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Coronavirus (COVID-19): Information on medicines and medical devices

The TGA is publishing the latest information about medicines and medical devices as it relates to COVID-19 on this page.

Please read the information below before contacting the TGA to see if your question is already answered.

28 April 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
24 March 2021
In response to the COVID-19 pandemic, the TGA has expedited approvals for inclusion of COVID-19 tests in the Australian Register of Therapeutic Goods (ARTG). The TGA has commenced validation reviews of serology-based COVID-19 point-of-care tests included in the ARTG.
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.
9 March 2021
Due to the unprecedented pressures COVID-19 has placed on the pharmaceutical industry, sponsors of listed medicines and registered over-the-counter (OTC) and complementary medicines (RCM) are eligible to request consent not to comply with TGO 92 labelling requirements for a limited time.
19 February 2021

This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections

13 January 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.
4 December 2020
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
3 August 2020
Information on advertising of products related to COVID-19, GMP information for sponsors and manufacturers and access to coronavirus tests, medicines and vaccines, including medicine shortages
10 July 2020
The TGA has granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19.

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Department of Health

Coronavirus (COVID-19) health alert — for information and advice not specific to therapeutic goods.

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