24 November 2021
A list of self-tests that are approved in Australia
3 November 2021
The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.
20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
25 August 2021
Find out information about the different types of tests and how the TGA assesses them and monitors their performance.
24 March 2021
Information about the post-market review of all approved COVID-19 tests and a post-market evaluation of all approved serology-based COVID point-of-care tests.
11 March 2021
In response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
26 August 2020
Dental board practitioners who are registered specialists in oral medicine have now been added to the list of specialist health practitioners who are permitted to initiate treatment using hydroxychloroquine
8 May 2020
Consumers should be alert to misleading claims made online about Miracle Mineral Solution (MMS). The TGA has not approved MMS for use to treat, cure, prevent or alleviate any disease or condition.
7 May 2020
The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits.