Taiwan promulgated and enacted the “Rare Disease and Orphan Drug Act” in 2000. According to the Act, the term “rare diseases” refers to diseases with prevalence lower than the standard announced by the central government or with special circumstances, and reviewed by the“Review Committee for Rare Diseases and Orphan Drugs” as well as  officially announced by the central government. The prevalence rate of rare diseases in the current public notice is lower than 1 in 10,000.