Regulations for Registration of Medicinal Products Article 55
The following documents are required for the changes in drug administration and dosage:1.Application form for post-approval changes;2.Photocopy of drug license (front and back sides);3.Two copies of complete clinical trial report or related references of the claimed drug administration and dosage;4.An original approved copy of the form with labels and package inserts attached along with the central health competent authority’s stamp on the seams. The above-mentioned documents can be exempted when the original copy was approved via the electronic submission platform;5.Two actual packaging materials (or color photos) or drafts of Chinese package inserts, labels, outer boxes, and aluminum blister foil sheets. For imported drugs, two copies of package inserts in the original foreign language are needed;6.A photocopy of official reference books, or certificates claiming drug dosage and administration approved by the central health competent authority and authenticated by the R.O.C. foreign affairs offices is needed. If these documents are not available at the time for filing, the applicant shall provide the required documents before approval. The authentication requirement is waived for documents issued by A10 countries or the EMA. The above-mentioned documents can be replaced with the approval information on the A10 countries highest health competent authority or the EMA’s official website and approval letter of new drug administration and dosage issued by the of A10 countries or the EMA;7.For imported drugs, a notification letter of post-approval changes issued by the original manufacturer;8. The comparison table of changes of package inserts or drafts of package inserts with tracking revisions and comments.
中文原文 藥品查驗登記審查準則第55條
申請藥品用法用量變更登記，應檢附下列資料：
一、藥品變更登記申請書。
二、藥品許可證正、反面影本。
三、所宣稱用法用量之完整臨床試驗報告或相關文獻報告二份。
四、原核准並蓋有中央衛生主管機關騎縫章之外盒、仿單、標籤黏貼表；經線上平台核定者，免附。
五、標籤、中文仿單、外盒、鋁箔片實體或彩色照片或其擬稿各二份；如係輸入藥品，應另附外文仿單二份。
六、公定書影本或經中央衛生主管機關認可之核准用法用量之證明且經我國駐外館處文書驗證；如未能於申請時檢附者，得於中央衛生主管機關核准前補齊該證明及文書驗證。
但為十大醫藥先進國家衛生機關或EMA出具者，得免驗證。
前述證明文件，得以十大醫藥先進國最高衛生主管機關或EMA官方網站核准資訊及該國或EMA核准該用法用量之核准函替代之。
七、如係輸入藥品，應另附原廠變更通知函。
八、仿單變更前後對照表或含追蹤修訂及註解之中文仿單擬稿。
一、藥品變更登記申請書。
二、藥品許可證正、反面影本。
三、所宣稱用法用量之完整臨床試驗報告或相關文獻報告二份。
四、原核准並蓋有中央衛生主管機關騎縫章之外盒、仿單、標籤黏貼表；經線上平台核定者，免附。
五、標籤、中文仿單、外盒、鋁箔片實體或彩色照片或其擬稿各二份；如係輸入藥品，應另附外文仿單二份。
六、公定書影本或經中央衛生主管機關認可之核准用法用量之證明且經我國駐外館處文書驗證；如未能於申請時檢附者，得於中央衛生主管機關核准前補齊該證明及文書驗證。
但為十大醫藥先進國家衛生機關或EMA出具者，得免驗證。
前述證明文件，得以十大醫藥先進國最高衛生主管機關或EMA官方網站核准資訊及該國或EMA核准該用法用量之核准函替代之。
七、如係輸入藥品，應另附原廠變更通知函。
八、仿單變更前後對照表或含追蹤修訂及註解之中文仿單擬稿。