Regulations for Registration of Medicinal Products Article 54
The following documents are required for changes in indications:1.Application form for post-approval changes;2.The original copy of drug license;3.Two copies of complete clinical trial report or related references of the claimed indications;4.For locally manufactured drugs, an official reference book recording the new indications is needed. For imported drugs, approval of new indications issued by the central health competent authority of the country of origin and authenticated by the R.O.C foreign affairs offices is needed. If these documents are not available at the time of 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 indications issued by the of A10 countries or the EMA;5.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;6.Two actual packaging materials (or color photos) or drafts of 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;7.For imported drugs, the notification letter of post-approval changes issued by the original manufacturer is needed.8.The comparison table of changes of package inserts or drafts of package inserts with tracking revisions and comments.If there is evidence from clinical trials conducted in Taiwan to justify that the drug is effective and safe for the new indication, then the first applicant applying for the addition of the new indication can be exempt from the requirement described in Item 4 in the preceding paragraph.The first applicant of the addition of a new indication (including changes of indications and addition of indications) may decide whether or not to conduct local clinical trials. If a local clinical trial has been conducted by the first applicant to justify the drug is effective and safe for the new indication, then during the following 5 years, other applications filed by other manufacturers of drugs with the same ingredients, dosage form and dose, either for licensing the new indication or for extending an existing license, should also provide local clinical trial reports up to the standard conducted by the first successful applicant in addition to all the required documents set out in Paragraph 1 Item 1, 2 and 5-7.If the first successful applicant of a new indication (including changes of indications and addition of indications) did not conduct local clinical trials; or the approval was issued more than 5 years ago, then any other applications of drugs with the same ingredients, dosage form and dose, either for licensing the new indication or for adding the new indication to an existing license, should provide all the required documents set out in Paragraph 1 Item 1, 2 and 5-7.If labels and package inserts are revised according to the indications announced by the central health competent authority, the license holder should submit the application form for post-approval changes and the original copy of drug license when applying for post-approval changes of indications.
中文原文 藥品查驗登記審查準則第54條
申請藥品適應症變更登記，應檢附下列資料：
一、藥品變更登記申請書。
二、藥品許可證正本。
三、所宣稱適應症之完整臨床試驗報告或相關文獻報告二份。
四、如係國產藥品，應另附含其新適應症之公定書依據。
如係輸入藥品，應另附經中央衛生主管機關認可國家所核准該適應症之證明，該證明並應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核准該適應症之核准函替代之。
五、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。
六、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。
七、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。
如首家申請增加新適應症之廠商於國內執行臨床試驗並所附資料能證實該新適應症之療效及安全性者，得免附前項第四款資料。
首家申請增加新適應症（含變更適應症及新增適應症）之廠商，得自行決定是否執行國內臨床試驗。
如有執行國內臨床試驗並所附資料能證實該新適應症之療效及安全性者，自其獲准增加新適應症之日起五年內，其他申請相同成分、劑型、劑量許可證之查驗登記宣稱具有該適應症、或已有相同成分、劑型、劑量許可證申請增加該適應症之廠商，應依第一項第一款、第二款及第五款至第七款規定檢附資料，並應另附與首家廠商相同標準之國內臨床試驗報告。
如首家獲准增加新適應症（含變更適應症及新增適應症）之廠商未執行國內臨床試驗或雖有執行國內臨床試驗但其獲准增加新適應症之日已逾五年者，其他申請相同成分、劑型、劑量許可證之查驗登記宣稱具有該適應症或已有相同成分、劑型、劑量許可證申請增加該適應症之廠商，應依第一項一款、第二款及第五款至第七款規定檢附資料。
依中央衛生主管機關公告之統一適應症而自行修訂標仿單者，於申請適應症變更登記時，應檢附藥品變更登記申請書及藥品許可證正本。
一、藥品變更登記申請書。
二、藥品許可證正本。
三、所宣稱適應症之完整臨床試驗報告或相關文獻報告二份。
四、如係國產藥品，應另附含其新適應症之公定書依據。
如係輸入藥品，應另附經中央衛生主管機關認可國家所核准該適應症之證明，該證明並應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核准該適應症之核准函替代之。
五、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。
六、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。
七、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。
如首家申請增加新適應症之廠商於國內執行臨床試驗並所附資料能證實該新適應症之療效及安全性者，得免附前項第四款資料。
首家申請增加新適應症（含變更適應症及新增適應症）之廠商，得自行決定是否執行國內臨床試驗。
如有執行國內臨床試驗並所附資料能證實該新適應症之療效及安全性者，自其獲准增加新適應症之日起五年內，其他申請相同成分、劑型、劑量許可證之查驗登記宣稱具有該適應症、或已有相同成分、劑型、劑量許可證申請增加該適應症之廠商，應依第一項第一款、第二款及第五款至第七款規定檢附資料，並應另附與首家廠商相同標準之國內臨床試驗報告。
如首家獲准增加新適應症（含變更適應症及新增適應症）之廠商未執行國內臨床試驗或雖有執行國內臨床試驗但其獲准增加新適應症之日已逾五年者，其他申請相同成分、劑型、劑量許可證之查驗登記宣稱具有該適應症或已有相同成分、劑型、劑量許可證申請增加該適應症之廠商，應依第一項一款、第二款及第五款至第七款規定檢附資料。
依中央衛生主管機關公告之統一適應症而自行修訂標仿單者，於申請適應症變更登記時，應檢附藥品變更登記申請書及藥品許可證正本。