ICH指导原则共180条
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与药物或生物技术产品相关的生物标记物研发_申请资料的内容、结构和格式
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The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions
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The Common Technical Document for the Registration of Pharmaceuticals for human Use_ Safety
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The Common Technical Document for the Registation of Pharmaceuticals for Human Use_ Quality
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The Clinical Evaluation of QT_QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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Studies in Support of Special Populations_ Geriatrics
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Structure and Content of Clinical Study Reports
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Statistical Principles for Clinical Trials
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Revision of M4e Guideline on Enhancing the Format and Structure of Benefit-risk Information in Ich
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Questions & Answers_ The Clinical Evaluation of QT_QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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Questions & Answers_ Studies in Support of Special Populations _ Geriatrics
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Questions & Answers_ Structure and Content of Clinical Study Reports
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Questions & Answers_ Periodic Benefit-Risk Evaluation Report
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Questions & Answers_ Ethnic Factors in the Acceptability of Foreign Clinical Data
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Principles for Clinical Evaluation of New Antihypertensive Drugs
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Post-Approval Safety Data Management_ Definitions and Standards for Expedited Reporting
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Pharmacovigilance Planning
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Periodic Benefit-Risk Evaluation Report
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Organisation of the Common Technical Document For The Registration of Pharmaceuticals for human use