人用药品技术要求国际协调理事会指南
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指导 人用药品技术要求国际协调理事会指南 药品和保健品监管局已实施的人用药品技术要求国际协调理事会（ICH）现行指南目录。 来自： 药品和保健品监管局 发布日期： 2024年4月4日 最后更新日期： 2026年11月5日 — 查看所有更新 订阅此页面的电子邮件 打印此页面 目录 关于ICH 质量指南 安全性指南 有效性指南 多学科指南 关于ICH 人用药品技术要求国际协调理事会（ICH）旨在创建一个国际合作网络，使人们能够介绍本国的最佳实践、向其他国家学习，并在本国实施最佳实践。该理事会汇集了监管机构和制药行业，共同审视药品注册的科学和技术方面。 该小组讨论制药的科学和实践方面，在四个领域制定指南——“安全性”、“质量”、“有效性”和“多学科”。这些指南的制定及后续实施旨在实现全球协调统一。ICH的总体目标是确保以最节约资源的方式开发和注册安全、有效和高质量的药品。 在英国退出欧盟之前，MHRA在欧盟体系下是ICH的一部分。当时使用的指南作为欧盟指导文件被沿用，并在《2012年人用药品条例》中被引用。 在英国退出欧盟之后，MHRA于2022年5月成为ICH的正式成员。本页面作为MHRA已实施的现行ICH指南的目录。 随着MHRA实施新的指南，本页面将予以更新。 质量指南 Q1A(R2) – 新原料药和制剂的稳定性试验 Q1B – 稳定性试验：新原料药和制剂的光稳定性试验 Q1C – 新剂型的稳定性试验 Q1D – 新原料药和制剂稳定性试验的括号法和矩阵法设计 Q1E – 稳定性数据的评价 Q3A(R2) – 新原料药中的杂质 Q3B(R2) – 新制剂中的杂质 Q3D(R2) – 元素杂质指南 Q4B – 在ICH地区使用的药典文本的评价和推荐 Q4B 附录1(R1) – 炽灼残渣/硫酸化灰分通则 Q4B 附录2(R1) – 注射剂可抽取体积试验通则 Q4B 附录3(R1) – 颗粒污染试验：亚可见颗粒通则 Q4B 附录4A(R1) – 非无菌产品的微生物检查：微生物计数试验通则 Q4B 附录4B(R1) – 非无菌产品的微生物检查：特定微生物试验通则 Q4B 附录 4C（R1）——非无菌产品的微生物检查：药用制剂和药用物质的可接受标准通则 Q4B 附录 5（R1）崩解时限检查法通则 Q4B 附录 6——剂量单位均匀度通则 Q4B 附录 7（R2）——溶出度检查法通则 Q4B 附录 8（R1）——无菌检查法通则 Q4B 附录 9（R1）——片剂脆碎度通则 Q4B 附录 10（R1）——聚丙烯酰胺凝胶电泳通则 Q4B 附录 11——毛细管电泳通则 Q4B 附录 12——分析筛分法通则 Q4B 附录 13——粉末的松密度和振实密度通则 Q4B 附录 14——细菌内毒素检查法通则 Q5B——用于生产r-DNA衍生蛋白质产品的细胞中表达构建体的分析 Q5C——生物技术产品的质量：生物技术/生物制品的稳定性试验 Q5D——用于生产生物技术/生物制品的细胞基质的来源和特性鉴定 Q5E——生产工艺变更后的生物技术/生物制品的可比性 Q6A——质量标准：新原料药和新药物制剂的检查方法和可接受标准：化学物质 Q6B——质量标准：生物技术/生物制品的检查方法和可接受标准 Q7——原料药药品生产质量管理规范指南 Q7——问答 Q8（R2）——药品研发 Q9（R1）——质量风险管理 Q10——药品质量体系 Q11——原料药的开发与生产（化学实体及生物技术/生物实体） Q11——问题与解答 Q13——原料药和药品的连续制造 安全性指南 S1A——药品致癌性研究的必要性 S1B（R1）——药品致癌性试验 S1C（R2）——药品致癌性研究的剂量选择 S2（R1）——人用药品遗传毒性试验和数据解释指南 S3A——毒代动力学指南说明：毒性研究中全身暴露的评估 S3A——问题与解答 S3B——药代动力学：重复给药组织分布研究指南 S4——动物慢性毒性试验持续时间（啮齿类和非啮齿类毒性试验） S5（R3）——S5人用药品生殖毒性检测指南修订版 S6（R1）——生物技术衍生药品的临床前安全性评价 S7A——人用药品安全药理学研究 S7B——人用药品延迟心室复极化（QT间期延长）潜力的非临床评价 S8——人用药品免疫毒性研究 S9——抗癌药品的非临床评价 S10——药品光安全性评价 S11——支持儿科药物开发的非临床安全性试验 有效性指南 E1 - 评估用于非危及生命疾病长期治疗药物的临床安全性所需的人群暴露程度 E2A – 临床安全性数据管理：快速报告的定义和标准 E2B(R3) – 临床安全性数据管理：个例安全性报告（ICSRs）传输的数据元素 E2B(R3) – 问题与解答 E2C(R2) – 定期获益-风险评估报告 E2C(R2) – 问题与解答 E2D – 上市后安全性数据管理：快速报告的定义和标准 E2D(R1) – 上市后安全性数据指南：个例安全性报告管理和报告的定义和标准 E2E – 药物警戒计划 E2F – 研发安全性更新报告 E3 – 临床研究报告的结构和内容 E3 – 问题与解答（R1） E4 – 支持药物注册的剂量-效应信息 E5(R1) – 国外临床数据可接受性中的种族因素 E5 – 问题与解答 E6(R3) – 药物临床试验质量管理规范指南 E7 – 支持特殊人群研究：老年医学 E7 – 问题与解答 E8(R1) – 临床研究的一般考虑 E9 – 临床试验的统计学原则 E9(R1) – 增补：临床试验的统计学原则 E10 – 临床试验中对照的选择及相关问题 E11(R1) – 儿科人群中药品的临床研究：指南及增补 E14 – 非抗心律失常药物QT/QTc间期延长及致心律失常潜力的临床评价 E14 – 问答（R3） E15 – 基因组生物标志物、药物基因组学、药物遗传学、基因组数据和样本编码类别的定义 E16 – 与药物或生物技术产品开发相关的生物标志物：资格认定的背景、结构和格式 E17 – 多区域临床试验规划和设计的一般原则 E18 – 基因组样本和基因组数据管理 多学科指南 M1 – MedDRA – 监管活动医学词典 M3(R2) – 药物人体临床试验实施和上市许可的非临床安全性研究指南 M3(R2) – 问答（R2） M4(R4) – 组织，包括提供文件位置和页码编排指导的粒度文件 M4 – 问答（R3） M4Q(R1) – CTD质量部分 M4Q – 问答（R1） M4S(R2) – CTD安全性部分 M4S – 问答（R2） M4E(R2) – CTD有效性部分 M4E – 问答（R4） M7(R2) – 药物中DNA反应性（致突变性）杂质的评估与控制以限制潜在致癌风险 M7(R2) – 附录 药物中DNA反应性（致突变性）杂质的评估与控制以限制潜在致癌风险 M8 – 电子通用技术文件（eCTD）v3.2.2 M8 – 电子通用技术文件（eCTD）v4.0 M9 – 基于生物药剂学分类系统的生物豁免 M9 – 问答 M10 – 生物分析方法验证和研究样品分析 M12 – 药物相互作用研究指南 M13A – 速释固体口服制剂的生物等效性 M15 – 模型引导药物开发的一般原则指南 本页更新 最后更新： 2026年11月5日 显示所有更新 2026年11月5日 更新了指南链接： - E2D(R1) – 上市后安全性数据指南：个例安全性报告管理与报告的定义和标准 - E8(R1) – 临床研究一般考虑指南 - M12 – 药物相互作用研究指南 - M15 – 模型引导药物开发的一般原则指南 - Q13 – 原料药和药品连续生产指南 - E6(R3) – 药物临床试验质量管理规范指南 2026年5月19日 添加了“Q13 – 原料药和药品连续生产”的链接 2026年4月28日 新增指南： - E6(R3) – 药物临床试验质量管理规范指南（替代E6(R2)） - E8(R1) – 临床研究一般考虑 2026年3月25日 更新了“质量指南”部分中的链接 2024年12月19日 修订以添加M13A – 速释固体口服制剂的生物等效性 2024年4月4日 首次发布。 订阅电子邮件或打印本页 获取关于本页的电子邮件 打印本页 目录 探索主题 药品、医疗器械
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Guidance International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency. From: Medicines and Healthcare products Regulatory Agency Published: 4 April 2024 Last updated: 5 November 2026 — See all updates Get emails about this page Print this page Contents About ICH Quality Guidelines Safety Guidelines Efficacy Guidelines Multidisciplinary Guidelines About ICH The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) aims to create an international collaborative network where people can bring forth best practices from their countries, learn from other countries, and implement best practices in their own country. It brings together the regulatory bodies and pharmaceutical industry to look at the scientific and technical aspects of drug registration. The group discusses the scientific and practical aspects of pharmaceuticals, producing guidelines in four areas – ‘safety’, ‘quality’, ‘efficacy’ and ‘multidisciplinary’. The development and subsequent implementation of these guidelines aims to achieve global harmonisation. The overall aim of ICH is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Before the UK’s exit from the EU, the MHRA was part of ICH under the EU system. Guidelines in use at that time were carried over as EU guidance documents referred to in the Human Medicines Regulations 2012. Following the UK’s exit from the EU, MHRA became a full Member of ICH in May 2022. This page serves as a directory for current ICH Guidelines which have been implemented by the MHRA. This page will be updated as new guidelines are implemented by the MHRA. Quality Guidelines Q1A(R2) – Stability Testing of New Drug Substances and Products Q1B – Stability Testing: Photostability Testing of New Drug Substances and Products Q1C – Stability Testing for New Dosage Forms Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1E – Evaluation of Stability Data Q3A(R2) – Impurities in New Drug Substances Q3B(R2) – Impurities in New Drug Products Q3D(R2) – Guideline for Elemental Impurities Q4B – Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions Q4B Annex 1(R1) – Residue on Ignition/Sulphated Ashe General Chapter Q4B Annex 2(R1) – Test for Extractable Volume of Parenteral Preparations General Chapter Q4B Annex 3(R1) – Test for Particulate Contamination: Sub-Visible Particles General Chapter Q4B Annex 4A(R1) – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Q4B Annex 4B(R1) - Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter Q4B Annex 4C(R1) - Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Q4B Annex 5(R1) Disintegration Test General Chapter Q4B Annex 6 – Uniformity of Dosage Units General Chapter Q4B Annex 7(R2) – Dissolution Test General Chapter Q4B Annex 8(R1) – Sterility Test General Chapter Q4B Annex 9(R1) – Tablet Friability General Chapter Q4B Annex 10(R1) – Polyacrylamide Gel Electrophoresis General Chapter Q4B Annex 11 – Capillary Electrophoresis General Chapter Q4B Annex 12 – Analytical Sieving General Chapter Q4B Annex 13 – Bulk Density and Tapped Density of Powders General Chapter Q4B Annex 14 – Bacterial Endotoxins Test General Chapter Q5B – Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5D – Derivation and Characterisation of Cell Substrates Used for Productions of Biotechnological/Biological Products Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6B – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7 – Questions and Answers Q8(R2) – Pharmaceutical Development Q9(R1) – Quality Risk Management Q10 – Pharmaceutical Quality System Q11 – Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11 – Questions and Answers Q13 – Continuous Manufacturing of Drug Substances and Drug Products Safety Guidelines S1A – Need for Carcinogenicity Studies for Pharmaceuticals S1B(R1) – Testing for Carcinogenicity of Pharmaceuticals S1C(R2) – Dose Selection for Carcinogenicity Studies of Pharmaceuticals S2(R1) – Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S3A – Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A – Questions and Answers S3B – Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies S4 – Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S5(R3) – Revision of S5 Guidelines on Detection of Toxicity to Reproduction for Human Pharmaceuticals S6(R1) – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S7A – Safety Pharmacology Studies for Human Pharmaceuticals S7B – The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals S8 – Immunotoxicity Studies for Human Pharmaceuticals S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals S10 – Photosafety Evaluation of Pharmaceuticals S11 – Nonclinical Safety Testing in Support of Development of Paediatric Medicines Efficacy Guidelines E1 - The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2B(R3) – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) – Questions and Answers E2C(R2) – Periodic Benefit-Risk Evaluation Report E2C(R2) – Questions and Answers E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D(R1) – Guideline for Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports E2E – Pharmacovigilance Planning E2F – Development Safety Update Report E3 – Structure and Content of Clinical Study Reports E3 – Questions and Answers (R1) E4 – Dose-Response Information to Support Drug Registration E5(R1) – Ethnic Factors in the Acceptability of Foreign Clinical Data E5 – Questions and Answers E6(R3) – Guideline for Good Clinical Practice E7 – Studies in Support of Special Populations: Geriatrics E7 – Questions and Answers E8(R1) – General Considerations for Clinical Studies E9 – Statistical Principles for Clinical Trials E9(R1) – Addendum: Statistical Principles for Clinical Trials E10 – Choice of Control Group and Related Issues in Clinical Trials E11(R1) – Clinical Investigation of Medicinal Products in the Pediatric Populations: Guideline and Addendum E14 – The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14 – Questions and Answers (R3) E15 – Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories E16 – Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions E17 – General Principles for planning and design of Multi-Regional Clinical Trials E18 – Genomic Samples and Management of Genomic Data Multidisciplinary Guidelines M1 – MedDRA – Medical Dictionary for Regulatory Activities M3(R2) – Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2) – Questions and Answers (R2) M4(R4) – Organisation Including the Granularity document that provides guidance on document location and paginations M4 – Questions and Answers (R3) M4Q(R1) – CTD on Quality M4Q – Questions and Answers (R1) M4S(R2) – CTD on Safety M4S – Questions and Answers (R2) M4E(R2) – CTD on Efficacy M4E – Questions and Answers (R4) M7(R2) – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7(R2) – Addendum Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M8 – Electronic Common Technical Document (eCTD) v3.2.2 M8 – Electronic Common Technical Document (eCTD) v4.0 M9 – Biopharmaceutics Classifcation System-based Biowaivers M9 – Questions and Answers M10 – Bioanalytical Method Validation and Study Sample Analysis M12 – Guideline for Drug Interaction Studies M13A – Bioequivalence for Immediate-Release Solid Oral Dosage Forms M15 – Guideline for General Principles for Model-Informed Drug Development Updates to this page Last updated: 5 November 2026 Show all updates 5 November 2026 Updated links to guidelines: - E2D(R1) – Guideline for Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports - E8(R1) – Guideline for General Considerations for Clinical Studies - M12 – Guideline for Drug Interaction Studies - M15 – Guideline for General Principles for Model-Informed Drug Development - Q13 – Guideline for Continuous Manufacturing of Drug Substances and Drug Products - E6(R3) – Guideline for Good Clinical Practice 19 May 2026 Added a link to 'Q13 – Continuous Manufacturing of Drug Substances and Drug Products' 28 April 2026 New guidelines added: - E6(R3) – Guideline for Good Clinical Practice (replacement for E6(R2)) - E8(R1) – General Considerations for Clinical Studies 25 March 2026 Updated links in the 'Quality guidelines' section 19 December 2024 Amended to add M13A – Bioequivalence for Immediate-Release Solid Oral Dosage Forms 4 April 2024 First published. 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