Articles

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.

We are advising sponsors of updates to the Generic Medicines Work-Sharing Initiative (GMWSI) operational procedures.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.

The TGA is updating acceptable intake information for nitrosamine impurities in medicines.

Following an extensive internal and external consultation process, we have adopted the following 13 international scientific guidelines.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.

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

The Scheme allows businesses to surrender certain quantities of vaping goods that were lawful prior to 1 July 2024. Notify us before September 2024 to participate.

Infringement notices were issued to businesses and individuals for the alleged unlawful advertising of prescription-only medicines on their websites.

TGA has issued 3 infringement notices totalling $56,340 to News Life Media Pty Ltd for alleged unlawful advertising of medicinal cannabis on their popular lifestyle website Body+Soul.

Six monthly report – supply of unapproved therapeutic goods by a sponsor.