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ARTICLE · 04 OCTOBER 2021

COVID-19 testing at home: new regulation to allow rapid antigen self-tests

Piper Alderman
Piper Alderman
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A new wave of COVID-19 rapid antigen self-tests, so sponsors must ensure appropriate systems are in place.

AustraliaCoronavirus (COVID-19)
Lis Boyce
Lis Boyce
Samiha Asim
Samiha Asim
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With Australia expected to reach vaccination targets in mere weeks, the Therapeutic Goods Administration is reassessing its position on the supply of COVID-19 rapid antigen self-tests.

Change in regulation to allow supply of self-tests for home use

Aligning with the transition of Australia's national COVID-19 response, the Therapeutic Goods Administration (TGA) announced that they would make a new regulation on 1 October 2021 to allow companies to seek approval to legally supply COVID-19 rapid antigen self-tests for use at home in Australia after 1 November 2021. Currently, the supply of self-tests is prohibited under the Therapeutic Goods (Medical Devices – Excluded Purposes) Specification 2020 (Excluded Purposes Specification) for risk of under-reporting and reliability. However, with the national target of 70% double vaccination approaching quickly, the TGA is undertaking necessary work to allow the supply of self-tests in order to improve accessibility to

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