Regulations for Registration of Medicinal Products Article 38
The FSC from the country of origin and the CPP are not required for the application of NCE (New Chemical Entity) drugs.In cases where the FSC from the country of origin and CPP are submitted for the aforementioned application, the central health competent authority may adjust the review process according to the actual situation.For applications of new therapeutic compound, new administration route, new dosage form, new dose or new strength, FSC from the country of origin has to be submitted prior to license acquirement.If the country of origin is a member of the A10 countries, then the submission of the FSC from the country of origin also satisfies the submission of CPP. If the CPP submitted by the applicant states the same manufacturer’s name, address, formulation, dosage form and contents as the information of the new drug in the application, then the submission of CPP also satisfies the requirement of submission of the FSC from the country of origin.
中文原文 藥品查驗登記審查準則第38條
申請新成分新藥查驗登記，得免附出產國許可製售證明及採用證明。
前項申請，如檢附出產國許可製售證明及採用證明者，中央衛生主管機關得視實際情況，調整審查流程。
申請新療效複方、新使用途徑、新劑型、新使用劑量、新單位含量製劑查驗登記，未附出產國許可製售證明者，應於領證前補齊。
出產國許可製售證明如係屬十大醫藥先進國者出具，視為已檢附十大醫藥先進國家中一國之採用證明。
申請者檢送之採用證明，刊載之產品製造廠名稱、地址及處方內容、劑型、含量，與申請之新藥相同者，視為已檢附出產國許可製售證明。
前項申請，如檢附出產國許可製售證明及採用證明者，中央衛生主管機關得視實際情況，調整審查流程。
申請新療效複方、新使用途徑、新劑型、新使用劑量、新單位含量製劑查驗登記，未附出產國許可製售證明者，應於領證前補齊。
出產國許可製售證明如係屬十大醫藥先進國者出具，視為已檢附十大醫藥先進國家中一國之採用證明。
申請者檢送之採用證明，刊載之產品製造廠名稱、地址及處方內容、劑型、含量，與申請之新藥相同者，視為已檢附出產國許可製售證明。