Regulatory Update

| 01 April 2010

FDA and the European Medicines Agency recently agreed to accept the submission of a single annual report from sponsors of orphan drug and biologic products. The single annual report submission to both regulatory agencies is voluntary and will apply only to sponsors who have obtained an orphan designation status for their product from both FDA and the European Medicines Agency. Starting 28 February 2010, sponsors are allowed to send the single Orphan Drug Designation Annual Report to both agencies.


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