Articles

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.

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.

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.