsified goods, including those sold via e-commerce and social media.
2. Educate to empower
Proactively engaging with the public, industry and other stakeholders via guidance, education and other mechanisms, ensuring that we are:
- Inclusive by providing accessible education for consumers, health professionals, and industry.
- Countering misinformation and disinformation, particularly online, including via social media and influencer content.
3. Protect those most at risk
Protecting and engaging those most vulnerable via diverse and adaptive strategies, including:
- Targeted strategies for at-risk populations.
- Collaboration with community leaders for culturally appropriate content and to achieve compliance.
4. Leverage digital capability
Providing an active response to rising digital and technological risks, by:
- Modernising compliance tools, in part enabling enhanced monitoring of online activity.
- Addressing risks from AI-generated misinformation and deceptive endorsements.
5. Strengthen enforcement
Providing public and industry confidence in the work we do, by:
- Taking swift, proportionate action and responding to emerging trends.
- Increasing visibility of compliance actions.
- Targeting non-compliance via digital channels, including influencers and online marketplaces.
How the principles sit within the TGA’s existing enforcement framework
The TGA says these principles should be understood alongside its established Compliance management and enforcement framework, which sets out how regulatory compliance is monitored and enforced across the therapeutic goods sector.
According to the TGA, this framework underpins how it manages non-compliance with laws that govern the import, export, manufacture, advertising and supply of therapeutic goods in Australia. It reflects the broader statutory regime in the Therapeutic Goods Act 1989, through which the agency seeks to protect public health by ensuring that medicines, devices and biologicals are safe, effective and fit for purpose.
Key elements of the compliance management and enforcement framework
The framework makes clear that the TGA uses a range of tools and strategies to address non-compliance, including risk-based prioritisation and a mix of educational and enforcement actions:
Risk prioritisation – Compliance work is guided by an assessment of risk to public health and safety, the nature and seriousness of the conduct, and confidence in the regulated entity’s history and approach to compliance. Higher risk issues are prioritised for action.
Voluntary compliance through education – The TGA emphasises education and guidance to help sponsors, advertisers, manufacturers and other regulated parties understand their legal obligations. This includes published guidance, training materials and outreach.
Proportionate enforcement actions – When non-compliance is identified, the response may range from informal advice and warning letters to infringement notices, product recalls, injunctions or court action, depending on the severity and potential harm.
Transparency and reporting – The TGA publishes information on enforcement actions and outcomes to maintain accountability and support industry understanding of compliance expectations.
Under this approach, the TGA assesses reports of alleged non-compliance from internal monitoring, external intelligence and public complaints, and applies a structured risk assessment to determine the appropriate compliance pathway.
By articulating how compliance priorities will be set and how enforcement activity will be guided, the regulator aims to provide greater clarity to consumers, health professionals and industry alike about its approach to protecting public health.
