Regulations for Registration of Medicinal Products Article 56
The following documents are required for the change in excipients:1.Application form for post-approval changes;2.If the change in excipients could affect the characteristics of the drug, the applicant should follow the notice issued by the central health competent authority to perform drug testing and to provide two copies each of the testing specifications, methods, and certificate of analysis, as well as one copy each of the safety data, BE test data and stability test data;3.Photocopy of the drug license;4.For imported drugs, a notification letter of post-approval changes issued by the original manufacturer and the CPP from the country of origin.The application of the above-mentioned changes has to comply with Article 46.Whereas the active ingredients, dosage form, dose and administration route of a licensed drug remain unchanged, the appearances or shapes are altered by changing its aromatics, coloring agents or flavours without any pharmacological effects, and do not affect drug quality or medication safety, then it can be justified by applying for post-approval changes for excipients as the addition of new contents. Appropriate descriptions should be given on labels, package inserts and outer packaging for clear differentiation. Graphic designs and colors may be changed to suit the new descriptions.
中文原文 藥品查驗登記審查準則第56條
申請藥品賦形劑變更登記，應檢附下列資料：
一、藥品變更登記申請書。
二、如賦形劑變更足以影響藥品特性者，應依中央衛生主管機關通知，將藥品送驗並附檢驗規格、方法及檢驗成績書各二份、安全性之資料、生體相等性試驗資料及安定性試驗資料。
三、藥品許可證影本。
四、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。
前項變更登記，應符合第四十六條之規定。
如藥品之有效成分、劑型、劑量、用途均相同，其不具任何藥理作用香料、色素、矯味劑之外觀或形狀變更，不影響藥品品質及民眾用藥安全者，得以賦形劑變更方式，檢送資料增加上述組成。
但其藥品標籤、仿單及外盒包裝應有適當文字敘述，以明顯區別，至其圖案、顏色得配合文字敘述有不同組成。
一、藥品變更登記申請書。
二、如賦形劑變更足以影響藥品特性者，應依中央衛生主管機關通知，將藥品送驗並附檢驗規格、方法及檢驗成績書各二份、安全性之資料、生體相等性試驗資料及安定性試驗資料。
三、藥品許可證影本。
四、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。
前項變更登記，應符合第四十六條之規定。
如藥品之有效成分、劑型、劑量、用途均相同，其不具任何藥理作用香料、色素、矯味劑之外觀或形狀變更，不影響藥品品質及民眾用藥安全者，得以賦形劑變更方式，檢送資料增加上述組成。
但其藥品標籤、仿單及外盒包裝應有適當文字敘述，以明顯區別，至其圖案、顏色得配合文字敘述有不同組成。