Regulations for Registration of Medicinal Products Article 38-5
For drugs received designations of treatment of pediatric or rare severe disease from the central health competent authority, CPPs are not required for the application of NCE. If FSC from the country of origin are not available at the time of filing, the applicant shall provide it before approval. If relevant domestic clinical trial data to the claimed indications in Taiwan is provided, the FSC from the country of origin is not required.
中文原文 藥品查驗登記審查準則第38-5條
經中央衛生主管機關認定符合我國小兒或少數嚴重疾病藥品審查認定之藥品，申請新成分新藥查驗登記，免附採用證明；申請人無法於申請時檢附出產國許可製售證明者，應於領取許可證前補齊。
其於我國執行所申請適應症相關臨床試驗者，免附出產國許可製售證明。
其於我國執行所申請適應症相關臨床試驗者，免附出產國許可製售證明。