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EMA streamlines orphan drug application procedure.
The European Medicines Agency (EMA) has stopped requiring sponsors of orphan drugs to inform EMA of their intention to submit an application to be eligible for a fee reduction. This change is part of EMA’s effort to streamline the procedures for fee reductions and is effective immediately.
Drugs that have been granted orphan designation by the European Commission on the recommendation of the EMA’s Committee for Orphan Medicinal Products are eligible for fee reductions for a range of regulatory activities including pre-authorization activities such as protocol assistance, the application for marketing authorization, and inspections. EMA will no longer require additional information from the sponsor before submitting an application eligible for fee reduction for orphan drugs.
EMA has removed “Procedural Advice on Fee Reductions for Designated Orphan Medicinal Products” from the Agency’s website and the standard operating procedure on processing of fee reductions for designated orphan drug products (SOP/H/3048) is now obsolete.