ICH指导原则 - 蒲标网

Efficacy Guidelines
有效性

编号	阶段	内容
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

【以上内容源于网络收集整理，如有出入以官网为准】