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Medicines Safety Update - Information for health professionals

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

Medicines Safety Update - Information for health professionals

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.

Medicines Safety Update - Information for health professionals

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.

Understand the Medicines Safety Update for July 2023 - Information for health professionals and consumers.

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.

Understand the Medicines Safety Update for June 2023 - Information for health professionals and consumers.

To help sponsors and manufacturers transition to new manufacturer evidence.

Medicines Safety Update - Information for health professionals

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.

A warning about anticoagulant-related nephropathy (ARN) has been added to the Product Information (PI) for all oral anticoagulants.

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.

New warnings for baricitinib, tofacitinib and upadacitinib follow a TGA review of a randomised safety trial called the ORAL Surveillance Study.