24 August 2021
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
21 August 2021
Update to TGA's conditions and advertising requirements for COVID-19 rapid point-of-care tests.
18 August 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
18 August 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
17 August 2021
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.
9 June 2021
Action in relation to non-compliant face masks will be published on the TGA web site
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.
12 March 2021
In response to the COVID-19 pandemic, the TGA has received a significant number of thermometer applications. This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations.
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.
31 January 2021
A list of ventilators that meet minimum requirements and are permitted to be supplied under the COVID-19 Emergency Exemption.