Faster Submissions For Orphan Designation Possible As EMA’s Online Portal Goes Live
The new portal is expected to provide an improved method for applying for and managing EU orphan drug designations.
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The European Medicines Agency says progress is being made with new IT systems for clinical trial and orphan designation applications in the EU.
The European Medicines Agency says that its IRIS portal will reduce the time needed for parallel distributors to prepare and submit notifications.
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.