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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.

4 December 2020
The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance.
2 December 2020
The TGA has received applications and is assessing preliminary data for three COVID-19 vaccines using the provisional pathway and rolling review procedures.
27 November 2020

Understand the regulatory process of how a COVID-19 vaccine application is submitted and assessed before a vaccine is approved for supply in Australia.

18 November 2020
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
18 November 2020
On 16 November 2020 the TGA granted a provisional determination to Janssen in relation to its COVID-19 vaccine, Ad26.COV2.S.
14 October 2020
The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA].
9 October 2020
The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant].
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
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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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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