New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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The European Medicines Agency is this week considering applications from two companies seeking the coveted accelerated assessment review pathway for their new products.
In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.