Regulations of Bioavailability and Bioequivalence Studies Article 5
Application fees for applying any protocols and reports following the Regulation should be paid, and the completed application forms together with all required dossiers should be submitted to the central health competent authority for assessment.The above-mentioned application forms and documents include the form of bioavailability study protocol, the form of bioequivalence study protocol, the form of bioavailability study report, the form of bioequivalence study report, the form of dissolution profile comparison report, and/or other forms and documents in relation to the application procedure.
中文原文 藥品生體可用率及生體相等性試驗作業準則第5條
依本準則申請核定各種試驗之計畫與報告，應繳納費用，並填具中央衛生主管機關所定之申請書表，依書表所載事項備齊相關資料，送交中央衛生主管機關審核。
前項所稱之申請書表，包括藥品生體可用率試驗計畫書申請表、藥品生體相等性試驗計畫書申請表、藥品生體可用率試驗報告書申請表、藥品生體相等性試驗報告書申請表、溶離率曲線比對報告申請表及其他與申請程序有關之書表格式。
前項所稱之申請書表，包括藥品生體可用率試驗計畫書申請表、藥品生體相等性試驗計畫書申請表、藥品生體可用率試驗報告書申請表、藥品生體相等性試驗報告書申請表、溶離率曲線比對報告申請表及其他與申請程序有關之書表格式。