| E1 | Step 5 | The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions
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 |
| E2A | Step 5 | Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
临床安全性数据管理：快速报告的定义和标准 |
| E2B(R3) | Step 5 | Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
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 |
| E2B(R3) IWG | Step 5 | Implementation: Electronic Transmission of Individual Case Safety Reports
关于E2B(R3)实施的问与答 |
| E2C(R2) | Step 5 | Periodic Benefit-Risk Evaluation Report
上市药品定期风险效益评估报告 |
| E2C(R2) Q&As | Step 5 | Questions & Answers: Periodic Benefit-Risk Evaluation Report
上市药品定期风险效益评估报告的问与答 |
| E2D | Step 5 | Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
批准后的安全数据管理：快速报告的定义和标准 |
| E2E | Step 5 | Pharmacovigilance Planning
药物警戒计划 |
| E2F | Step 5 | Development Safety Update Report
研发安全性更新报告 |
| E3 | Step 5 | Structure and Content of Clinical Study Reports
临床研究报告的结构与内容 |
| E3 Q&As (R1) | Step 5 | Questions & Answers: Structure and Content of Clinical Study Reports
临床研究报告的结构与内容问与答 |
| E4 | Step 5 | Dose-Response Information to Support Drug Registration
新药注册所需的量-效关系资料 |
| E5(R1) | Step 5 | Ethnic Factors in the Acceptability of Foreign Clinical Data
引入海外临床数据时要考虑的种族因素 |
| E5 Q&As (R1) | Step 5 | Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data
引入海外临床数据时要考虑的种族因素的问与答 |
| E6(R1) | Step 5 | Good Clinical Practice
药品临床研究规范（GCP）一致性指导原则 |
| E6(R2) | Step 5 | Integrated Addendum to Good Clinical Practice (GCP)
2016版ICH GCP |
| E7 | Step 5 | Studies in Support of Special Populations: Geriatrics
老年人群的临床研究 |
| E7 Q&As | Step 5 | Questions & Answers: Studies in Support of Special Populations : Geriatrics
老年人群的临床研究的问与答 |
| E8 | Step 5 | General Considerations for Clinical Trials
临床试验的一般考虑 |
| E9 | Step 5 | Statistical Principles for Clinical Trials
临床试验统计原则 |
| E9(R1) | Step 1 | Addendum: Statistical Principles for Clinical Trials
E9附录 |
| E10 | Step 5 | Choice of Control Group and Related Issues in Clinical Trials
临床试验的对照组选择及相关问题 |
| E11 | Step 5 | Clinical Investigation of Medicinal Products in the Pediatric Population
儿童用药品的临床调查 |
| E11(R1) | Step 3 | Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
E11附录 |
| E12 | Step 5 | Principles for Clinical Evaluation of New Antihypertensive Drugs
新抗高血压药的临床评价原则 |
| E14 | Step 5 | The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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 |
| E14 Q&As (R3) | Step 5 | Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
E14的问与答 |
| E14/S7B | Step 1 | Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation
QT/QTc间期延长的临床和非临床评价讨论组 |
| E15 | Step 5 | Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
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 |
| E16 | Step 5 | Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions
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 |
| E17 | Step 3 | General principle on planning/designing Multi-Regional Clinical Trials
国际多中心临床试验计划与设计原则 |
| E18 | Step 3 | Genomic Sampling and Management of Genomic Data
基因组样品采集和基因组数据管理指南 |
