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We have issued 11 infringement notices totalling $43,560, to 6 individuals, for the alleged importation and unlawful advertising of therapeutic goods.

The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).

We conducted targeted compliance reviews of selected listed medicines using indications related to diarrhoea that are required to display a warning statement

On 23 January 2026 we, with support from Victoria Police, executed a search warrant at a pop up retail store in Inverloch, Victoria.

This statement provides guidance to industry about how the Therapeutic Goods Act 1989 applies in relation to sunscreen labelling.

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.

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.

Information for health professionals about medicines with safety related updates to their Product Information.

We have issued 2 infringement notices totalling $37,560 to Booty N Buff Nutrition Caringbah Pty Ltd (Booty N Buff Nutrition) for the alleged unlawful advertising of therapeutic goods in contravention of the Therapeutic Goods Act 1989 (the Act).

On 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (YEYTUO).

We have updated the rules for lawfully handling vaping products in Australia. These changes make it clearer for businesses that need to lawfully possess and supply vaping goods as part of their operations.

The Prescription Medicines in Pregnancy database has been updated to include new entries.

Information for health professionals about medicines with safety related updates to their Product Information.

We have received an internationally recognised designation from the World Health Organization (WHO), reaffirming our role as a trusted global medicines regulator ensuring medicines and vaccines meet the highest international standards for quality, safety and efficacy.

On Thursday 18 December, following an investigation into the suspected illegal supply and manufacture of vaping substances, the TGA led a major operation targeting illicit vaping products at 2 locations in Bendigo.

We have issued 2 infringement notices totalling $7,716 to a Queensland-based individual for the alleged unlawful importation of counterfeit botulinum toxin type A and the unlawful advertising of cosmetic injectables.

We have issued 5 infringement notices, totalling $19,800, to a NSW-based individual, for the alleged unlawful importation of unapproved prescription-only medicines in contravention of the Therapeutic Goods Act 1989.

We’re seeking information from people who use or recommend digital mental health tools, as part of a review into how these software-based products should be regulated in Australia.

We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2025, which commenced on 10 December 2025.

We have issued an infringement notice, to the value of $19,800, to PERDAY'S HEALTH FUNCTIONAL FOOD (AU) PTY LTD (Perdays Australia) for the alleged unlawful advertising of a listed medicine.

Have you experienced an issue with a medicine or medical device?
Every report is important. Reports help us monitor the safety of medicines, vaccines and medical devices.

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 19 listed medicines

Product warnings across the GLP-1 RA class of medicines have been aligned to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours.

Our investigation into the potential for reduced effectiveness of oral contraception during initiation or dose escalations with Mounjaro (tirzepatide) has found that this association could not be ruled out.