Articles

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.

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

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

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

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

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

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.

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.

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

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.

The company imported medical devices not included in the Australian Register of Therapeutic Goods. They supplied these devices to a national retailer, who then sold them to the public.

We have accepted an enforceable undertaking from 2San Pty Ltd in relation to breaches of the Therapeutic Goods Act 1989. This relates to the company's unlawful import and supply of medical devices.

The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 will take effect on 1 July 2024, following passage through the Australian Parliament.

Find out about regulatory changes to a range of medical devices and application audit requirements.