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EMA Updates Guidelines on Submitting Requests for Orphan Status
Drugs Regulatory Affairs
The European Medicines Agency (EMA) on Monday issued updated guidelines for the agency’s orphan designation submission process.
Sponsors will no longer be required to send a notification that they intend to file for orphan status ahead of their submission. But the agency strongly encourages they request a pre-submission meeting at least two months before the planned submission date.
The EMA launched its secure online portal for management and submission of orphan designations in June. Filing through the portal will become mandatory on Sept. 19.