Covid-19 Response
The Australian Therapeutics Goods Administration expedites assessments of COVID-19 diagnostic kits.
Australia's Therapeutic Goods Administration (TGA) has created a number of new regulations to accelerate the production and supply of COVID-19 test kits, through an expedited assessment procedure.
In some cases, for example point of care tests, due to limited information at the time of application, regulatory approval is granted, with strict conditions that follow-up data and studies including stability shelf-life is provided to the TGA. In addition, a number of exemptions for complying with…