2022.01.09 GDP関連 Good Distribution Practice For Medicinal Products For Human Use, Questions And Answers, Version 1.0(対訳)
2021.06.02 CSA General Principles of Software Validation; Final Guidance for Industry and FDA Staff 対訳表
QMSR 2022.08.16 【translation into Japanese】FDA Part 820 QMSR(Quality Management System Regulation)revised plan