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SK Bioscience has applied for CMA of SKY Covione

By Kim, Jin-Gu | translator Kang, Shin-Kook

22.08.02 06:00:34

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Full-scale global certification and plan to apply for permission to EMA, etc



SK Bioscience announced on the 29th that it has applied for Conditional Marketing Authorization (CMA) of the COVID-19 vaccine to MHRA, a British pharmaceutical regulator. The product name in the UK and Europe is SKY Covione. SK Bioscience explained that it has been conducting a Rolling Review since March to receive prompt approval from MHRA. Rolling Review is a system that quickly evaluates promising vaccines and treatments by submitting efficacy, safety, and quality data sequentially before applying for final permission.

SK Bioscience submitted additional phase 3 clinical data recently secured to MHRA. MHRA will begin a full-fledged review for SKY Covione's CMA. Starting with the UK, SK Bioscience plan

Kim, Jin-Gu(kjg@dailypharm.com)
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