Articles

The dual labelling period for some medicine ingredients is ending on 30 April 2025.

We are seeking applications from professionals with relevant expertise in medicine and science, and consumers with relevant expertise in consumer perspectives and issues.

We will be initiating targeted compliance reviews of selected listed medicines that are required to display a warning statement

Updates further highlight potential risks of mood-related changes and sexual disorders.

The Prescription Medicines in Pregnancy database has now been updated to include the following new entries:

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

Listed medicine compliance review reports database March 2025 update

Your participation in this online activity will help us create a more user-friendly website that works better for everyone.

The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies.

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.

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

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.

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

Your feedback is essential to shaping a user-friendly website that works better for everyone.

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

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

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

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

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

We have introduced new features to improve your experience using Guidance on our website.

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