European Medicines Agency simplifies processing of fee reductions for orphan medicines

The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. This forms part of the EMA's effort to reduce administrative burden for applicants and streamline the procedures for fee reductions.

Medicines that have been granted orphan designation by the European Commission on the recommendation of the EMA’s Committee for Orphan Medicinal Products (COMP) are eligible for fee reductions for a range of regulatory activities. These include pre-authorization activities such as protocol assistance, the application for marketing authorization and inspections.

The Agency now needs no additional information from the sponsor before submitting an application eligible for fee reduction for orphan medicines.