Articles

The second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety.

The Minister for Health and Aged Care, the Hon Mark Butler MP, introduced a bill that aims to reduce the widespread availability of vapes by controlling all levels of the supply chain.

Our investigation into the risk of retinal vasculitis and/or retinal occlusive vasculitis in patients being treated with faricimab (Vabysmo) found that stronger warnings regarding this risk were needed in the Product Information (PI) and Consumer Medicine Information (CMI).

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

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

Infringement notices for $82,500 have been issued to Caruso’s Natural Health Pty Ltd, for an alleged failure to hold information or evidence to support therapeutic uses in relation to medicines.

We have updated our guidance on advertising cosmetic injectables to ensure advertising rules are applied consistently across all industries that deal with therapeutic goods.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.

The TGA and Health Canada have signed a Memorandum of Understanding to further increase collaboration and reliance on Good Manufacturing Practice inspections conducted in countries outside each other's borders.

Therapeutic goods and records have been seized from a pharmacy in Melbourne. This is part of our investigation into the alleged unlawful manufacture, supply and export of therapeutic goods.

From 3 June 2024, we will be using a new Good Manufacturing Practice (GMP) guide for medicines, active pharmaceutical ingredients and sunscreens.

The targeted consultation is part of a proposal to change the Therapeutic Goods Regulations 1990 to mitigate safety risks in the compounding of GLP-1 RAs.

The TGA has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines

The TGA has issued 4 infringement notices totalling $75,120 to Liquefy Health Pty Ltd for the alleged unlawful importation and advertising of unapproved complementary medicines.

Medicines Safety Update - Information for health professionals

Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.

The TGA has issued 13 infringement notices totalling $42,900 to a New South Wales-based individual for the alleged unlawful advertisement and supply of erectile dysfunction medicines.

The Australian Border Force (ABF) and partners have seized more than five and a half million cigarette sticks and prevented hundreds of thousands of prohibited vapes and drug items from reaching the streets of Sydney.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

Medicines Safety Update - Information for health professionals

The TGA has issued 18 infringement notices totalling $157,752 to Kilpatrick & Douglas Pty Ltd and two directors, for the alleged unlawful advertising of nicotine vapes

On 1 January 2024, as part of the reforms to the regulation of vaping products, the Advertising Permission for Nicotine was repealed.

The TGA with the assistance of NSW Police have seized 478 sport supplements containing potentially dangerous substances from a Sydney retail store.

We issued an infringement notice for $13,320 to the New South Wales based company Marvel Health (Australia) Pty Ltd. This was for an alleged failure to comply with a notice to provide information about a complementary (listed) medicine.