The Therapeutic Goods Administration (TGA) announced it will make a new regulation (Specification) by 1 October 2021 that will allow companies to formally apply for TGA regulatory approval after 1 October to legally supply their self-tests for use at home in Australia after 1 November 2021.
Individual tests will require TGA approval and inclusion in the Australian Register of Therapeutic Goods (ARTG) as 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 Pharmacy Guild of Australia says rapid antigen self-testing kits will become another tool in the fight to suppress Covid-19 in Australia with National President, Trent Twomey, welcoming the move by the TGA.
Mr Twomey expects that upon approval, test kits would be widely available through community pharmacies across Australia.
“We need to utilise all available resources in this once-in-a-century fight against this pandemic,” says Mr Twomey.
“As the Federal Minister for Health, Greg Hunt, has made clear, all necessary checks and balances must be undertaken to ensure safety and effectiveness of these tests; and also the regulatory process will involve State and Territory Governments.
“Community pharmacists have helped accelerate vaccinations against Covid-19, especially now that Moderna vaccine stocks are available.
“Pharmacists will continue to deliver resources to the community in the fight against Covid and the effort to restore our Australian way of life – at least to a ‘new normal’,” says Mr Twomey said.
The TGA says it will continue to work with suppliers and manufacturers of self-tests to ensure:
- Instructions for use are written in a way that all consumers can understand.
- Suppliers having appropriate support available for example, via a You-tube video, 1800 call number, website fact sheets for consumers to seek help or ask questions.
- Usability testing has been successful with untrained, unsupervised users.
- Self-tests perform satisfactorily against variants such as Delta, noting that many tests in the international market were developed prior to the Delta variant becoming predominant.
The TGA advises that it is important that the appropriate systems are in place, including by State and Territories, to ensure the reliable use of these tests at home occurs at the earliest possible time, including enabling any consumer who has a positive rapid antigen test result is supported to immediately have a confirmatory PCR test at a Covid-19 testing centre.
