Saudi Cultural Missions Theses & Dissertations

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Review times and clinical evidence on COVID-19 Vaccine Approvals in the US Food and Drug Administration and European Union” EMA”
(Massachusetts University, 2024) Abu Rukbah, Walaa Saad; Mekary, Rania
Background: Medication approval procedures have undergone streamlining by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This study identifies discrepancies in evidence supplied, comparing the review times and regulations of drugs licensed by both agencies. Objective: To compare the alignment of review outcomes between the EMA and FDA for medicines approved by both agencies from 2020 to 2022. Design: By examining the FDA and EMA websites, all COVID-19 vaccines licensed from December 2020 to January 2022 were identified. Publicly available information from the FDA and EMA websites determined the COVID-19 vaccines approved by each agency. Results: In 2020-2022, the FDA licensed 3 vaccines, while the EMA licensed 5. The median review time is typically shorter in the FDA than in the EMA. Differences in regulations and processes for COVID-19 vaccines submitted to the two regulators were identified. Conclusion: The median review time for COVID-19 vaccines approved by both agencies was similar. Despite differences in regulations and processes due to the pandemic, both the FDA and EMA share the common goal of ensuring safety and efficacy.
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