Australia – Australia to permit some self-test IVDs after industry calls for change

The Therapeutic Goods Administration (TGA) is set to allow the sale of a limited range of self-test in vitro diagnostics (IVDs) in Australia. TGA proposed the regulatory change after GlaxoSmithKline and other organizations used a consultation to voice their dissatisfaction with the current system.

Home-use tests for serious diseases have been banned in Australia for the past decade. TGA made an exception for HIV tests in 2014 but has otherwise maintained the position adopted in 2020. With the 2010 law up for a mandatory review this year, TGA began a consultation 10 months ago to learn if there is an appetite for expanding self-testing beyond HIV.

TGA emerged from the consultation with plans to allow the sale of home-use tests in 11 therapeutic areas. Most of the therapeutic areas are different infectious diseases, with HIV joined by pathogens including seasonal influenza, hepatitis C and neisseria gonorrhoea on the list of bacteria and viruses eligible for self-tests. TGA will also permit at-home tests of some chronic conditions, namely diabetes and cardiovascular and kidney disease…