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。
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
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 Substancesand 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 IIIand 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PDE
PDE for N-Methylpyrrolidone (in Q3C(R3)) N-甲基吡咯烷酮的PDE
Q4: Pharmacopoeias药典
Q4A: Pharmacopoeial Harmonisation 药典的协调
Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICHRegions
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 theICH Regions on 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 theICH Regions on Test for Extractable Volume of Parenteral Preparations GeneralChapter
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 theICH Regions on Test for Particulate Contamination: Sub-Visible ParticlesGeneral 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 CellLines 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 Constructin 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 ofBiotechnological/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 Changesin 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 DrugSubstances and New Drug Products: Chemical Substances (including decisiontrees)
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 forBiotechnological/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 Q8 Q8附录
Q9: Quality Risk Management质量风险管理
Q10: Pharmaceutical Quality System 药物质量体系
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 forPharmaceuticals
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 Exposurein 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 DoseToxicity Tests
单剂量毒性检验
S4A: Duration ofChronic 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 tothe 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 VentricularRepolarization
(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
EFFICACY 药效
E1: The Extentof Population Exposure to Assess Clinical Safety for Drugs Intended forLong-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 ExpeditedReporting
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 ManagementData 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: DataElements 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 Questionsand 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 forMarketed 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 Drugs
E2C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 forExpedited 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 Guideline
GCP：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 ProarrhythmicPotential 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: MedicalTerminology
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 theguidelines)
通用技术文件（见有关CTD章节） M5: DataElements and Standards for Drug Dictionaries
药物词典的数据要素和标准
M3(M):Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conductof 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
