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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.

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

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.

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.

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

We have published a list of medical devices in the ARTG that incorporate artificial intelligence (AI) or machine learning (ML) technologies.

Know how we manage compliance of AI and software products that meet the definition of a medical device.

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

We have published information to clarify when digital scribes - also referred to as AI scribes or ambient scribes - are regulated as medical devices in Australia.

There has been an increase in the illegal advertising and online sales of nicotine pouches, with many of these products being imported from overseas.

The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).

We have published our Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report.