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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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.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.
The Saudi Food & Drug Authority looks at the number of individual case safety reports (ICSRs) submitted by a company, among other risk-based factors, when drawing up its list for routine pharmacovigilance inspections.