Articles

The Adverse Event Management System (AEMS) has moved to the cloud, delivering improved system stability and security.

The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for the import, export, manufacture, supply and advertising of therapeutic goods in Australia.

An individual has been sentenced for unlawfully advertising and supplying black salve and bloodroot capsules, and for advertising other unapproved therapeutic goods to treat serious conditions such as anxiety.

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

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

Have you experienced an issue with a medicine or medical device?
Every report is important. Reports help us monitor the safety of medicines, vaccines and medical devices.

Product warnings across the GLP-1 RA class of medicines have been aligned to ensure consistent information regarding the potential risk of suicidal thoughts or behaviours.

Our investigation into the potential for reduced effectiveness of oral contraception during initiation or dose escalations with Mounjaro (tirzepatide) has found that this association could not be ruled out.

Some medical devices could be affected by the end of support for the Microsoft Windows 10 operating system.

The Product Information for denosumab products indicated for the treatment of osteoporosis have been updated to strengthen the existing warning for multiple vertebral fractures following discontinuation or delay of treatment.

This joint statement from the Head of the TGA and Australia’s Chief Medical Officer (CMO), provides you with clear, evidence-informed advice about vaccine safety.

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

We have made changes to our website to make finding information easier. These improvements are based on your feedback.

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

New warnings on hepatotoxicity risk and monitoring recommendations have been added to the Product Information for Veoza (fezolinetant).

There is growing interest in using software and artificial intelligence (AI) in healthcare settings, including where it is used to support people with mental health conditions.

We have received 2 serious adverse event cases in neonates in which EMLA (topical prilocaine/lidocaine cream) was applied for a circumcision procedure. Both cases were likely to have involved overdose.

Results of our investigation into the safety and efficacy of Vyvanse.

We have issued 3 infringement notices totalling $11,268 to a Victorian-based individual for allegedly importing unapproved prescription-only medicines.

On 23 September 2025 the TGA made the decision to approve the registration of the lecanemab (LEQEMBI).

Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims.

A review of the GMP Clearance backlog reduction strategies that have been implemented and ongoing monitoring and reporting communication.

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

As per our previous statement on 21 August 2025, the TGA is currently investigating a CHOICE report on Sunscreen SPF testing. This update provides information for consumers.

The TGA is currently investigating the CHOICE report on Sunscreen SPF testing, as per our previous statement on 21 August 2025. This update outlines the steps that sunscreen sponsors should take if they identify a problem with their product.