Australia Speeds Approvals for COVID-19 Diagnostics
Australia’s Therapeutic Goods Administration has fast-tracked the approval of new rapid tests for COVID-19, with 500,000 tests expected to become available in the county by March 31.
The agency has issued an emergency exemption that allows pathology laboratories to supply their own tests without requiring the tests to be included on the Australian Register of Therapeutic Goods (ARTG).
At the same time, the TGA is expediting reviews for other COVID-19 tests and is working with in-vitro diagnostics suppliers to ensure that tests can accurately detect COVID-19 infections.
The emergency exemption does not allow for general supply of rapid tests other than to the accredited pathology labs specified.