Articles

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.

From 28 October 2024, Telstra and Optus are switching off their 3G networks. Medical devices and products like personal medical alarms could be affected by these closures.

SAHPRA and TGA have signed a Memorandum of Understanding which will strengthen collaboration between the two health product regulators.

The Prescription Medicines in Pregnancy database has been updated to include new and amended entries.

We are introducing strengthened product standards for therapeutic vapes including vaping substances, vaping substance accessories, vaping devices and vaping device accessories.

Patients 18 years or over can purchase therapeutic vapes from participating pharmacies without a prescription. A consultation with a pharmacist is required, and purchase is subject to certain conditions as well as any state and territory restrictions.

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

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.

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

The TGA is working with participating businesses to arrange the surrender of their vaping goods.

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.

We have issued an infringement notice to the New South Wales based company for the alleged supply of a complementary medicine that was missing a mandatory warning statement.

Summary of Changes made to transition eCTD AU Module-1 v3.1 to eCTD AU Module-1 v3.2

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.

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

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

A reminder about financial deadlines that are approaching for sponsors and manufacturers.

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.

Some medical device equipment could soon be affected as mobile network operators prepare to switch off their 3G networks.

A two-day joint enforcement operation has led to the seizure of more than 10,000 nicotine pouches and hundreds of illicit vaping goods.

Find out about our position on Messenger RNA (mRNA) technology.

An updated warning about the risk of sudden cardiovascular death has been added to the Product Information and Consumer Medicine Information documents for azithromycin.