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。Q1/Q2...Q10都属于这类。
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。
Q1: Stability稳定性
1. Q1A(R2): Stability Testing of New Drug Substances and Products
新原料药和制剂的稳定性试验
2. Q1B: Photostability Testing of New Drug Substances and Products
新原料药和制剂的光稳定性试验
3. Q1C: Stability Testing for New Dosage Forms
新剂型的稳定性试验
4. 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
5. Q1E: Evaluation of Stability Data
稳定性数据的评估
6. 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
7. Q2(R1): Validation of Analytical Procedures: Text and Methodology
分析程序的验证：正文及方法论
Q3A - Q3D: Impurities 杂质
8. Q3A(R2): Impurities in New Drug Substances
新原料药中的杂质
9. Q3B(R2): Impurities in New Drug Products (Revised Guideline)
新制剂中的杂质
10. Q3C(R5): Impurities: Guideline for Residual Solvents
杂质：残留溶剂指南
11. Q3C(R6): Impurities: Guideline for Residual Solvents
PDE for Triethylamine and PDE for Methylisobutylketone
杂质：残留溶剂指南
三乙胺的日允许接触剂量及甲基异丁基酮的日允许接触剂量
1. Q3D: Guideline for Elemental impurities
主要杂质指南
Q4 - Q4B: Pharmacopoeias药典
2. Q4A: Pharmacopoeial Harmonisation 药典的协调
3. Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH地区使用的药典正文评估和建议
4. Q4B Annex1(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
附录1 ICH地区使用的药典正文评估和建议
灼烧残渣/灰分 通则
5. Q4B Annex2(R1) 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 ICH地区使用的药典正文评估和建议
注射剂可提取体积测试 通则
6. Q4B Annex3(R1) 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 地区使用的药典正文评估和建议
颗粒污染物测试:不溶性微粒 通则
7. Q4B ANNEX 4A(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-sterile Products：Microbial Enumerations Tests General Chapter
附录4A(R1) 地区使用的药典正文评估和建议
非无菌产品微生物检验:微生物计数法 通则
8. Q4B ANNEX 4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-sterile Products：Test for Specified Micro-organisms General Chapter
附录4B(R1) 地区使用的药典正文评估和建议
非无菌产品微生物检验:控制菌检查法 通则
9. Q4B ANNEX 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-sterile Products：Acceptance Criteria For Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
附录4C(R1) 地区使用的药典正文评估和建议
非无菌产品微生物检验:药物制剂及原料药的认可标准 通则
1. Q4B ANNEX 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter
附录5(R1) ICH地区使用的药典正文评估和建议
崩解试验 通则
2. Q4B ANNEX 6 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of dosage units General Chapter
附录6 ICH地区使用的药典正文评估和建议
含量均匀度 通则
3. Q4B ANNEX 7(R2) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter
附录7(R2) ICH地区使用的药典正文评估和建议
溶解度测试 通则
4. Q4B ANNEX 8(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter
附录8(R1) ICH地区使用的药典正文评估和建议
无菌检查 通则
5. Q4B ANNEX 9(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter
附录9(R1) ICH地区使用的药典正文评估和建议
片剂脆碎度检查 通则
6. Q4B ANNEX 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter
附录10(R1) ICH地区使用的药典正文评估和建议
聚丙烯酰胺凝胶电泳 通则
7. Q4B ANNEX 11 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter
附录11 ICH地区使用的药典正文评估和建议
毛细管电泳 通则
8. Q4B ANNEX 12 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter
附录12 ICH地区使用的药典正文评估和建议
分析筛选 通则
9. Q4B ANNEX 13 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders General Chapter
附录13 ICH地区使用的药典正文评估和建议
粉末的松密度与紧密度
1. Q4B ANNEX 14 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter
附录14 ICH地区使用的药典正文评估和建议
细菌内毒素检测 通则
Q5A - Q5E: Quality of Biotechnological Products 生物技术制品质量
2. 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
3. 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：rDNA衍生蛋白质产品生产细胞的表达构建体分析
4. Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
生物技术产品的质量：生物技术产品/生物制品的稳定性试验
5. Q5D: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
用于生产生物技术产品/生物制品的细胞基质的来源和鉴定
6. Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
生产工艺变更后生物技术产品/生物制品的可比性
Q6A- Q6B: Specifications
质量标准
7. Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including decision trees)
规范：新原料药和新制剂的检测方法和可接收标准：化学物质(包括决定过程)
8. Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
规范：生物技术产品/生物制品的检验方法和可接收标准
Q7: Good Manufacturing Practices （GMP）良好的生产质量管理规范
9. Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
药物活性成份的GMP指南
Q8: Pharmaceutical Development 药物开发
10. Q8(R2): Pharmaceutical Development
药物开发
Q9: Quality Risk Management 质量风险管理
11. Q9: Quality Risk Management
质量风险管理
Q10: Pharmaceutical Quality System 药物质量体系
1. Q10: Pharmaceutical Quality System
药物质量体系
Q11：Development and Manufacture of Drug Substances 原料药的开发与制造
2. Q11:Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
原料药的开发与制造（化学实体与生物技术/生物制品实体）
S1A - S1C: Carcinogenicity Studies致癌试验
1. S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
药物致癌试验的必要性
2. S1B: Testing for Carcinogenicity of Pharmaceuticals
药物致癌试验
3. S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals
药物致癌试验的剂量选择
S2 Genotoxicity Studies遗传毒性
4. S2(R1) : Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
人用药物的遗传毒性试验和数据分析指导原则
S3A - S3B: Toxicokinetics and Pharmacokinetics毒物代谢动力学与药物代谢动力学
5. 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：毒性研究中全身暴露的评价
6. S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
药物代谢动力学：重复给药的组织分布研究指导原则
S4: Toxicity Testing毒性试验
7. S4: 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（啮齿类和非啮齿类毒性试验）
S5: Reproductive Toxicology生殖毒性
8. S5(R2) : Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility
药品的生殖毒性检测及雄性生育力毒性
S6: Biotechnological Products生物技术产品
9. S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
生物技术药品的临床前安全性试验
S7A - S7B: Pharmacology Studies 药理学研究
1. S7A: Safety Pharmacology Studies for Human Pharmaceuticals
人用药物的安全性药理研究
2. S7B: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals人用药延迟心室复极化（QT间期延长）潜在作用的非临床评价指导原则
S8: Immunotoxicology Studies 免疫毒理学研究
3. S8: Immunotoxicity Studies for Human Pharmaceuticals
人用药品的免疫毒理学研究
S9: Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药物临床前评价
4. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
抗癌药物的临床前评价
S10: Photosafety Evaluation 光安全评价
5. S10: Photosafety Evaluation of Pharmaceuticals
药物的光安全评价
E1: Clinical Safety for Drugs used in Long-Term Treatment长期治疗药物的临床安全性
1. E1: 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 - E2F: Pharmacovigilance药物警戒
2. E2A: Definitions and Standards for Expedited Reporting
快速报告的定义和标准
3. E2C(R2): Periodic Benefit-Risk Evaluation Report
上市药品定期风险效益评估报告
4. E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting批准后安全性数据管理：快速报告的定义和标准
5. E2E: Pharmacovigilance Planning药物警戒计划
6. E2F: Development Safety Update Report 安全性更新报告
E3: Clinical Study Reports 临床研究报告
7. E3: Structure and Content of Clinical Study Reports
临床研究报告的结构与内容
E4: Dose-Response Studies 量效研究
8. E4: Dose-Response Information to Support Drug Registration
新药注册所需量-效关系的资料
E5: Ethnic Factors 种族因素
9. E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data
对国外临床研究资料的种族因素的可接受性
E6: Good Clinical Practice药品临床研究规范
1. E6(R1): Good Clinical Practice: Consolidated Guideline
药品临床研究规范（GCP）一致性指导原则
2. E6(R2): Integrated Addendum to ich E6(R1): Guideline for Good Clinical Practice E6(R1)整合的附录：药品临床研究规范指南
E7: Clinical Trials in Geriatric Population 老年人群的临床研究
3. E7: Studies in Support of Special Populations: Geriatrics
老年人群的临床研究
E8: General Considerations for Clinical Trials 临床研究总则
4. E8: General Considerations for Clinical Trials
临床研究总则
E9: Statistical Principles for Clinical Trials 临床研究的统计原则
5. E9: Statistical Principles for Clinical Trials
临床研究统计原则
E10: Choice of Control Group in Clinical Trials 临床研究对照组的选择
6. E10: Choice of Control Group and Related Issues in Clinical Trials
临床研究对照组的选择及相关问题
E11: Clinical Trials in Pediatric Population 儿童人群的临床研究
7. E11: Clinical Investigation of Medicinal Products in the Pediatric Population
儿童人群的临床研究
E12: Clinical Evaluation by Therapeutic Category 按治疗分类的各类药物临床评价
8. E12: Principles for Clinical Evaluation of New Antihypertensive Drugs
抗高血压新药的临床评价指导原则
E14: Clinical Evaluation of QT QT临床评价
9. E14: 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
E15: Definitions in Pharmacogenetics / Pharmacogenomics 遗传药理学/药物基因组学的定义
10. E15: 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: Qualification of Genomic Biomarkers 基因生物标记物的条件
11. E16: 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: Multi-Regional Clinical Trials多个地区临床试验
21. E17: General principle on planning/designing Multi-Regional Clinical Trials
规划多地区临床试验的一般原则
E18: Genomic Sampling 基因组抽样
22. E18: Guideline on Genomic Sampling and Management of Genomic Data
基因组数据采集与管理的指导原则
ICH.综合部分 (Multidisciplinary)
M1: MedDRA Terminology 医学术语
M2: Electronic Standards 电子标准
M3: Nonclinical Safety Studies临床前安全性研究
1. M3: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
药物进行人体临床试验和上市许可申请的临床前安全性研究指导原则
M4: Common Technical Document 通用技术文件
2. M4(R3): Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
人用药物注册申请的通用技术文件组织结构
3. M4E(R1): The Common Technical Document for Registration of Pharmaceuticals for Human Use Clinical
人用药物注册申请的通用技术文件：临床
4. M4E(R2): Revision of M4E Guideline on Enhancing Format and Structure of Benefit-risk Information in ICH Efficacy
M4E指南修订，优化临床研究风险评估的格式与结构
5. M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
人用药物注册申请的通用技术文件：质量
6. M4S(R2): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety
人用药物注册申请的通用技术文件：安全性
7. M4E(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy
人用药物注册申请的通用技术文件：有效性
M5: Data Elements and Standards for Drug Dictionaries药品词汇的数据要素和标准
M6: Gene Therapy 基因疗法
M7: Genotoxic Impurities 基因毒性杂质
8. M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和制
M8: Electronic Common Technical Document (eCTD) 电子通用技术文件
