Regulations for Registration of Medicinal Products Article 57
The following documents are required for changes of drug testing specifications, methods and product appearance:1.Application form for post-approval changes;2.Photocopy of drug license (front and back sides);3.Two copies each of the testing specifications, methods and certificate of analysis of changed drugs, and an explanation of the differences in specifications before and after the changes;4.For imported drugs, a notification letter of post-approval changes issued by the original manufacturer.If the changes of testing specifications and methods are according to the update on pharmacopoeias, then the application form should include details of the cited pharmacopoeias, including the title, publication year and edition. The cited pharmacopoeias are restricted to Chinese Pharmacopoeia and pharmacopoeias published in the A10 countries or acknowledged by the central health competent authority and should be the latest edition from the date of application.If the change does not involve the testing items and testing methods, the submission of documents mentioned in Item 3 of the previous paragraph can then be exempt. However, manufacturers should retain all original data and figures for future inspection.
中文原文 藥品查驗登記審查準則第57條
申請藥品檢驗規格、方法、外觀變更登記，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、變更後之藥品檢驗規格、方法及檢驗成績書各二份，並說明新舊二規格之差異。
四、如係輸入藥品，應另附原廠變更通知函。
藥品之檢驗規格、方法依據藥典版次變更者，應於變更登記申請書中記明所依據藥典之名稱、年次及版次；其藥典並以中華藥典、十大醫藥先進國家出版之藥典或其他經中央衛生主管機關同意採為依據之藥典為限，其版本應為其所依據藥典之最新版。
前項變更，不涉及變更檢驗項目及檢驗方法者，免附第一項第三款資料。
但詳細資料及原始數據應留廠商備查。
一、藥品變更登記申請書。
二、藥品許可證正、反面影本。
三、變更後之藥品檢驗規格、方法及檢驗成績書各二份，並說明新舊二規格之差異。
四、如係輸入藥品，應另附原廠變更通知函。
藥品之檢驗規格、方法依據藥典版次變更者，應於變更登記申請書中記明所依據藥典之名稱、年次及版次；其藥典並以中華藥典、十大醫藥先進國家出版之藥典或其他經中央衛生主管機關同意採為依據之藥典為限，其版本應為其所依據藥典之最新版。
前項變更，不涉及變更檢驗項目及檢驗方法者，免附第一項第三款資料。
但詳細資料及原始數據應留廠商備查。