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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.

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18 December 2020
The TGA is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods to ensure the quality and effectiveness of face masks.
10 December 2020
If you are considering supplying face masks (including respirators) that meet the definition of a medical device in Australia, you will need to apply for the inclusion of these products in the ARTG.
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.
4 December 2020
The Access Consortium regulatory authorities have pledged their collective support in countering the COVID-19 global pandemic
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
2 December 2020
The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.
2 December 2020
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.
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.

27 November 2020

Find information and guidance about the regulatory requirements and processes.

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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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