The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

The Therapeutic Goods Administration (TGA) has released its compliance principles for the next 2 years, setting out a refreshed approach to compliance and enforcement to protect public health.

The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for the import, export, manufacture, supply and advertising of therapeutic goods in Australia.

Following a review of the 2023-2025 Compliance Priorities, the TGA identified opportunities to strengthen how these priorities are set and reviewed. This includes changes to how often priority areas are assessed and how emerging risks are addressed.

The new approach applies across all TGA regulated areas, including medical devices, prescription and non-prescription medicines, complementary and listed medicines, unapproved therapeutic goods, and other therapeutic goods. This whole-of-sector approach ensures compliance and enforcement activities are strategic, collaborative, and responsive to emerging issues.

These changes reflect the TGA’s commitment to proactive and responsive regulation of therapeutic goods. They support ongoing collaboration with industry, healthcare professionals and consumers to promote voluntary compliance and, where necessary, take appropriate enforcement action to protect the public from harm.

Compliance and enforcement activities will be guided by 5 core principles and supported by regularly reviewed priority focus areas. The framework enables an agile response to emerging challenges and ensures a risk-based, rapid approach to high-impact issues, including those arising from misinformation, digital platforms and online purchases.

TGA’s compliance principles will be reviewed every 2 years to ensure they remain relevant and responsive to the dynamic regulatory environment, with the supporting focus areas enabling a responsive approach to compliance and enforcement efforts. The next review is scheduled for late 2027.

"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.

TGA compliance principles

The TGA’s compliance principles from 1 January 2026 to 31 December 2027 are:

• Safeguarding therapeutic goods
• Educate to empower
• Protect those most at risk
• Leverage digital capability
• Strengthen enforcement

Urgent compliance issues will continue to be addressed as they arise, ensuring public health protection remains paramount.

TGA priority focus areas to 31 March 2026

The TGA’s compliance and enforcement activities are currently focused on 12 key areas:

1. Direct to consumer in vitro diagnostic (IVD) kits
2. Erectile dysfunction medications
3. Foetal dopplers
4. Listed medicine advertising
5. Medicinal cannabis
6. Melatonin
7. Software as a medical device
8. Substandard and falsified therapeutic goods
9. Sunscreen
10. Weight loss medications
11. Therapeutic goods used in cosmetic procedures
12. Vaping goods.

Priority focus areas will be reviewed quarterly and updated as required via intelligence-led and risk-based reviews of emerging or continued risks to public health and safety.

Our compliance principles and focus areas should be read alongside our Regulatory Compliance Framework, which describes our approach to compliance, including how we encourage voluntary compliance and respond to alleged contraventions of the law.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices or suspected non-compliant advertising on the TGA website.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400