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COVID-19 treatments: Treatments undergoing evaluation
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.
|Celltrion Healthcare Australia Pty Ltd||regdanvimab (TBA)||Provisional determination notice|
|Roche Products Pty Ltd||casirivimab + imdevimab (RONAPREVE)||Provisional determination notice|
|Merck Sharp & Dohme (Australia) Pty Ltd||molnupiravir (TBA)||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.