The European Medicines Agency (EMA) has begun a “rolling review” of the AstraZeneca Oxford SARS-CoV-2 vaccine candidate. Normal regulatory processes for medicines involve the submission of all safety and efficacy data to the Agency at the completion of clinical trials. A “rolling review” means that the Agency can begin evaluating data as it becomes available. By employing this method of approval, the regulation process will maintain its usual quality and safety standards, but be shorter than the usual process due to the time gained by reviewing data as it becomes available.
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EMA starts first rolling review of a COVID-19 vaccine in the EU