Regulations for Registration of Medicinal Products Article 52
The change of dosage form is restricted to changes among tablets, sugar-coated tablets and film-coated tablets; between cream and ointment or among gel, cream and ointment for external use provided that drugs with identical ingredients, dosage form and dose have been approved by the central health competent authority.The following documents are required for the change of dosage forms:1.Application form for post-approval changes;2.The original copy of drug license;3.Manufacturing and Control Standard, or the batch records of the same lot as the finished products;4.Stability study results;5.For locally manufactured drugs, the testing specifications, methods and certificate of analysis of the finished products, as well as the assurance statement (A) and supporting documents of factory registration;6.For imported drugs, the testing specifications, methods and certificate of analysis of the finished products and active substances used for the batch, as well as a notification letter of post-approval changes issued by the original manufacturer and the CPP issued by the country of origin are needed.
中文原文 藥品查驗登記審查準則第52條
藥品劑型之變更，以錠劑、糖衣錠、膜衣錠之間或乳膏劑、軟膏劑之間互為變更，或符合中央衛生主管機關曾核准相同有效成分、劑型、劑量之外用凝膠劑與乳膏劑、軟膏劑之間互為變更為限。
申請前項劑型變更登記，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、製造管制標準書，或與成品同批次之製造紀錄。
四、安定性試驗資料。
五、如係國產藥品，應另附成品檢驗規格、方法及成績書、切結書（甲）及工廠登記證明文件。
六、如係輸入藥品，應另附該批次使用之原料與成品檢驗規格、方法及檢驗成績書、原廠變更通知函及出產國許可製售證明。
申請前項劑型變更登記，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、製造管制標準書，或與成品同批次之製造紀錄。
四、安定性試驗資料。
五、如係國產藥品，應另附成品檢驗規格、方法及成績書、切結書（甲）及工廠登記證明文件。
六、如係輸入藥品，應另附該批次使用之原料與成品檢驗規格、方法及檢驗成績書、原廠變更通知函及出產國許可製售證明。