Compliance and enforcement
We monitor and enforce compliance with laws that regulate health products.
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How we manage compliance
We take a risk-based, evidence-drive approach that puts public safety first. Under the Therapeutic Goods Act 1989, we work to protect Australians by educating industry, assessing risks and taking action when needed.
Watch our video to learn more or explore our regulatory compliance framework.
Report a breach
We want to hear about:
- breaches of the Therapeutic Goods Act
- counterfeit products
- questionable practices
- non-compliant advertising related to therapeutic goods.
Know our compliance principles
We have re-aligned our approach to determining compliance priorities for 2026 and 2027. The new approach sees our priorities structured around five compliance principles, each supported by routinely reviewed priority focus areas. These principles guide how we address illegal import, export, manufacture, supply and advertising of therapeutic goods.
The five principles are:
- Safeguarding therapeutic goods
- Educate to empower
- Protect those most at risk
- Leverage digital capability
- Strengthen enforcement.
Learn more about our compliance principles
Find a compliance outcome
When we receive a report of a breach, we investigate and take action based on the level of risk to public health and safety. Our actions range from education and warnings to fines and legal action.
Understand the ways we respond to breaches of therapeutic good regulations and find the latest outcomes.
Page history
'Know our compliance principles' section updated.
Original publication.
'Know our compliance principles' section updated.
Original publication.
Latest alerts
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TGA continues to see imports of counterfeit Botox vials despite a previous warning issued in July 2025.
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TGA is issuing a safety advisory about the importation of unregistered GLP-1 products that are being promoted online for weight-loss.
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We are issuing a safety advisory regarding imported unregistered melatonin products following testing by TGA Laboratories.
Latest articles
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TGA statement on sunscreen labelling practices
This statement provides guidance to industry about how the Therapeutic Goods Act 1989 applies in relation to sunscreen labelling. -
The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027
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. -
Conviction for unlawful supply and advertising of black salve products
An individual has been sentenced for unlawfully advertising and supplying black salve and bloodroot capsules, and for advertising other unapproved therapeutic goods to treat serious conditions such as anxiety.
Latest publications
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The report cards show the progress made by the TGA in the 3 strategies that make up the Action Plan for Medical Devices.
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Clarifies requirements for SAS and AP applications for healthcare practitioners to access Category 2, 3, 4 and/or 5 (i.e. Schedule 8) medicinal cannabis medicines for their patients under the age of 18 years (paediatric patients).
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This plan outlines our compliance and education priorities for 2024-2025.