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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.

9 September 2021

COVID-19 vaccines undergoing evaluation for provisional registration by the TGA

8 September 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.
7 September 2021

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

27 August 2021
The Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.
27 August 2021
The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.
27 August 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine
27 August 2021
The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.
25 August 2021
COVID-19 tests must be done under the direction of a health professional. The advertising and sale of home tests is prohibited.
25 August 2021
Information on the three types of COVID-19 tests (nucleic acid/PCR, Rapid antigen and serology antibody tests), including test 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.

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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.

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