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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.

24 April 2020
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
19 March 2020
Information for manufacturers of therapeutic goods about the suspension of all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality Management System) audits

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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