Regulations for Registration of Medicinal Products Article 18
The information given in the data field of indications on the application form should be based on the drug efficacy or indications approved by the central health competent authority, including the drug re-categorization, drug re-evaluation results, and the Guidelines on the Review of Instruction Drugs.When filling in the information of drug efficacy and indications, in addition to following the regulations stated in the preceding paragraph, the applicant can also provide a summary by taking references from information on new drugs and new indications and formularies of the A10 countries. If there are any changes in efficacy, related information should be provided for review.
中文原文 藥品查驗登記審查準則第18條
申請書之適應症欄，其記載應以中央衛生主管機關核定之藥品效能或適應症品目資料為準，包括藥品再分類品項、藥品再評估結果、指示藥品審查基準。
藥品效能或適應症除依前項規定填明外，申請人得另參考新藥新適應症及十大醫藥先進國家之醫藥品集，簡明填寫。
如療效有所增減，並應檢附有關資料以供審核。
藥品效能或適應症除依前項規定填明外，申請人得另參考新藥新適應症及十大醫藥先進國家之醫藥品集，簡明填寫。
如療效有所增減，並應檢附有關資料以供審核。