Articles

The COVID-19 pandemic post-market review of facemasks is now finished.

Find out about changes to choline salicylate access, starting from October 2023.

Find out how Product Information inserts won’t be required in the packaging of injectable medicines, given by health professionals, starting from September 2023.

Companies supplying medicines in Australia will be required to provide additional information if their products go into shortage.

Read about our import, advertising and supply compliance priorities for 2023-24.

If you're a sponsor, it's important to be aware of the global issue of nitrosamine impurities in medicines. Find out what steps you should take.

The Government has agreed that regulatory amendments should be drafted to extend the transition arrangements for certain medical device reforms to 1 July 2029.

Stay updated about the commencement of MDMA and psilocybin for the treatment of certain mental illnesses.

To help sponsors and manufacturers transition to new manufacturer evidence.

These international recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, are part of a new international recognition framework for medicines that is specific to the UK following their exit from the European Union.

The TGA has approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’.

Transition period for accepting ISO 13485 ends 26 May 2023.

The Prescribing Medicines in Pregnancy database has now been updated.

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).

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).

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.

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.

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.

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