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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.

21 May 2021
The TGA granted a provisional determination to GlaxoSmithKline Australia Pty Ltd in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14 April 2021
12 May 2021
The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years of age or older.
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.
16 February 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine
9 February 2021

The plan outlines five key strategies to strengthen Australia's vaccine vigilance system.

9 February 2021
A comprehensive system is in place to capture reports of adverse events following COVID-19 vaccination.
9 February 2021

Access the COVID-19 vaccine weekly safety report, and learn how the TGA continues to monitor the safety of vaccines so that we can detect and respond to any safety concerns

8 February 2021
Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA)
2 February 2021
The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.

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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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