Articles

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

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

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.

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.

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

Prescription lenses supplied only for refractive correction are now exempt from inclusion in the Australia Register of Therapeutic Goods (ARTG) prior to import, export or supply in Australia.

The Bill is part of reforms to prevent and reduce the use of vapes in Australia, unless clinically appropriate for stopping smoking or the management of nicotine dependence.  

Annex 16 will apply to therapeutic goods manufactured from 3 September 2024. Find out about the transition period.

We are reviewing the safety information supporting notifications of the highest-risk medical devices used in first-in-human clinical trials. Find out how the changes we have implemented impact you as a sponsor. 

Consistent with recent EMA updates of acceptable intakes for established N-nitrosamines, the TGA has published updated acceptable intakes for nitrosamines in medicines.

We will adopt the 2021 Sunscreen Standard into therapeutic goods legislation. If you're a manufacturer or sponsor, find out what this means for you.

Information about Real World Evidence (RWE) use in regulation of medicines and medical devices.

The Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.

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

On 1 January 2024, as part of the reforms to the regulation of vaping products, the Advertising Permission for Nicotine was repealed.

We are advising sponsors, who are intending to register new prescription medicines, of a new way to pursue work-sharing for priority applications.

We have launched a new search feature in the Adverse Event Management System (AEMS) portal.  As a sponsor, you can access adverse event reports about your medicines and biologicals.

It's #MedSafetyWeek, a global movement to encourage the reporting of medicine side effects (known as ‘adverse events’). You can join in and help spread the word.

‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG).

On 28 August 2023, Janssen-Cilag Pty Ltd voluntarily cancelled COVID-19 VACCINE JANSSEN from the Australian Register of Therapeutic Goods (ARTG).

We are starting a new medical device pilot program to support medical device sponsors to comply with their ongoing post-market surveillance responsibilities.

From 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG).

We are aware that a small number of people have received calls from scammers impersonating the TGA.