Page 116 - 2023食品藥物管理署年報(中文版)
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公告日期                     名　稱                                         重點內容
            E14 QT/QTc

     11 25    The Clinical Evaluation of QT/QTc Interval
            Prolongation and Proarrhythmic Potential for
            Non-antiarrhythmic Drugs

     11 28

            ICH E18                                            ICH  2017  ICH E18

     12 6   Guideline on Genomic Sampling and

            Management of Genomic Data

     12 8

            ICH E16:

     12 29                                         Biomarkers                      CTD
            Related to Drug or Biotechnology Product
            Development:Context , Structure and
            Format of Qualification Submissions

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