Prevention of Rare Diseases and Orphan Drug Act Article 15
When drugs have primary indications for preventing, diagnosing, and treating rare diseases, applications may be submitted for registration and market approval as orphan drugs.Required documents, review procedures and criteria to be used in processing applications for registration and market approval as stated in the preceding Paragraph shall be determined by the central competent authority.
中文原文 罕見疾病防治及藥物法第15條
主要適應症用於預防、診斷或治療罕見疾病者，得申請查驗登記為罕見疾病藥物。
前項申請查驗登記應備之書證資料、審查程序及相關事項之準則，由中央主管機關定之。
前項申請查驗登記應備之書證資料、審查程序及相關事項之準則，由中央主管機關定之。