You are here

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.

7 September 2021

Guidance and checklist for businesses to understand the requirements for safe implementation of COVID-19 rapid antigen point-of-care testing.

25 August 2021

Find out information about the different types of tests and how the TGA assesses them and monitors their performance.

25 August 2021
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.
24 August 2021
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
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.
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.
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
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

Pages

Further information

Contact TGA Info

Tel: 1800 020 653
Email: info@tga.gov.au

Note: we are currently experiencing a high volume of calls and emails. Please bear with us as we try to respond to queries as quickly as possible.

Department of Health

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

Follow us