Articles

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

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.

Information about the TGA's safety monitoring of COVID-19 vaccines.

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.

Doughbot Enterprises and its sole director have accepted an enforceable undertaking to not advertise nicotine vaping products or support their advertising.

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

TGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.

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 approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.

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.

Information about the TGA's safety monitoring of COVID-19 vaccines.

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 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 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.

TGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.

TGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.