Prevention of Rare Diseases and Orphan Drug Act Article 22
When there are difficulties in manufacturing or importing non-orphan drugs under the provisions of the Pharmaceutical Affairs Act, and said drugs are reviewed by the Review Committee and determined to be beneficial for the treatment of specific diseases, provisions in this Act regarding registration, market approval, and ad hoc application may be applied.
中文原文 罕見疾病防治及藥物法第22條
非罕見疾病藥物依藥事法規定製造或輸入我國確有困難，且經審議會審議認定有助於特定疾病之醫療者，準用本法有關查驗登記及專案申請之規定。