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编号
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阶段
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发布日期
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内容
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E1 Clinical Safety for Drugs used in Long-Term Treatment （长期用药的临床安全性）
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E1
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Step 5
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1994-10-27
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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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对非危及生命的疾病的长期治疗药物进行临床安全性评估的人群暴露程度
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E2 Pharmacovigilance （药物警戒）
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E2A
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Step 5
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1994-10-27
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Clinical Safety Data Management: Definitions and Standards for Expedited
Reporting
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临床安全性数据管理：快速报告的定义和标准
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E2B(R3)
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Step 5
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2015-4
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Clinical Safety Data Management: Data Elements for Transmission of Individual
Case Safety Reports
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临床安全性数据管理：个体病例安全性报告传递的数据要素
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E2B(R3) IWG
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Step 5
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2016-6-16
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Implementation: Electronic Transmission of Individual Case Safety Reports
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关于E2B(R3)实施的问与答
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E2C(R2)
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Step 5
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2012-12-17
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Periodic Benefit-Risk Evaluation Report
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上市药品定期风险效益评估报告
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E2C(R2) Q&As
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Step 5
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2014-3-31
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Questions & Answers: Periodic Benefit-Risk Evaluation Report
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上市药品定期风险效益评估报告的问与答
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E2D
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Step 5
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2003-11-12
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Post-Approval Safety Data Management: Definitions and Standards for Expedited
Reporting
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批准后的安全数据管理：快速报告的定义和标准
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E2E
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Step 5
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2004-11-18
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Pharmacovigilance Planning
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药物警戒计划
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E2F
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Step 5
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2010-8-17
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Development Safety Update Report
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研发安全性更新报告
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E3 Clinical Study Reports （临床研究报告）
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E3
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Step 5
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1995-11-30
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Structure and Content of Clinical Study Reports
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临床研究报告的结构与内容
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E3 Q&As (R1)
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Step 5
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2012-7-6
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Questions & Answers: Structure and Content of Clinical Study Reports
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临床研究报告的结构与内容问与答
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E4 Dose-Response Studies （量-效关系研究）
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E4
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Step 5
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1994-3-10
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Dose-Response Information to Support Drug Registration
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新药注册所需的量-效关系资料
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E5 Ethnic Factors （种族因素）
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E5(R1)
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Step 5
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1998-2-5
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Ethnic Factors in the Acceptability of Foreign Clinical Data
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引入海外临床数据时要考虑的种族因素
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E5 Q&As (R1)
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Step 5
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2006-6-2
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Questions & Answers: Ethnic Factors in the Acceptability of Foreign
Clinical Data
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引入海外临床数据时要考虑的种族因素的问与答
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E6 Good Clinical Practice （药物临床研究质量管理规范）
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E6(R2)
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Step 5
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2016-11-9
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药物临床研究规范
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Good Clinical Practice （GCP）
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E7 Clinical Trials in Geriatric Population （老年人群的临床试验）
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E7
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Step 5
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1993-6-24
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Studies in Support of Special Populations: Geriatrics
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老年人群的临床研究
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E7 Q&As
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Step 5
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2010-7-6
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Questions & Answers: Studies in Support of Special Populations : Geriatrics
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老年人群的临床研究的问与答
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E8 General Considerations for Clinical Trials （临床试验的一般考虑）
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E8
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Step 5
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1997-7-17
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General Considerations for Clinical Trials
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临床试验的一般考虑
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E8(R1)
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Step 1
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Revision on General Considerations for Clinical Trials
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临床试验一般考虑的修订
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E9 Statistical Principles for Clinical Trials （临床试验的统计原则）
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E9
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Step 5
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1998-2-5
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Statistical Principles for Clinical Trials
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临床试验统计原则
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E9(R1)
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Step 3
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Addendum: Statistical Principles for Clinical Trials
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E9附录
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E10 Choice of Control Group in Clinical Trials （临床试验中对照组的选取）
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E10
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Step 5
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2000-7-20
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Choice of Control Group and Related Issues in Clinical Trials
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临床试验的对照组选择及相关问题
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E11 Clinical Trials in Pediatric Population （儿童用药品的临床试验）
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E11
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Step 5
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2000-7-20
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Clinical Investigation of Medicinal Products in the Pediatric Population
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儿童用药品的临床调查
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E11(R1)
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Step 5
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2017-7-20
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Addendum: Clinical Investigation of Medicinal Products in the Pediatric
Population
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E11附录
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E11A
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Step 1
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Paediatric Extrapolation
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儿科外推
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E12 Clinical Evaluation by Therapeutic Category （新抗高血压药的临床评价）
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E12
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Step 5
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2000-3-2
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Principles for Clinical Evaluation of New Antihypertensive Drugs
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新抗高血压药的临床评价原则
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E14 Clinical Evaluation of QT （QT临床评价）
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E14
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Step 5
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2005-5-12
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The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic Drugs
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非抗心律失常药物致QT/QTc间期延长及潜在心律失常作用的临床评价
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E14 Q&As (R3)
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Step 5
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2015-12-10
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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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E14的问与答
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E14/S7B
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Step 1
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Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval
Prolongation
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QT/QTc间期延长的临床和非临床评价讨论组
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E15 Definitions in Pharmacogenetics / Pharmacogenomics （药物遗传学/药物基因组学的定义）
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E15
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Step 5
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2007-11-1
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Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics,
Genomic Data and Sample Coding Categories
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基因组生物标记物、药物基因组学、遗传药理学、基因组数据和样本编码分类的定义
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E16 Qualification of Genomic Biomarkers （基因组生物标记物的条件）
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E16
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Step 5
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2010-8-20
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Biomarkers Related to Drug or Biotechnology Product Development: Context,
Structure and Format of Qualification Submissions
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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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E17 Multi-Regional Clinical Trials （国际多中心临床试验）
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E17
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Step 5
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2017-11-16
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General principle on planning/designing Multi-Regional Clinical Trials
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国际多中心临床试验计划与设计原则
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E18 Genomic Sampling （基因组采样）
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E18
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Step 5
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2017-8-3
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Genomic Sampling and Management of Genomic Data
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基因组样品采集和基因组数据管理指南
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E19 Safety Data Collection （安全性数据收集）
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E19
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Step 1
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Optimisation of Safety Data Collection
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安全性数据收集的优化
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