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Home » EMA Guidance Sets Out Criteria, Process for Requesting Orphan Drug Designation
EMA Guidance Sets Out Criteria, Process for Requesting Orphan Drug Designation
Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the rare disease, the scope of the application, the drug’s active substance and mode of action and supporting clinical and nonclinical data.