TGA fast-tracks approval of COVID-19-busting disinfectants
The Therapeutic Goods Administration (TGA) has identified disinfectants as critical in preventing the spread of COVID-19 and as such is fast-tracking disinfectant applications in relation to claims against COVID-19.
The TGA has published amendments to the Standard for Disinfectants and Sanitary Products (TGO 104) to allow listed disinfectants to make validated claims to kill the COVID-19 virus on surfaces. Disinfectants that claim to kill microorganisms — including COVID-19 — must comply with the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 and the TGA instructions for disinfectant testing.
According to the TGA, “COVID-19 is an enveloped virus, which means it has an outer membrane. Enveloped viruses are relatively easy to kill compared to non-enveloped viruses, as the outer layer is easily damaged by most environmental disinfectants, provided the disinfectant is used in accordance with label directions.
“Disinfectants containing ≥70% alcohol, quaternary ammonium or diluted household bleach are suitable for use.”
Whiteley Corporation Chairman Dr Greg Whiteley said, “This is a great example of collaboration in a time of national and international crisis with the COVID-19 pandemic.
“The TGA worked with industry association ACCORD Australasia to negotiate a pragmatic approach that will assist in alleviating public health concerns over the risk of the spread of the virus via hospital and medical surfaces.
“The TGA and ACCORD leadership are to be congratulated on the speedy outcome of this change process which will benefit all of the Australian medical community and the medical manufacturing sector. This new technical arrangement will allow improved certainty around disinfecting surfaces within healthcare settings,” Dr Whiteley said.
The TGA states that sponsors and manufacturers of hard-surface disinfectants — or disinfectants that are medical devices — wishing to make label claims of efficacy against COVID-19 must demonstrate efficacy against the surrogate virus human coronavirus 229E or murine hepatitis virus. Consideration can also be given to products that kill other human or animal coronaviruses.
“We would like to note particular thanks to Adjunct Professor John Skerritt and the entire team inside the TGA, and also to Bronwyn Capanna, Executive Director of ACCORD Australasia and her team at ACCORD, for achieving this outcome” Dr Whiteley said.
“There are continuing negotiations on further improvements around other vital infection-prevention technologies. This collaborative process allows Australians to have increased levels of certainty around the health and hygiene standards within Australian hospitals and healthcare providers.
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