Therapeutic goods regulation
The regulatory framework reflects and upholds the Australian community’s expectations around the safety and quality of therapeutic goods on the market.
Latest alerts
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Consumers and health professionals should be aware that counterfeit Ozempic-labelled pens have been imported into Australia. These pens may pose a serious health risk and should not be used. There are clear inconsistencies from the original product to look out for.
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Dark Horse Capsules pose a serious risk to your health and should not be taken.
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The product tested is not listed in the ARTG and has not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation.
Latest articles
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Our Guidance pages have changed
We have introduced new features to improve your experience using Guidance on our website. -
TGA's decision to not register lecanemab (LEQEMBI)
TGA has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease). -
South African and Australian health product regulators to share regulatory information and expertise
SAHPRA and TGA have signed a Memorandum of Understanding which will strengthen collaboration between the two health product regulators.
Latest publications
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Read our 2024 stakeholder survey report, which aims to improve the way we work with our stakeholders.
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Communique from the meeting of the TGACC
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This Cost Recovery Implementation Statement (CRIS) 2024-2025 provides information on how we implement, and cost recover our regulatory activities.