Articles

The TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).

Medicines Safety Update - Information for health professionals

We are conducting surveys to collect information about medical devices manufactured at the point-of-care.

The TGA has approved the first commercially supplied test kit for the detection of Mpox (monkeypox) virus.

Find out about new transition arrangements for dual labelled ingredient names.

Essential Principle 7 now mentions nanomaterials explicitly (see EP 7.7).

Medicines Safety Update - Information for health professionals

From 22 March 2023 changes to the Therapeutic Goods Act 1989 will help alleviate the effects of medicine shortages on patients.

Provisional registration of Tecentriq (atezolizumab) for the treatment in mTNBC will lapse on 22 March 2023.

Health professionals should check if patients undergoing general anaesthesia have used products containing pholcodine in the previous 12 months.

The TGA is aware of concerns about decreased effectiveness of monoclonal antibodies against the COVID-19 caused by emerging SAR-COV-2 variants. At this stage, the regulatory status of the products remain unchanged in Australia.

Medicines Safety Update - Information for health professionals

In response to user feedback, we have been trialling a beta version of the DAEN – medicines since June 2022 alongside the older database.

Supplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time.

Medicines Safety Update - Information for health professionals

New guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.

Medicines Safety Update - Information for health professionals

Current antibiotics shortages in Australia include amoxicillin, amoxicillin/clavulanic acid, cefalexin, metronidazole and trimethoprim.

Medicines Safety Update - Information for health professionals

The Prescribing Medicines in Pregnancy database has now been updated.

The Generic Medicines Work-Sharing Initiative has updated its Operational Procedures document and Expression Of Interest form.

Before you take a weight loss supplement or medicine, there are things to consider.

Medicines Safety Update - Information for health professionals

A warning to social media influencers and advertisers not to advertise this prescription medicine.