Prevention of Rare Diseases and Orphan Drug Act Article 3

The term "rare diseases" as used in this Act shall refer to diseases with prevalence rate lower than the standard announced by the central competent authority; or diseases recognized through review by the Review Committee specified in Article 4 of this Act, and designated and publicly announced by the central competent authority under special circumstances.The term orphan drugs as used in this Act shall refer to drugs with major indications for the prevention, diagnosis and treatment of rare diseases that have been submitted under this Act for application, recognized through review by the Review Committee specified in Article 4, and announced by the central competent authority.The term "special nutritional foods essential for the maintenance of life" as used in this Act shall refer to foods that are primarily suited for providing nutrients to rare disease patients, and have been recognized through review by the Review Committee specified in Article 4 and announced by the central competent authority.