Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 2

The disease prevalence mentioned in Paragraph 1, Article 3 of the Act, refers to the annual prevalence rate calculated by the central competent authority with reference to the information reported in accordance with the regulations of Article 7 of the Act and the medical care data from National Health Insurance. The central competent authority shall review the above-mentioned annual prevalence rate at least once every three years.