Articles

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.

This instrument is made under section 39 of the current Poisons Standard.

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.

The GMP Guidelines on Chapter 1 - Pharmaceutical Quality System are being updated to reflect contemporary Quality Risk Management principles and further improve how Product Quality reviews are performed.

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 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.

This Legislation Amendment makes changes to the way testing of goods is conducted under the Therapeutic Goods Regulations 1990.

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 18 listed medicines

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2025, which commenced on 19 September 2025.

The TGA has identified a discrepancy between the wording of the ‘POTAS1’ warning statement available in the Code Tables compared to the requirements for potassium chloride and glucosamine sulfate potassium chloride in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination).