Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 (English, HTML)

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Publisher-reported update

2020-04-03

COVID-19 is a new disease not previously identified in humans. Currently there is no vaccine or therapeutic product for COVID-19 that is authorized to treat or prevent the disease. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection. In an effort to facilitate earlier access to a vaccine, or therapeutic product for COVID-19, the Department will expedite the review of any COVID-19 related health product submissions and applications. Doing this will ensure timely access to novel therapies without compromising the safety, efficacy and quality of products.

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