Regulations of Bioavailability and Bioequivalence Studies Article 11
The selection of reference product in a bioequivalence study should comply with the following rules:1.For drug products with active ingredients under pharmacovigilance (even the pharmacovigilance period has expired), brand product with identification documents or the first approved domestic drug product should be selected.2.For drug products with active ingredients not under pharmacovigilance，the selected reference product should be confirmed with documents that identify following characteristics in preference order:(1)Brand products.(2)An approved domestic drug product with established bioavailability.(3)A drug product that is bioequivalent to the brand product or has been proved as clinically effective.3.The reference products that are specified by the central competent health authority are applicable, excluding the preceding circumstance described previously.For reference product selected according to the preceding Subparagraph 1 and 2(1)., but different in manufacture sites as approved in Taiwan, the applicants should provide with proper supportive data to proof the quality of selected reference product and explain the reason for selection.
中文原文 藥品生體可用率及生體相等性試驗作業準則第11條
選擇執行生體相等性試驗之對照藥品，規定如下：
一、監視新藥成分之對照藥品，應選用有資料證明係原開發廠之產品或中央衛生主管機關核准上市之第一家產品。
二、非監視新藥成分之對照藥品，應選用有資料證明係符合下列情形之一者：
（一）原開發廠之產品。
（二）已知生體可用率之國內市售品。
（三）與原開發廠之產品具生體相等性或證明臨床有效性之產品。
三、除前二款規定之情形外，其他經中央衛生主管機關認可之對照藥品。
依前項第一款及第二款第一目規定選用之對照藥品，如係與我國核准產品同廠牌不同製造廠者，應提供足以佐證對照藥品品質之相關資料，並說明選用之理由。
一、監視新藥成分之對照藥品，應選用有資料證明係原開發廠之產品或中央衛生主管機關核准上市之第一家產品。
二、非監視新藥成分之對照藥品，應選用有資料證明係符合下列情形之一者：
（一）原開發廠之產品。
（二）已知生體可用率之國內市售品。
（三）與原開發廠之產品具生體相等性或證明臨床有效性之產品。
三、除前二款規定之情形外，其他經中央衛生主管機關認可之對照藥品。
依前項第一款及第二款第一目規定選用之對照藥品，如係與我國核准產品同廠牌不同製造廠者，應提供足以佐證對照藥品品質之相關資料，並說明選用之理由。