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ICH(The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)
ICH E2D(R1) Draft Guideline- Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
ICH(The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)
ICH E2D(R1) Draft Guideline- Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
【Update Date:
2024-02-21
】
unit:藥品組
Title: ICH E2D(R1) Draft Guideline- Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
Comment Period: To 31 May 2023
Related LInkes:
1.E2D(R1) Draft Guideline: https://ich.org/page/efficacy-guidelines
2.ICH Public Consultations: https://ich.org/page/public-consultations
For more details, please contact: +886-2-27877674
Files
ICH_E2D(R1)_Draft Guideline
E2D(R1) Draft Guideline意見彙整表