Articles

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. 

The Product Information (PI) documents for antidepressants have been updated with warnings about sexual dysfunction continuing in some patients, after they stop using the medicines.

Medicines Safety Update - Information for health professionals

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.

Medicines Safety Update - Information for health professionals

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.

Our investigation into the risk of retinal vasculitis and/or retinal occlusive vasculitis in patients being treated with faricimab (Vabysmo) found that stronger warnings regarding this risk were needed in the Product Information (PI) and Consumer Medicine Information (CMI).

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

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

Medicines Safety Update - Information for health professionals

Medicines Safety Update - Information for health professionals

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January 2024, as part of the reforms to the regulation of vaping products, the Advertising Permission for Nicotine was repealed.

Medicines Safety Update - Information for health professionals

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

Be alert to new warnings of romosozumab (Evenity) cardiovascular risks for patients with a history of heart attack or stroke. If you're a health professional, read our Medicine safety update.

If you're a health professional, get the latest information about medicines with safety related updates to their Product Information.  

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).

Recent coronial inquiries have highlighted the need for health professionals to be alert to the well documented risk of overdose with baclofen.