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An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.n average the cost per patient for orphan drugs is six times that of non-orphan drugs, a clear indication of their pricing power.. Partly as a result of the 1983 US Orphan Drug Act, Japan adopted it in 1993 as did the European Union in 2000.
This section provides guidance and procedural information on applying for orphan designation for medicines for rare diseases in the European Union (EU).It also includes information on what happens after a designation has been granted, including the incentives available for sponsors developing orphan medicines.pplications for orphan designation are examined by the European Medicines Agency's Committee for Orphan Medicinal Products (COMP), using the network of experts that the Committee has built up. The evaluation process takes a maximum of 90 days from validation.