Articles

Information about the TGA's safety monitoring of COVID-19 vaccines.

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

We have issued infringement notices to the company Naturally Elevated Pty Ltd and an individual for the alleged unlawful advertising of medicinal cannabis on websites and social media pages.

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.

This instrument is made under subregulation 10JD(4) of the Therapeutic Goods Regulations 1990.

Information about the TGA's safety monitoring of COVID-19 vaccines.

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.

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

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

Medicines Safety Update - Information for health professionals

On 29 August 2023, the TGA executed multiple warrants on storage units and residences in Brisbane and seized over 40,000 vaping products with an estimated street value of over $1.2 million

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

We have issued infringement notices for $26,640 to Nius Development Pty Ltd for the alleged unlawful import of unapproved cosmetic injectable products.

The TGA has issued 7 infringement notices totalling $115,500 to the company for the alleged unlawful advertising and supply of sport supplement products containing banned substances.

Information about the TGA's safety monitoring of COVID-19 vaccines.

To help sponsors and manufacturers transition to new manufacturer evidence.

Transition period for accepting ISO 13485 ends 26 May 2023.

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

Find out how listed medicine ingredients, and requirements for their use, have been updated in the latest Therapeutic Goods (Permissible Ingredients) Determination.

The TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.

Information about the TGA's safety monitoring of COVID-19 vaccines.

TGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.

Information about the TGA's safety monitoring of COVID-19 vaccines.