Before any COVID-19 treatment is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA), part of the Department of Health.
| Sponsor | Name | Further information | Regulatory status |
|---|---|---|---|
| Adjutor Healthcare Pty Ltd | Sabizabulin | Provisional determination notice | Application for provisional registration withdrawn 10 May 2023 |
| AstraZeneca Pty Ltd | tixagevimab and cilgavimab (EVUSHELD) | Provisional determination notice | Product voluntarily withdrawn by sponsor on 15 July 2024 |
| AstraZeneca Pty Ltd | sipavibart | NA | Priority review determination granted 2 August 2024 for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments. |
| Pfizer Australia | nirmatrelvir + ritonavir (PAXLOVID) | Provisional determination notice |
|
| Roche Products Pty Ltd | tocilizumab (ACTEMRA) | Provisional determination notice | Provisionally approved on 1 December 2021 |
| Celltrion Healthcare Australia Pty Ltd | regdanvimab (REGKIRONA) | Provisional determination notice | Provisionally approved on 6 December 2021 |
| Roche Products Pty Ltd | casirivimab + imdevimab (RONAPREVE) | Provisional determination notice | Provisionally approved on 15 October 2021 |
| Merck Sharp and Dohme (Australia) Pty Ltd | molnupiravir (LAGEVRIO) | Provisional determination notice | Provisionally approved on 18 January 2022 |
| GlaxoSmithKline Australia Pty Ltd | sotrovimab (XEVUDY) | Provisional determination notice | Product voluntarily withdrawn by sponsor 9 September 2024 |
| Gilead Sciences Pty Ltd | remdesivir (VEKLURY) | Provisional determination notice |
|
All COVID-19 treatment applications are being treated with the greatest priority as part of the Department of Health's response to the pandemic. Under normal circumstances, the TGA's assessment (for both provisional and general registration) begins once all information to support registration is available. For COVID-19 treatments, the TGA has agreed to accept rolling data to enable early evaluation of data as it comes to hand.
Many of the large-scale clinical trials that will provide evidence of safety and effectiveness are still progressing and these results will be provided to the TGA as they become available. The TGA will also evaluate quality data (such as how the treatments are manufactured).
The TGA will only be in a position to make a provisional registration decision for a treatment once all required data relating to safety, quality and efficacy has been provided and assessed.
With rolling submissions, collaboration with international regulators, and proactively working with sponsors, it is expected the evaluation of COVID-19 treatments will be significantly expedited without compromising on our strict standards of safety, quality and efficacy. However, the timeframe for the evaluation of each treatment will ultimately depend on when the complete data package is provided by sponsors.