Compliance and enforcement
We monitor and enforce compliance with laws that regulate health products.
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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The Therapeutic Goods Administration (TGA) is advising consumers that several sexual enhancement products have been found to contain undeclared ingredients and may pose a serious risk to your health.
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We are advising consumers that ‘Pharmatech’ branded MK-677 capsules (containing ibutamoren) may pose a serious risk to your health and should not be taken.
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We are advising consumers that Artri Ajo King tablets may pose a serious risk to your health and should not be taken.
Latest articles
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TGA statement on Consumer NZ sunscreen testing
We are aware of recent sunscreen testing undertaken by Consumer NZ, which reported Sun Protection Factor (SPF) results for a number of sunscreens. -
Court orders CDA Clinics QLD and its former director to pay $6.95 million for unlawful advertising of medicinal cannabis
The Federal Court of Australia has ordered CDA Clinics QLD Pty Ltd (CDA Clinics) to pay $6.5 million in civil penalties for the unlawful advertising of medicinal cannabis to the public. -
Outcome of digital scribe review
Outcomes of our review of digital scribes supplied in Australia.
Latest publications
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Outcomes of the review of digital scribes supplied in Australia.
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This report summarises the outcomes of the Pharmacovigilance Inspection Program in the 2-year period. The deficiencies identified are presented along with case studies of critical deficiencies from this reporting period, to support medicine sponsors in the continual improvement of their pharmacovigilance systems.
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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.