ZAMRA APPROVES 5 COVID-19 VACCINES FOR ZAMBIA zambiareports.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from zambiareports.com Daily Mail and Mail on Sunday newspapers.
EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
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The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
The European Medicines Agency (EMA) uses rolling reviews to speed up the assessment of a promising medicine during a public health emergency, such as the COVID-19 pandemic. Under the typical application process for marketing authorisation, all data on a medicine or vaccine’s effectiveness, safety and quality, as well as all required documents must be ready at the start of the evaluation. In the case of a rolling review, EMA’s Committee for Medicinal Products for Human Use (CHMP) reviews data as they become available from ongoing studies. Once it decides that sufficient data are available, the company can submit a formal application. This shortens the approval timeframe.
PM: India to provide Bahamas with small amount of AstraZeneca vaccine thenassauguardian.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thenassauguardian.com Daily Mail and Mail on Sunday newspapers.