Regulations for Registration of Medicinal Products Article 38-3
With the approval from the central health competent authority, clinical trials in compliance with the regulations set out in the previous two articles can be qualified for an exemption of, or a substitution for bridging studies.
中文原文 藥品查驗登記審查準則第38-3條
依前二條規定進行之臨床試驗結果，經申請中央衛生主管機關核准者，得免除或替代銜接性試驗。