Coronavirus Notebook: EU Moots Emergency Use Authorization Scheme For Vaccines, Janssen Product Up For 11 March Approval
Celltrion’s regdanvimab is undergoing an emergency use procedure in Europe, the European Medicines Agency and the health authorities in Canada have jointly published clinical data on the Moderna vaccine, and Canada has approved two versions of the AstraZeneca/Oxford University jab.
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Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.
After preliminary discussions with its pandemic task force, the European Medicines Agency has begun reviewing GSK/Vir Biotechnology’s promising COVID-19 treatment to help EU national competent authorities make evidence-based decisions on its possible early use.
Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.