Regulations for Registration of Medicinal Products Article 22-2
For drugs other than the categories listed in the preceding article, whether an application of a bridging study assessment shall be filed is left to the discretion of manufacturers. For applications without bridging study data, if the central health competent authority considers that a bridging study is necessary, the manufacturer is obliged to conduct a bridging study.
中文原文 藥品查驗登記審查準則第22-2條
非屬前條應申請銜接性試驗評估之藥品，得自行決定是否申請該試驗評估；其決定不申請而逕辦理查驗登記，經中央衛生主管機關審查認有必要者，仍應執行銜接性試驗。