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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.

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 19 listed medicines

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.

A decision by the TGA will strengthen safety controls for products containing vitamin B6, and help to reduce the risk of nerve damage associated with the long-term consumption of high doses.

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.

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

The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group has published the draft Essential Principles and Content of Predetermined Change Control Plans document for public consultation.

The TGA has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms.

We have issued 5 infringement notices, totalling $99,000, to ACPharm Queensland Pty Ltd (ACPharm Queensland) for the alleged unlawful advertising of therapeutic goods.

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

The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Hwangbo SS Pty Ltd and [REDACTED] directions under section 42YT of the Therapeutic Goods Act 1989.

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

We have issued a warning to online delivery service providers not to breach Australian laws regarding the supply and advertising of vaping goods.

A coordinated crackdown on illegal vapes in southeast Queensland has led to a seizure of illegal vaping and tobacco products with a street value exceeding $8.8 million.

Professor Tony Lawler, Head of Australia’s Therapeutic Goods Administration, has been elected Chair of ICMRA, the International Coalition of Medicines Regulatory Authorities.

The TGA has issued a direction notice to Hwangbo SS Pty Ltd and its executive officer in relation to vaping products under section 42DZK of the Therapeutic Goods Act 1989.

We’re pleased to announce that improvements for industry users will roll out by the end of October.

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).

The TGA has issued a direction notice to Iquality Group Pty Ltd and its executive officer in relation to the advertising of vaping goods under section 42DZK of the Therapeutic Goods Act 1989.

The TGA has issued a direction notice to Iget Brands Pty Ltd and its executive officer in relation to the advertising of vaping goods under section 42DZK of the Therapeutic Goods Act 1989.