Mid-June Launch For EMA’s Simplified Online Orphan Designation Filing System
The European Medicines Agency will encourage companies to submit their orphan designation applications through a new portal when it is launched on June 15. Applications through existing processes will be accepted until Sept. 15.
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The new portal is expected to provide an improved method for applying for and managing EU orphan drug designations.
The European Medicines Agency is developing a new, simplified online system for receiving and managing orphan drug designation applications. Three prospective sponsors have volunteered to test the new system, which is scheduled to go live in early summer.
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.