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I C H-系列指导原则-CAL-FENGHAI-(2020YEAR-YICAI)_JINGBIANICH：Quality质量Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)新原料药和制剂的稳定性试验（第二版）Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV 在气候带III和IV，药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validation of Analytical Procedures: Methodology分析程序的验证：方法学Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质（修订版）Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质（修订版）Q3C: Impurities: Guideline for Residual Solvents杂质：残留溶剂指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)杂质：残留溶剂指南（修改内容）Q4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C:Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH：Safety安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C(R): Addendum: Addition of a Limit Dose and Related Notes附录：极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性：药物基因毒性检验的标准S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies药物代谢动力学：重复剂量的组织分布研究指南S4:??Single Dose Toxicity Tests单剂量毒性检验S4A:??Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A: Detection of Toxicity to Reproduction for Medicinal Products药物对生殖发育的毒性的检验S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility:??An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting临床安全数据管理：速报制度的定义和标准E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版E2B (M): Maintenance of the Clinical Safety Data Management including: Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M): Maintenance of the Clinical Safety Data Management including Questions and Answers临床安全数据管理的变动，包括问答E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs临床安全数据管理：已上市药品的周期性安全数据更新报告Addendum to E2C: Periodic Safety Update Reports for Marketed DrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting批准后的安全数据管理：速报制度的定义和标准E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量－效应资料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP：良好的临床规范：统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究：老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinical Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the Pediatric Population小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics)有关临床试验的临床前研究的时间安排M4: The Common Technical Document (See CTD section for complete Status of the guidelines)通用技术文件（见有关CTD章节）M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准。
ich指导原则心得ICH的论题主要分为四类，因此ICH根据论题的类别不同而进行相应的编码分类：1. “Q”类论题：Q代表QUALITY，指那些与化工和医药，质量保证方面的相关的论题。
2. “S”类论题：S代表SAFETY，指那些与实验室和动物实验，临床前研究方面的相关的论题。
3. “E”类论题：E代表EFFICACY，指那些与人类临床研究相关的课题。
4. “M”类论题：M代表MULTIDISCIPLINARY, 指那些不可单独划入以上三个分类的交叉涉及的论题。
同时M又细分为5个小类M1: 常用医学名词（MedDRA）M2: 药政信息传递之电子标准M3: 与临床试验相关的临床前研究时间的安排M4: 常规技术文件(CTD)M5: 药物词典的数据要素和标准Quality质量：Q1: Stability稳定性Q 1A(R2): Stability Testing of New Drug Substances and Products新原料药和制剂的稳定性试验Q1B: Photostability Testing of New Drug Substances and Products 新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新剂型的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data稳定性数据的评估Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2: Analytical Validation分析验证Q2(R1): Validation of Analytical Procedures: Text and Methodology分析程序的验证：正文及方法论Q3: Impurities 杂质Q3A(R2): Impurities in New Drug Substances新原料药中的杂质Q3B(R2): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质Q3C(R3): Impurities: Guideline for Residual Solvents杂质：残留溶剂指南Impurities: Guideline for Residual Solvents (Maintenance) 杂质：残留溶剂指南(保留)PDE for Tetrahydrofuran (in Q3C(R3)) 四氢呋喃的PDEPDE for N-Methylpyrrolidone (in Q3C(R3)) N-甲基吡咯烷酮的PDEQ4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions药典内容的评估及推荐为用于ICH地区Q4B Annex1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regionson Residue on Ignition/Sulphated Ash General Chapter附录1 药典内容的评估及推荐为用于ICH地区关于灼烧残渣/灰分常规篇Q4B Annex2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regionson Test for Extractable Volume of Parenteral Preparations General Chapter附录2 药典内容的评估及推荐为用于ICH地区关于注射剂可提取容量测试常规篇Q4B Annex3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regionson Test for Particulate Contamination: Sub-Visible Particles General Chapter附录3 药典内容的评估及推荐为用于ICH地区关于颗粒污染物测试:不溶性微粒常规篇Q5: Quality of Biotechnological Products 生物技术制品质量Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products 生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications 规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including decision trees)质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质(包括决定过程)Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7: Good Manufacturing Practices （GMP）Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理Q10: Pharmaceutical Quality System 药物质量体系Q11： DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES 原料药开发和生产。
INTRODUCTION 简介This document is complementary to the parent document, which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure.In some cases (for example, demonstration of specificity), the overall capabilities of a number of analytical procedures in combination may be investigated in order to ensure the quality of the drug substance or drug product. In addition, the document provides an indication of the data, which should be presented in a registration application.本文作为前文的补充，旨在讨论在分析方法验证过程中在每一个具体的项目需要考虑哪些内容。
本文的目的是就不同类型的验证该涵盖哪些项目提供一个指导原则和建议。
以专属性为例，为了确保原料药或制剂的质量，需要考察分析过程对化合物中杂质的全面综合分析能力。
另外，文件提供的数据应该包含在注册申请材料中。
ICHQSEM指导原则有哪些？马上给您列出来一、总目录类别主要内容ICH指导原则数量Quality Guidelines 质量指导原则化工、医药、质量保证相关指导原则44Safety Guidelines 安全性指导原则实验室动物实验等临床前研究相关指导原则16Efficacy Guidelines有效性指导原则人类临床研究相关指导原则30Multidisciplinary Guidelines多学科指导原则内容交叉涉及以上三个分类，不可单独划入任何一类的指导原则59总数149二、分目录2.1质量(Quality Guidelines)编号英文题目中文译文发布时间Q1 Stability/稳定性Q1A(R2): Stability Testing ofNew Drug Substances andProductsQ1A(R2)：新型原料药和药品的稳定性测试2003.2.6Q1B: Stability Testing:Photostability Testing of NewDrug Substances and ProductsQ1B: 稳定性测试: 新型原料药和药品的光稳定性测试1996.11.6Q1C: Stability Testing for NewDosage FormsQ1C：新剂型的稳定性1996.11.6测试Q1D: Bracketing and MatrixingDesigns for Stability Testingof New Drug Substances andProductsQ1D ：新型原料药和药品稳定性测试的交叉和矩阵设计 2002.2.7Q1E: Evaluation for StabilityDataQ1E ：稳定性数据的评价2003.2.6Q1F: Stabilitiy Guidelines_WHO Q1F ：WHO 稳定性指导原则2009Q2 Analytical Validation/分析方法验证 Q2(R1): Validation of Analytical Procedures Text and Methodology Q2(R1): 分析过程和方法的确证2005.11 Q3A - Q3DImpurities/杂质Q3A(R2): Impurities in New Drug Substances Q3A(R2): 新型原料药中的杂质问题 2006.10.25Q3B(R2): Impurities in New DrugProductsQ3B(R2): 新型药品中的杂质问题2006.6.2Q3C(R6): Impurities Guideline for Residual Solvents Q3C(R6)：杂质：残留溶剂的指导原则2016.10.20Q3D: Guideline for Elemental Impurities Q3D ：元素杂质的指导原则2014.12.16Q4 - Q4BPharmacopoeias/药典 Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B ：ICH 区域所用药典文本的评价和建议2007.11.1Q4B Frequently Asked Questions Q4B ：常见问题与解答2012.4.26Q4B Annex 1 (R1): Residue onIgnition/Sulphated Ash General ChapterQ4B 附录1(R1): 关于灼烧残渣/灰分 常规篇2010.9.27Q4B Annex 2 (R1): Test for Extractable Volume of Parenteral Preparations General Chapter Q4B 附录2(R1): 关于注射剂可提取容量测试2010.9.27常规篇Q4B Annex 3 (R1): Test for Particulate Contamination: Sub-Visible Particles General Chapter Q4B 附录3(R1): 关于颗粒污染物测试:不溶性微粒 常规篇2010.9.27Q4B Annex 4A (R1):Microbiological Examination ofNon-SterileProducts: MicrobialEnumeration Tests GeneralChapterQ4B 附录4A(R1):非无菌药品的微生物检查：微生物计数试验 常规篇2010.9.27Q4B Annex 4B (R1):Microbiological Examination ofNon-Sterile Products Tests for Specified Micro-OrganismsGeneral ChapterQ4B 附录4B(R1): 非无菌产品的微生物检查—特定微生物 常规篇 2010.9.27Q4B Annex 4C (R1):Microbiological Examination ofNon-SterileProducts: AcceptanceCriteria for PharmaceuticalPreparations and Substancesfor Pharmaceutical UseGeneral ChapterQ4B 附录4C(R1): 非无菌产品的微生物检查：药物制备以及药物使用物质的接受标准 常规篇2010.9.27Q4B Annex 5 (R1):Disintegration Test General ChapterQ4B 附录5（R1）：崩解试验 常规篇2010.9.27Q4B Annex 6 Uniformity of Dosage Units General Chapter Q4B 附录6: 统一剂量单位常规篇2013.11.13Q4B Annex 7 (R2): Dissolution Test General Chapter Q4B 附录7(R2): 溶出试验 常规篇2010.11.11Q4B Annex 8 (R1): Sterility Test General Chapter Q4B 附录8(R1): 无菌2010.9.27试验 常规篇Q4B Annex 9 (R1): Tablet Friability General Chapter Q4B 附录9(R1): 片剂易碎性 常规篇2010.9.27Q4B Annex 10 (R1):Polyacrylamide GelElectrophoresis GeneralChapterQ4B 附录10(R1): 聚丙烯酰胺凝胶电泳 常规篇2010.9.27Q4B Annex 11: Capillary Electrophoresis General Chapter Q4B 附录11：毛细管电泳 常规篇2010.6.9 Q4B Annex 12: AnalyticalSieving General ChapterQ4B 附录12：分析筛选 常规篇 2010.6.9Q4B Annex 13: Bulk Density andTapped Density of Powders General ChapterQ4B 附录13：粉末的堆密度和振实密度 2012.6.7Q4B Annex 14: BacterialEndotoxins Test GeneralChapterQ4B 附录14：细菌内毒素试验 常规篇2012.10.18Q5A - Q5E Quality of Biotechnological Products/生物技术产品质量 Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A(R1):人或者动物细胞系来源的生物技术产品的病毒安全性评估 1999.9.23Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5B: 关于重组DNA 来源的蛋白质产品生产所用的细胞中表达构建的分析1995.11.30 Q5C: Stability Testing ofBiotechnological/BiologicalProductsQ5C: 生物技术/生物产品的稳定性试验1995.11.3Q5D:Derivationand Q 5D: 用于生1997.7.16Characterisation of Cell Substrates Used for Production of BiotechnologicalBiological Products 产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of BiotechnologicalBiological Products Subject to Changes in their Manufacturing Process Q5E: 基于不同生产工艺的生物技术产品/生物产品的可比较性2004.11.18 Q6A- Q6BSpecifications/规格 Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6A: 质量规格：新原料药和药品的检验程序和可接收标准：化学物质 1999.10.6 Q6B: Specifications: TestProcedures and AcceptanceCriteria for Biotechnological/Biological ProductsQ6B: 质量规格：生物技术/生物产品的检验程序和可接收标准1999.3.10Q7 GoodManufacturingPractice/GMP Q7: Good ManufacturingPractice Guide for Active Pharmaceutical Ingredients Q7: 原料药GMP 指南 2000.11.1Q7 Questions and Answers Q7 问答部分2015.6.10Q8 Pharmaceutica l Development/药物研发 Q8(R2): Pharmaceutical DevelopmentQ8(R2): 药物研发 2009.8Q8, Q9 and Q10 Questions & Answers (R4) Q8/Q9/Q10问答部分(R4)2010.11.11Q9 Quality RiskManagement/质量风险管理Q9: Quality Risk ManagementQ9: 质量风险管理 2005.11.09Q10 Pharmaceutical Quality System/药物质量体系Q10: Pharmaceutical Quality System Q10: 药物质量体系2008.6.4Q11 Development and Manufacture of Drug Substances/化Q11: Development and Manufacture of Drug Substances (Chemical Entities and Q11：化学药品的研发与生产（化2012.5.1学药品的研发与生产 Biotechnological/BiologicalEntities)学实体以及生物科技/生物制品）Q11：Questions and AnswersQ11：问答部分 2016.10.132.2安全性(Safety Guidelines)编号英文题目 中文译文 发布时间S1A - S1C Carcinogenicity Studies/致癌性研究S1A: Need for Carcinogenicity Studies of Pharmaceuticals S1A: 药物致癌性的研究需求 1995.11.29 S1B: Testing forCarcinogenicity of PharmaceuticalsS1B: 药物致癌性测试1997.7.16S1C(R2): Dose Selectionfor Carcinogenicity Studies of PharmaceuticalsS1C(R2): 药物致癌性研究的剂量选择2008.3.11S2 GenotoxicityStudies/基因毒性研究S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S2(R1): 关于人用药基因毒性试验和数据解读的指导原则2011.11.9S3A - S3BToxicokinetics andPharmacokinetics/毒代动力学和药代动力学S3A: Note for Guidance onToxicokinetics: TheAssessment of Systemic Exposure inToxicity StudiesS3A ：毒理动力学指导原则说明：毒性研究中系统性暴露的评价1994.10.27S3A Implementation Working Group Questions and Answers S3A 实施工作组问答：毒代动力学指导原则说明：毒性研究中的全身暴露量评价集中于微量采样（中文版：征求意见稿）2016.1.19 S3B: Pharmacokinetics Guidance for Repeated Dose S3B ：关于重复剂量组织1994.10.27TissueDistribution Studies分布研究的药代动力学指导原则 S4 ToxicityTesting/毒性试验S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S4：动物慢性毒性试验的持续时间（啮齿动物和非啮齿动物毒性试验）1998.9.2S5 Reproductive Toxicology/生殖毒性 S5(R2):Detection ofToxicity to Reproductionfor Medicinal Products &Toxicity to Male FertilityS5(R2): 检测药品的生殖毒性以及对雄性生殖能力的毒性 2000.11S6 Biotechnological Products/生物技术产品 S6(R1): Preclinical SafetyEvaluation ofBiotechnology-Derived PharmaceuticalsS6(R1): 生物科技来源药品的临床前安全性评价2011.6.12S7A - S7B Pharmacology Studies/药理学研究 S7A: SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS S7A ：人用药的安全性药理学研究 2000.11.8 S7B: The Non-ClinicalEvaluation of thePotential forDelayed Ventricular Repolarization (QTInterval Prolongation) byHuman PharmaceuticalsS7B ：人用药延迟心室复极化（QT 间期延长）潜力的非临床评价2005.5.12S8 Immunotoxicology Studies 免疫毒理学研究 S8: Immunotoxicity Studiesfor Human PharmaceuticalsS8：人用药免疫毒性研究2005.9.15S9 NonclinicalEvaluation forAnticancerPharmaceuticals/抗癌药物的非临床评价S9: Nonclinical Evaluation for Anticancer Pharmaceuticals S9：抗癌药物的非临床评价2009.10.29S9 Implementation Working Group Questions and Answers S9 实施工作组问答部分2016.6.8S10 Photosafety Evaluation/光安全性评价 S10: Photosafety Evaluation of Pharmaceuticals S10：药物的光安全性评价2013.11.132.3有效性(Efficacy Guidelines)编号英文题目中文译文发布时间E1 Clinical Safety for Drugs used in Long-Term Treatment/长期使用的药物的临床安全性 E1: The extent of PopulationExposure to Assess ClinicalSafety for Drugs Intended for Long-term Treatment of Non-life-threateningConditionsE1: 用于评估长期治疗非危及生命性疾病的药物临床安全性的人群暴露程度1994.10.27E2A - E2FPharmacovigilance/药物警戒性E2A: Clinical Safety DataManagement: Definitions and Standards for Expedited ReportingE2A: 临床安全性数据管理：快速报告的定义和标准（中文版：征求意见稿） 1994.10.27E2B(R3):ImplementationGuide for ElectronicTransmission ofIndividual Case SafetyReports (ICSRs) E2B(R3)Data Elements and MessageSpecificationE2B(R3):个例安全报告（ICSR ）电子传输执行指导原则 E2B （R3）数据元素和信息规范元素（中文版：征求意见稿） 2016.11.10 E2B(R3) QA document_v2_1 E2B(R3) 问答文件（中文版：征求意见稿） 2017.6.1E2C(R2): Periodic Benefit-Risk Evaluation Report E2C(R2):定期获益—风险2012.12.17间评估报告E2C(R2) Implementation Working Group Questions & Answers E2C(R2)实施工作组问答部分2014.3.31E2D: Post-Approval SafetyData Management: Definitions and Standards for Expedited ReportingE2D: 上市后安全性数据的管理：快速报告的定义和标准（中文版：征求意见稿） 2003.11.12E2E: Pharmacovigilance Planning E2E:药物警戒规性划2004.11.18E2F: Development Safety Update Report E2F: 研发安全性更新报告 2010.8.17E3 Clinical StudyReports/临床研究报告 E3: Structure and Content of Clinical Study Reports E3: 临床研究报告的结构与内容 1995.11.30E3 Questions & Answers(R1) ： Structure and Content of Clinical Study ReportsE3 实施工作组 问答部分2012.7.6E4 Dose-Response Studies/剂量反应研究 E4: Dose-Response Information to Support Drug Registration E4: 用于支持药物注册的剂量反应信息 1994.3.10E5 Ethnic Factors/种族因素E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data E5(R1):国外临床数据可接受性的种族因素1998.2.5E5 Implementation WorkingGroup Questions & Answers(R1)E5 实施工作组 问答部分（R1）2006.6.2间E6 GCP/药物临床试验管理规范 E6(R1): Guideline for Good Clinical Practice E6(R1):药物临床试验管理规范指导原则 1996.6.10E6(R2):Integrated Addendum to Good Clinical Practice (GCP) E6(R2):药物临床试验管理规范综合附录2016.11.9E7 Clinical Trials inGeriatric Population/老人中开展的临床试验E7: Studies in Support of Special Populations: GeriatricsE7: 特殊人群的支持性研究：老人病学 1993.6.24E7 Questions & AnswersE7 问答部分 2010.7.6E8 GeneralConsiderations for Clinical Trials/临床试验的一般性考虑 E8: General Considerations for Clinical Trials E8: 临床试验的一般性考虑1997.7.17E9 StatisticalPrinciples for Clinical Trials/临床试验的统计原则E9: Statistical Principles for Clinical Trials E9: 临床试验的统计原则1998.2.5E10 Choice of Control Group in Clinical Trials/试验中对照组的选择 E10: Choice of Control Group and Related Issues in Clinical Trials E10: 临床试验中对照组的选择以及相关问题2000.7.20E11 Clinical Trials inPediatric Population/儿童人群临床研究 E11: Clinical Investigation of Medicinal Products in the Pediatric Population E11：儿科人群药物临床试验 2000.7.20E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population E11(R1): 儿科人群药物临床试验补充2017.8.18 E12 Clinical Evaluation by Therapeutic Category/根据治疗类别进行临床评价 E12: Principles for Clinical Evaluation of New Antihypertensive Drugs E12: 新型抗高血压药物的临床评价原则2000.3.2间E14 Clinical Evaluationof QT/QT 临床评价E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 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2005.5.12E14 Implementation Working Group Questions & Answers (R3) E14 实施工作组 问答部分（R3）2015.12.10 E15 Definitions in Pharmacogenetics/Pharmac ogenomics/药物基因组学以及遗传药理学相关定义 E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmac ogenetics, Genomic Data and Sample Coding Categories E15: 基因组生物标志物、药物基因组学、遗传药理学、基因组数据以及样本编码分类的定义2007.11.1 E16 Qualification of Genomic Biomarkers/基因组生物标志物的合格条件 E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions E16:与药物或生物制品研发相关的生物标志物：资质提交材料的背景、结构以及格式2010.8.20 E17 Multi-Regional Clinical Trials/多地区临床试验 E17: General principle on planning and Designing Multi-Regional Clinical Trials E17:计划和设计多地区临床试验的一般性原则2016.5.6 E18 Genomic Sampling/基因组取样 E18: Genomic Sampling and Management of Genomic Data E18：基因组采样和基因组数据管理指导原则(中2015.12.10间文版：征求意见稿)2.4多学科(MultidisciplinaryGuidelines)编号 英文题目中文译文 发布时间M1 MedDRA Terminology 监管活动医学词典 MedDRA Data Retrieval and Presentation: Points to Consider MedDRA 数据检索与呈现： 考虑要点（中文版：征求意见稿） 2017.9.1 MedDRA Term Selection: Points to Consider MedDRA 术语选择： 考虑要点（中文版：征求意见稿）2017.9.1 M2 Electronic Standards 电子标准 ICH M2 EWG Work Plan M2专家工作组工作计划2017.3.27 M2: ElectronicStandards for the Transfer of Regulatory Information Final Concept PaperM2监管信息转移的电子标准终版概念文件1994.10.27 ElectronicTransmission of Individual Case Safety Reports Message Specification个例病例安全性报告的电子传输信息规范 2000.11.9 ICH M2 EWG The eCTDBackbone File Specification for Study Tagging FileseCTD 研究标签文件主文件规范2008.6.3 Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) General Recommendation -Procedure监管信息转移的电子标准一般性建议—程序 2015.6.11 Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation – ESTRI 监管信息转移的电子标准一般性建议—ESTRI 网关 2015.6.11Gateway Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF监管信息转移的电子标准文件格式建议—PDF2011.4.5Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML监管信息转移的电子标准文件格式建议—XML2005.11.10 Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF/A监管信息转移的电子标准文件格式建议—PDF/A2014.6.2Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Format Recommendation – DOCX监管信息转移的电子标准文件格式建议—DOCX2015.6.11Electronic Standardsfor the Transfer ofRegulatory Information (ESTRI) Controlled Vocabularies Recommendation -Genericode监管信息转移的电子标准控制词汇建议—代码2015.6.11Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) Information Transfer Recommendation – EDIINT AS1/AS2监管信息转移的电子标准信息转移建议—EDIINT AS1/AS22010.6.10Electronic Standardsfor the Transfer of Regulatory Information (ESTRI) File Integrity – MD5监管信息转移的电子标准文件完整性—MD52010.6.10Electronic Standards for the Transfer of 监管信息转移的电子标准文件完2015.6.11Regulatory Informaation (ESTRI) File IntegrityRecommendation - SHA-256整性建议—SHA-256M2 Glossary of Terms and Abbreviations M2术语和简写词汇表2015.6.11 ICH M2 File Format Criteria M2文件格式标准 2014.11.10Use of OIDs & UUIDs in ICH Messages OIDs & UUIDs 在ICH 信息中的使用2015.6.11 M3 Nonclinical Safety Studies 非临床研究 M3(R2) Questions and Answers (R2)M3(R2)问答 (R2) 2012.3.5 M3(R2): Guidance onNonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsM3(R2):关于实施药物人体临床试验以及上市批准非临床安全性研究的指导原则2009.6.11M4 : The Common Technical Document 通用技术文件 M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human UseM4（R4）：人用药物注册通用技术文档的组织（中文版：征求意见稿） 2016.6.15 M4 Implementation Working Group Questions & Answers (R3) M4执行工作组问答（R3）（中文版：征求意见稿） 2004.6.10 The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality – M4Q(R1)M4Q （R1）：人用药物注册通用技术文档：药学部分（中文版：征求意见稿） 2002.9.12 M4Q Implementation Working Group Questions & Answers (R1) M4Q 执行工作组问答（R1）（中文版：征求意见稿）2003.7.17 The Common Technical Document for the M4S （R2）：人用药物注册通用技2002.12.2Registration of Pharmaceuticals for Human Use: Safety – M4S(R2)术文档：安全性部分（中文版：征求意见稿）M4S Implementation Working Group Questions & Answers (R4) M4S 执行工作组问答 （R4）（中文版：征求意见稿）2003.11.11 Efficacy- M4E(R2) M4E （R2）：人用药物注册通用技术文档：有效性部分（中文版：征求意见稿）2016.6.15M4E Implementation Working Group Questions & Answers (R4) M4E 执行工作组问答（R4）（中文版：征求意见稿）2004.6.10 M5 Data Elements and Standards for Drug Dictionaries 药物词典的数据要素和标准 The Re-development ofthe Standard forE2B(R3) and the Development of Standards for the Identification of Medicinal Products(IDMP)(ICH M5)ICH M5:E2B(R3)标准的再制定及医药产品鉴定标准的制定2010.11.1 ICH E2B(R3)Implementation Working Group ICH E2B(R3) Guideline: Electroni c Transmission of Individual Case Safety Reports (ICSRs) E2B(R3)实施工作组个例病例安全报告的电子传输问答部分 2016.11.10 Appendix I (B) to theImplementation Guide for Electronic Transmission of Individual Case SafetyReports (ICSRs)个例病例安全报告的电子传输实施指南附录 I (B) 2016.11.10 Appendix I (G) to theImplementation Guide for Electronic Transmission of Individual Case Safety个例病例安全报告的电子传输实施指南附录 I (G)2016.11.10Reports (ICSRs) Implementation Guidefor Electronic Transmission of Individual Case Safety Reports(ICSRs)个例病例安全报告的电子传输实施指南 2016.11.10 M6 Gene Therapy 基因治疗 Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and TransmissionM6: 病毒和基因治疗载体的脱落和传播终版概念文件 2009.8.26 General Principles to Address Virus and Vector Shedding 解决病毒和基因治疗载体脱落的基本原则 2009.6An inventory of shedding data from clinical gene therapy trials临床基因疗法试验脱落数据目录2007.7.30 Final Business Plan M6: Guideline on Virus and Gene Therapy Vector Shedding and TransmissionM6: 病毒和基因治疗载体的脱落和传播终版业务计划 2009.8.27 M7 Genotoxic Impurities 遗传毒性杂质 M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk M7：评估和控制药物中的DNA 活性（致突变）杂质以限制潜在的致癌风险 2014.6.23 M7(R1): Addendum to M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic RiskM7(R1)： 评估和控制药物中 DNA 反应性（致突变）杂质以限制潜在的致癌风险（中文版：征求意见稿） 2017.3.31 M8 Electronic Common Technical Document (eCTD) 电子通用技术文件 Electronic Common Technical Document Specification V3.2.2电子通用技术文件规范 V3.2.2 2008.7.16 M8 : Electronic Common M 8: 电子通用2015.12.9Technical Document Concept Paper 技术文件概念文件ICH M8 EWG/IWG Work Plan M8: 电子通用技术文件工作计划2017.3.13 Support Documentation for M8: eCTD EWG eCTD v4.0 Implementation Package v1.2 M8：eCTD 专家工作组eCTD v4.0实施包 v1.2 支持性证明文件2016.11 Orientation Material forM8: eCTD EWG eCTD v4.0 Implementation Package v1.2 M8：eCTD 专家工作组eCTD v4.0实施包 v1.2 培训材料2016.11 ICH Electronic CommonTechnical Document (eCTD) v4.0 Implementation Guidev1.2ICH eCTD v4.0 实施指南 v1.2 2016.11.10 eCTD v4.0 Implementation Package v1.2eCTD v4.0 实施包 v1.2 USFDA eCTD v4.0 Implementation Package History v1.1 美国FDA eCTDv4.0 实施包历史 v1.1USFDA Module 1Electronic Common Technical Document (eCTD) v4.0 ImplementationGuide v1.1美国FDA 模块1 eCTD v4.0 实施指南 v1.1 2017.2.20 ICH eCTD v4.0 Requirements ICH eCTD v4.0 要求ICH M8 Expert WorkingGroup Specification for Submission Formats for eCTDeCTD 提交格式规范 2016.11.1Change Control Process for the eCTD eCTD 变更控制过程2017.4 Request for change 请求变更表M9 Biopharmaceutic s Classification System-based M9: Biopharmaceutics Classification System-based Biowaivers Final M9：基于生物药剂学分类系统的生物豁免业务计2016.10.7Biowaivers 基于生物药剂学分类系统的生物豁免 endorsed Business Plan划ICH M9 EWG Work Plan M9 专家工作组工作计划2017.2.9 M9: Biopharmaceutics Classification System-based Biowaivers Final endorsed Concept PaperM9：基于生物药剂学分类系统的生物豁免概念文件 2016.10.7 M10 Bioanalytical Method Validation 生物样品分析的方法验证 M10: Bioanalytical Method Validation Final endorsed Business Plan M10: 生物样品分析的方法验证业务计划 2016.10.7ICH M10 EWG Work Plan M10: 专家工作组工作计划 2017.3.10 M10: Bioanalytical Method Validation Final endorsed Concept Paper M10: 生物样品分析的方法验证概念文件2016.10.7文章来源：龙腾整理。
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FORHUMAN USE人用药品的注册要求ICH HARMONISED TRIPARTITE GUIDELINEICH协调的三方指导原则VALIDATION OF ANALYTICAL PROCEDURES: TEXT ANDMETHODOLOGY分析方法验证：正文和方法学Q2(R1)Current Step 4 version现行第4阶段版本Parent Guideline dated 27 October 1994最初指导原则起于1994年10月27日(Complementary Guideline on Methodology dated 6 November 1996incorporated in November 2005)（方法学补充指导原则完成于1996年11月6日，于2005年11月合并）This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.此指导原则由适当的ICH专家工作组起草，经调整团磋商，于ICH过程一致。
在第四阶段，最终的草案推荐给欧盟，日本和美国的监管机构采用。
Q2(R1) Document Historydeveloped to complement the Parent GuidelineTEXT ON VALIDATION OF ANALYTICAL PROCEDURES分析方法验证文件ICH Harmonised Tripartite GuidelineICH协调三方指导原则Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 27 October 1994, this guideline is recommendedfor adoption tothe three regulatory parties to ICH1994年10月27日的ICH策划委员会会议已经进入了ICH进程的第4阶段，此指导原则推荐给ICH三个监管部门采纳1. IntroductionThis document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the EC, Japan and USA.1．介绍作为递交给欧共体，日本和美国新药注册申请资料的一部分，对分析方法验证需考虑事项的特征的讨论在此文件呈现出来。
国际人用药品技术协调会ICH协调指导原则分析方法验证Q2草案2022年3月24日签署目前公开征求意见在ICH进程的第2阶段， ICH大会将由ICH专家工作组认可的共识草案文本或指导原则按照国家或地区程序交给ICH区域的监管机构进行内部和外部征求意见。
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ICH协调指导原则分析方法验证Q2ICH共识指导原则目录1引言 (1)2范围 (2)3分析方法验证研究 (2)3.1分析方法生命周期中的验证 (4)3.2可报告范围 (5)3.3稳定性指示特性的证明 (6)3.4多变量分析方法的考虑 (6)3.4.1参比分析方法 (6)4验证试验、方法学和评价 (7)4.1专属性/选择性 (7)4.1.1无干扰 (7)4.1.2正交方法比较 (7)4.1.3技术固有合理性 (7)4.1.4数据要求 (8)4.1.4.1鉴别 (8)4.1.4.2含量测定、纯度和杂质检查 (8)4.2工作范围 (9)4.2.1响应 (9)4.2.1.1线性响应 (9)4.2.1.2非线性响应 (10)4.2.1.3多变量校正 (10)4.2.2范围下限验证 (10)4.2.2.1根据信噪比 (10)4.2.2.2根据线性响应值的标准偏差和标准曲线斜率 (11)4.2.2.3根据范围下限的准确度和精密度 (12)i4.2.2.4数据要求 (12)4.3准确度和精密度 (12)4.3.1准确度 (12)4.3.1.1参比物比较 (13)4.3.1.2加标研究 (13)4.3.1.3正交方法比较 (13)4.3.1.4数据要求 (13)4.3.2精密度 (14)4.3.2.1重复性 (14)4.3.2.2中间精密度 (14)4.3.2.3重现性 (14)4.3.2.4数据要求 (14)4.3.3准确度和精密度的合并评价方式 (15)4.3.3.1数据要求 (15)4.4耐用性 (15)5术语 (16)6参考文献 (24)7附件1验证试验选择 (24)8附件2分析技术例证 (25)ii1引言12本指导原则是讨论药物在ICH成员监管机构注册申请时，递交的分析方法验证所3需考虑的要素。
ICH指导原则为了严格管理药品,必须对药品的研制、开发、生产、销售、进品等进行审批，形成了药品的注册制度。
但是不同国家对药品注册要求各不相同，这不仅不利于病人在药品的安全性、有效性和质量方面得到科学的保证及国际技术和贸易交流，同时也造成制药工业和科研、生产部门人力、物力的浪费，不利于人类医药事业的发展。
因此，由美国、日本和欧盟三方的政府药品注册部门和制药行业在1990年发起的ICH（人用药物注册技术要求国际协调会议,International Conference on Harmonization of TechnicalRequirements for Registration of Pharmaceuticals for Human Use）就是这样应运而生的。
ICH的论题主要分为四类，因此ICH根据论题的类别不同而进行相应的编码分类：1. “Q”类论题：Q代表QUALITY，指那些与化工和医药，质量保证方面的相关的论题。
2. “S”类论题：S代表SAFETY，指那些与实验室和动物实验，临床前研究方面的相关的论题。
3. “E”类论题：E代表EFFICACY，指那些与人类临床研究相关的课题。
4. “M”类论题：M代表MULTIDISCIPLINARY, 指那些不可单独划入以上三个分类的交叉涉及的论题。
同时M又细分为5个小类M1: 常用医学名词（MedDRA）M2: 药政信息传递之电子标准M3: 与临床试验相关的临床前研究时间的安排M4: 常规技术文件(CTD)M5: 药物词典的数据要素和标准2005年11月ICH执行委员会接受了一套用于ICH指导原则的新编码法则，并与当月正式执行。
Quality质量：Q1: Stability稳定性Q1A(R2): Stability Testing of New Drug Substances and Products新原料药和制剂的稳定性试验Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新剂型的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data稳定性数据的评估Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2: Analytical Validation分析验证Q2(R1): Validation of Analytical Procedures: Text and Methodology分析程序的验证：正文及方法论Q3: Impurities 杂质Q3A(R2): Impurities in New Drug Substances新原料药中的杂质Q3B(R2): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质Q3C(R3): Impurities: Guideline for Residual Solvents杂质：残留溶剂指南Impurities: Guideline for Residual Solvents (Maintenance) 杂质：残留溶剂指南(保留)PDE for Tetrahydrofuran (in Q3C(R3)) 四氢呋喃的PDEPDE for N-Methylpyrrolidone (in Q3C(R3)) N-甲基吡咯烷酮的PDEQ4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions药典内容的评估及推荐为用于ICH地区Q4B Annex1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regionson Residue on Ignition/Sulphated Ash General Chapter附录1 药典内容的评估及推荐为用于ICH地区关于灼烧残渣/灰分常规篇Q4B Annex2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter 附录2 药典内容的评估及推荐为用于ICH地区关于注射剂可提取容量测试常规篇Q4B Annex3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter 附录3 药典内容的评估及推荐为用于ICH地区关于颗粒污染物测试:不溶性微粒常规篇Q5: Quality of Biotechnological Products 生物技术制品质量Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or AnimalOrigin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used forProduction of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used for Production ofBiotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their ManufacturingProcess基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications 规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including decision trees)质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质(包括决定过程)Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 质量规格：生物技术/生物产品的检验程序和可接收标准Q7: Good Manufacturing Practices （GMP）Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Annex to Q8Q8附录Q9: Quality Risk Management质量风险管理Q10: Pharmaceutical Quality System 药物质量体系。
ICH指导原则-术语ICH指导原则为了严格管理药品,必须对药品的研制、开发、生产、销售、进品等进行审批，形成了药品的注册制度。
但是不同国家对药品注册要求各不相同，这不仅不利于病人在药品的安全性、有效性和质量方面得到科学的保证及国际技术和贸易交流，同时也造成制药工业和科研、生产部门人力、物力的浪费，不利于人类医药事业的发展。
因此，由美国、日本和欧盟三方的政府药品注册部门和制药行业在1990年发起的ICH(人用药物注册技术要求国际协调会议,International Conference on Harmonization of TechnicalRequirements for Registration of Pharmaceuticals for Human Use)就是这样应运而生的。
ICH的论题主要分为四类，因此ICH根据论题的类别不同而进行相应的编码分类:1. “Q”类论题:Q代表QUALITY，指那些与化工和医药，质量保证方面的相关的论题。
2. “S”类论题:S代表SAFETY，指那些与实验室和动物实验，临床前研究方面的相关的论题。
3. “E”类论题:E代表EFFICACY，指那些与人类临床研究相关的课题。
4. “M”类论题:M代表MULTIDISCIPLINARY, 指那些不可单独划入以上三个分类的交叉涉及的论题。
同时M又细分为5个小类M1: 常用医学名词 (MedDRA)M2: 药政信息传递之电子标准M3: 与临床试验相关的临床前研究时间的安排M4: 常规技术文件(CTD)M5: 药物词典的数据要素和标准2005年11月ICH执行委员会接受了一套用于ICH指导原则的新编码法则，并与当月正式执行。
Quality质量:Q1: Stability稳定性Q1A(R2): Stability Testing of New Drug Substances and Products 新原料药和制剂的稳定性试验Q1B: Photostability Testing of New Drug Substances and Products 新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新剂型的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data稳定性数据的评估Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2: Analytical Validation分析验证Q2(R1): Validation of Analytical Procedures: Text and Methodology 分析程序的验证:正文及方法论Q3: Impurities 杂质Q3A(R2): Impurities in New Drug Substances新原料药中的杂质of work enthusiasm and forward-looking. The difficulties and problems of individual cadres indifferent masses as the buck passing, long, make some simple complex problems. Some cadres general talk about pay, do not take the initiative to undertake for the bitter and tired of the work, the lack of courage to play a positive attitude." corrective measures: (LED Leadership: Luo Mingjun, rectification time: before September 25th, insist for a long time) 1, effectively solve the enterprise less, help is not enough. In order to "turn style, solve problems, and do practical things, heart to heart" as the core, in accordance with the provisions of division of Labor Bureau, by the Bureau of Party members and cadres room composition the working group , to help enterprises solve problems, promote the construction of major projects; close ties with the masses, to ask for the people, ask for people to know the people, public opinion, the people, improve people's livelihood.Q3B(R2): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质Q3C(R3): Impurities: Guideline for Residual Solvents杂质:残留溶剂指南Impurities: Guideline for Residual Solvents (Maintenance) 杂质:残留溶剂指南(保留)PDE for Tetrahydrofuran (in Q3C(R3)) 四氢呋喃的PDEPDE for N-Methylpyrrolidone (in Q3C(R3)) N-甲基吡咯烷酮的PDEQ4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Usein the ICH Regions药典内容的评估及推荐为用于ICH地区Q4B Annex1 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regionson Residue on Ignition/Sulphated Ash General Chapter附录1 药典内容的评估及推荐为用于ICH地区关于灼烧残渣/灰分常规篇Q4B Annex2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regionson Test for Extractable Volume of Parenteral Preparations General Chapter附录2 药典内容的评估及推荐为用于ICH地区关于注射剂可提取容量测试常规篇Q4B Annex3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regionson Test for Particulate Contamination: Sub-Visible Particles General Chapter附录3 药典内容的评估及推荐为用于ICH地区关于颗粒污染物测试:不溶性微粒常规篇Q5: Quality of Biotechnological Products 生物技术制品质量Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or AnimalOrigin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used forProduction of r-DNA Derived Protein Products生物技术产品的质量:源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技术产品的质量:生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used for Production ofBiotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their ManufacturingProcess基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications 规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New DrugProducts: Chemical Substances (including decision trees)质量规格:新原料药和新制剂的检验程序和可接收标准:化学物质(包括决定过程)Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格:生物技术/生物产品的检验程序和可接收标准of work enthusiasm and forward-looking. The difficulties and problems of individual cadres indifferent masses as the buck passing, long, make some simple complex problems. Some cadres general talk about pay, do not take the initiative to undertake for the bitter and tired of the work, the lack of courage to play a positive attitude." corrective measures: (LED Leadership: Luo Mingjun, rectification time: before September 25th, insist for a long time) 1, effectively solve the enterprise less, help is not enough. In order to "turn style, solve problems, and do practical things, heart to heart" as the core, in accordance with the provisions of division of Labor Bureau, by the Bureau of Party members and cadres room composition the working group , to help enterprises solve problems, promote the construction of major projects; close ties with the masses, to ask for the people, ask for people to know the people, public opinion, the people, improve people's livelihood.Q7: Good Manufacturing Practices (GMP)Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Annex to Q8Q8附录Q9: Quality Risk Management质量风险管理Q10: Pharmaceutical Quality System 药物质量体系of work enthusiasm and forward-looking. The difficulties and problems of individual cadres indifferent masses as the buck passing, long, make some simple complex problems. Some cadres general talk about pay, do not take the initiative to undertake for the bitter and tired of the work, the lack of courage to play a positive attitude." corrective measures: (LED Leadership: Luo Mingjun, rectification time: before September 25th, insist for a long time) 1, effectively solve the enterprise less, help is not enough. In order to "turn style, solve problems, and do practical things, heart to heart" as the core, in accordance with the provisions of division of Labor Bureau, by the Bureau of Party members and cadres room composition the working group , to help enterprises solve problems, promote the construction of major projects; close ties with the masses, to ask for the people, ask for people to know the people, public opinion, the people, improve people's livelihood.。
