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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).

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

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.

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.

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

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 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 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.

Help shape the future regulation of digital mental health tools by sharing how you use, access and assess the safety and effectiveness of apps and AI tools.

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.

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

Had an issue with a medicine or medical device? Your report matters and helps us monitor safety.

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.

A decision by the TGA will strengthen safety controls for products containing vitamin B6, and help to reduce the risk of nerve damage associated with the long-term consumption of high doses.

Some medical devices could be affected by the end of support for the Microsoft Windows 10 operating system.

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

The Product Information for denosumab products indicated for the treatment of osteoporosis have been updated to strengthen the existing warning for multiple vertebral fractures following discontinuation or delay of treatment.