Regulations for Registration of Medicinal Products Article 69
The following documents are required for changes in virus strain for a flu vaccine:1.Application form for post-approval changes;2.Original copy of the drug license;3.Two copies of post-change testing specifications, methods and certificate of analysis of the ingredients, manufacturing processes, raw materials and finished products;4.Drug stability study report. If the stability study report for drugs of the new virus strain is not yet available at the time of application, the applicant can submit the stability study report of the old strain, then submit the report of the new strain when the test is finished;5.Clinical reference in relation to the new virus strain6.The originally approved copy of the form for sticking label and package insert. The above-mentioned documents can be exempted when the original copy was approved via the electronic submission platform;7.Two copies of the draft of labels, package inserts and outer boxes after the changes, and the comparison table of changes of package inserts or drafts of package inserts with tracking revisions and comments.;8.For imported drugs, the notification letter of post-approval changes issued by the original manufacturer and the CPP from the country of origin. The above-mentioned documents can be replaced with the approval letter of new virus strain issued by the of A10 countries or the approval information on the official website of A10 countries highest health competent authority or the EMA and approval letter of new virus strain issued by the A10 countries or the country of origin. If the above mention documents are not available at the time of filing, the applicant shall provide it before approval.
中文原文 藥品查驗登記審查準則第69條
申請流行性感冒疫苗病毒株變更登記，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、變更後藥品之成分、製程、原料與成品檢驗規格、方法及檢驗成績書各二份。
四、藥品安定性試驗報告。
但送件申請時，如變更病毒株後之藥品安定性試驗報告尚未完成者，得先檢附變更前之藥品安定性試驗報告，俟新病毒株藥品安定性試驗報告完成後，送交審查核備。
五、新病毒株之相關臨床文獻資料。
六、中央衛生主管機關原核准之外盒、仿單、標籤黏貼表；經線上平台核定者，免附。
七、變更後藥品之標籤、仿單及外盒彩色擬稿二份，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。
八、如係輸入藥品，應另附原廠變更通知函及出產國許可製售證明。
出產國許可製售證明，得以原產國或十大醫藥先進國家之病毒株變更核准函替代之；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核准函。
一、藥品變更登記申請書。
二、藥品許可證正本。
三、變更後藥品之成分、製程、原料與成品檢驗規格、方法及檢驗成績書各二份。
四、藥品安定性試驗報告。
但送件申請時，如變更病毒株後之藥品安定性試驗報告尚未完成者，得先檢附變更前之藥品安定性試驗報告，俟新病毒株藥品安定性試驗報告完成後，送交審查核備。
五、新病毒株之相關臨床文獻資料。
六、中央衛生主管機關原核准之外盒、仿單、標籤黏貼表；經線上平台核定者，免附。
七、變更後藥品之標籤、仿單及外盒彩色擬稿二份，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。
八、如係輸入藥品，應另附原廠變更通知函及出產國許可製售證明。
出產國許可製售證明，得以原產國或十大醫藥先進國家之病毒株變更核准函替代之；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核准函。