Articles

More prominent warnings are being added to the product information (PI) and consumer medicine information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects

There may be an increased risk of neurodevelopmental disorders in children born to men who have taken sodium valproate in the 3 months before conception.

Following a request from the sponsor to reconsider their decision, the TGA has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine were not satisfactorily established.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2025, which commenced on 1 March 2025

From 1 March 2025, sponsors of vaping goods will be able to use a new online form of the sponsor notice.

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

We are updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI)

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

The TGA has released a literature review of certain active ingredients used in sunscreens.

Australians who use tanning products containing ‘melanotan’ are at risk of serious health problems.

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

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We have issued a combined total of $396,000 in infringement notices to 20 Melbourne retail businesses for the alleged unlawful supply of vaping goods.

Additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events.

This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.

This instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.

This instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989.

The defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge.

Recall reforms program update and preview of the PRAC Version 1.0.

TCMs sold in Australia are carefully regulated to ensure safety and quality.

We have issued infringement notices totalling $37,560 for the alleged unlawful possession of a commercial quantity of vaping goods.

The TGA and cooperating agencies have seized a large volume of alleged illicit vapes, tobacco and other substances in coordinated operations across Australia.

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

MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.

Find out about new requirements for labels of injectable electrolyte medicines and updates to guidance for medicine sponsors.