Regulations of Bioavailability and Bioequivalence Studies Article 25
Any approved study protocol and report cannot be modified, unless modification is approved by the competent health authorities.
中文原文 藥品生體可用率及生體相等性試驗作業準則第25條
經核准之各種試驗計畫與報告，非經中央衛生主管機關同意，不得變更。