TGA sets path for RATs

COVID 19 rapid antigen tests (RATs) will be available for home use by Australians from 01 Nov under a plan released by the Therapeutic Goods Administration (TGA) today.

Under the TGA’s timeframe, the agency will issue a new regulation by 01 Oct that will enable companies to formally apply for regulatory approval to legally supply RATs for home use.

“This is an important step in supporting the National Plan to transition Australia’s National COVID-19 Response and aligns with the timeframe where it is expected that approximately 70% of Australians will be double vaccinated,” the TGA said.

“Individual tests will require TGA approval and inclusion in the Australian Register of Therapeutic Goods (ARTG) as it is for all other testing kits.

“The TGA has already commenced the review of data and information for self-tests for those suppliers who have responded to the registration of interest process.

“The use of COVID-19 rapid antigen point-of-care tests is one part of Australia’s strategy to combat COVID-19.”

The TGA confirmed it has been working with suppliers and manufacturers of the tests to ensure instructions are easy to understand for consumers, that appropriate support is available to answer users’ questions and that the tests “perform satisfactorily against variants such as Delta”.

Federal Health Minister, Greg Hunt, said further rules about the use of RATs for home testing would be set by State and Territory governments.

The Pharmaceutical Society of Australia (PSA) has previously backed the use of RATs to help pharmacies that have been linked to a positive COVID-19 case, to keep their doors open.

Earlier this month, PSA CEO, Mark Kinsela called for RATs to be funded for pharmacy workers (PD 17 Sep).