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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.
Information on applications for orphan drug status can be found in the Applications for orphan drug designation. The quality, efficacy and safety of orphan drugs are assessed at the same standard as for other registered medicines.Drugs designated as orphan drugs by the TGA are shown in the table below.esignated orphan drugs are eligible for a waiver of their application and evaluation fees, but only if designation is received prior to submitting an application to register an orphan drug on the Australian Register of Therapeutic Goods (ARTG) .