Compliance and enforcement
We monitor and enforce compliance with laws that regulate health products.
This page is in Beta testing. We welcome your feedback and suggestions as we look to improve this page.
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 priorities
Our compliance priorities for 2023-2025 include the illegal import, advertising or supply of the following products:
- nicotine vaping products
- medicinal cannabis and beauty products
- poor quality and fake therapeutic products
- traditional and alternative medicines.
Other areas of focus include software and AI medical device compliance, pharmacovigilance and good clinical practice inspection programs, among others.
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.
Latest alerts
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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.
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We are issuing a safety advisory about the increasing importation and use of unregistered oral methylene blue (methylthioninium chloride) products in Australia.
Latest articles
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TGA releases updated social media advertising guidance to support improved compliance
The TGA has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms. -
ACPharm Queensland issued infringement notices for alleged unlawful advertising of therapeutic goods
We have issued 5 infringement notices, totalling $99,000, to ACPharm Queensland Pty Ltd (ACPharm Queensland) for the alleged unlawful advertising of therapeutic goods. -
Enforceable direction: Hwangbo SS Pty Ltd and [REDACTED]
The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Hwangbo SS Pty Ltd and [REDACTED] directions under section 42YT of the Therapeutic Goods Act 1989.
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.
Open consultations
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Consultation: Provisions to regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) processes
We are seeking industry feedback on proposed amendments to strengthen the legal framework governing TMFs for blood and blood components, and PMFs for Type II plasma-derived products.