Articles

This instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.

This instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.

This instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989.

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

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

The 3G network shutdown may impact certain medical devices. Consumers, healthcare providers, manufacturers, and suppliers should take precautions to prevent disruption in essential medical services.

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.

The Federal Court of Australia has ordered Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020.

This instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Two new quality standards, one for MDMA and another for psilocybine, have been published.

The TGA has been reviewing the safety and performance of spinal cord stimulator (SCS) devices.

This instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.

This instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.

Some changes are rolling out soon to improve your experience using guidance on our website. We’re aiming to make our content clearer, more accessible and easier to navigate.

TGA has commenced proceedings in the Federal Court of Australia against Key Promotional Products Pty Ltd, and an individual, for allegedly importing and supplying unapproved rapid antigen test kits

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.

One of the key functions of the Therapeutic Goods Administration (TGA) is to closely monitor the safety of therapeutic goods. But to properly monitor safety, we need everyone to report any side effects and problems they have.

The second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety.

The Minister for Health and Aged Care, the Hon Mark Butler MP, introduced a bill that aims to reduce the widespread availability of vapes by controlling all levels of the supply chain.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.

The TGA has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines

The Australian Border Force (ABF) and partners have seized more than five and a half million cigarette sticks and prevented hundreds of thousands of prohibited vapes and drug items from reaching the streets of Sydney.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

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