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EMA Unveils Online Portal for Orphan Drug Designations
Drugs Regulatory Affairs
The European Medicines Agency launched its new online portal for orphan designation applications and is strongly encouraging companies to start using the portal right away, although it will not fully replace the existing submission process until the fall.
The portal, known as Iris, allows applicants to submit and manage information and documents related to orphan designation applications and it can be used for requesting a pre-submission meeting, tracking an application’s progress and responding to EMA requests for additional information.
It can also be used to view historic applications, to request appeals, to modify sponsor information and to remove or transfer an orphan designation to a new sponsor.