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 EMA hopes that the use of a single portal by drug companies and EU/EEA inspectorates to coordinate on good manufacturing practice inspections will drive greater efficiency.
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.