Regulations of Bioavailability and Bioequivalence Studies Article 24
Applicants shall voluntarily or commission an agency who implements bioavailability and bioequivalence studies save samples of drugs (including test and reference products). Sufficient samples should be retained for at least five years after report is approved. Applicants should cooperate with the competent health authorities for retest and inspection. Applicant should do likewise even the study report has not been approved.
中文原文 藥品生體可用率及生體相等性試驗作業準則第24條
申請人應自行或委由試驗執行機構保存執行生體可用率及生體相等性試驗之藥品（含受試藥品及對照藥品），且足夠留樣至報告核准後至少五年，並配合衛生主管機關覆驗、查核。
試驗報告未獲核准者，亦同。
試驗報告未獲核准者，亦同。