Three Sponsors To Test EMA’s New Online Orphan Designation System

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.

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EMA's New Orphan Designation System Will Be Accessible On Various Devices • Source: Shutterstock

The European Medicines Agency is on track to adopt a new web-based system and improvements to the processes of designating orphan drugs by early summer.

The online system is expected to make it easier for companies to apply for a medicinal product to be designated as an orphan drug, and for the EMA to manage...

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