Articles

The TGA has published an independent expert report examining the incidence of serious injury and death from intentional paracetamol overdose.

The TGA has approved the first two nasal combination self-tests (for use at home) that detect both COVID-19 and influenza viral infections in humans.

TGA approves asciminib and faricimab through the Access New Active Substance Work-Sharing Initiative

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022.

The TGA has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd

WA-based company World Environmental Technologies Pty Ltd fined $13,320 for alleged unlawful importation of ivermectin, a prescription-only medicine.

TGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adults

The TGA has provisionally approved Moderna's bivalent COVID-19 vaccine, elasomeran/imelasomeran (SPIKEVAX Bivalent Original/Omicron) for use as a booster dose in adults 18 years and over.

Section 7 declarations provide greater clarity for consumers, industry and regulators about whether a product is a therapeutic good.

The TGA has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID.

Update to the manufacturing principles for medicinal products

TGA's participation in INTERPOL's Operation Pangea, which tackles the trade of illicit and counterfeit therapeutic goods worldwide, led to intercepting more than $2 million of illegally imported products.

Victoria-based Doughbot Enterprises fined $87,312 and undertakes to comply with advertising rules for nicotine vaping products.

TGA grants provisional determination for sabizabulin for the treatment of COVID-19

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

The TGA has issued a $2,664 infringement notice to a WA-based individual for allegedly importing liquid nicotine for use in nicotine vaping products.

The TGA has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).

The Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.

The TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.

TGA commences evaluation of Pfizer's COVID-19 vaccine (COMIRNATY) for children aged 6 months to less than 5 years

The TGA has issued an infringement notice to a NSW-based individual for allegedly advertising nicotine vaping products for sale via their website.

The TGA has issued a direction notice to Phenix Health Pty Ltd (Phenix) to cease promoting the use and supply of nicotine vaping products to Australian consumers.