ICH 指导原则文件目录(中英文)

人用药品注册技术要求国际协调会（ICH）文件目录

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。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。同时M又细分为5个小类 ：

M1: 常用医学名词 （Med DRA）

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

一、ICH. 质量部分（Quality） 稳定性

1. Quality质量

2. Q1: Stability稳定性

3. Q1A(R2): Stability Testing of New Drug Substances and Products 新原料药

和制剂的稳定性试验

4. Q1B: Photostability Testing of New Drug Substances and Products 新原料药

和制剂的光稳定性试验

5. Q1C: Stability Testing for New Dosage Forms 新剂型的稳定性试验

6. Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substa

nces 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

7. 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

8. Q2: Analytical Validation分析验证

9. Q2(R1): Validation of Analytical Procedures: Text and Methodology

分析程序的验证：正文及方法论

10. Q3: Impurities 杂质

11. Q3A(R2): Impurities in New Drug Substances 新原料药中的杂质

12. Q3B(R2): Impurities in New Drug Products (Revised Guideline) 新制剂中

的杂质

13. 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)) 四氢呋喃的日允许接触剂量

PDE for N-Methylpyrrolidone (in Q3C(R3)) N-甲基吡咯烷酮的日允许接触剂

量

14. Q4: Pharmacopoeias药典

15. Q4A: Pharmacopoeial Harmonisation 药典的协调

16. 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

17. Q4B Annex1 Evaluation and Recommendation of Pharmacopoeial Texts

for Use in the ICH 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

18. 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

19. 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

20. Q5: Quality of Biotechnological Products 生物技术制品质量

21. Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived fro

m 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

22. Q5B: Quality of Biotechnological Products: Analysis of the Expression Co

nstruct 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

23. Q5C: Quality of Biotechnological Products: Stability Testing of Biotechno

logical/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

24. Q5D: Derivation and Characterization of Cell Substrates Used for Produc

tion 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

25. Q5E: Comparability of Biotechnological/Biological Products Subject to C

hanges 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

26. Q6: Specifications

规格

27. Q6A: Specifications: Test Procedures and Acceptance Criteria for New Dr

ug 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)

28. Q6B: Specifications: Test Procedures and Acceptance Criteria for

29. 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

30. Q7: Good Manufacturing Practices （GMP）

31. Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ing

redients 活性药物成份的GMP指南

32. Q8: Pharmaceutical Development

药物研发

33. Annex to Q8

Q8附录

34. Q9: Quality Risk Management

质量风险管理

35. Q10: Pharmaceutical Quality System

药物质量体系

二、ICH.安全性部分(Safety) 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

4. S1C’ 药物致癌试验的剂量选择的附件：补充剂量限度和有关注释 遗传毒性

5. 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

6. S2A药物审评遗传毒性试验的特殊性指导原则

7. S2B遗传毒性：药物遗传毒性试验标准组合 药代

8. S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic

Exposure in Toxicity Studies 毒代动力学指导原则：毒性研究中全身暴露的评价

9. S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution

Studies 药代动力学：重复给药的组织分布研究指导原则 慢性毒性

10. S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non

Rodent Toxicity Testing) 动物慢性毒性试验的周期（啮齿类和非啮齿类） 生殖毒性

11. S5(R2) Detection of Toxicity to Reproduction for Medicinal Products

and Toxicity to Male Fertility (the Addendum dated November 1995 has been

incorporated into the core guideline in November 2005 )

12. S5A药品的生殖毒性检测

13. S5B雄性生育力毒性 其他

14. S6 Preclinical Safety Evaluation of Biotechnology-Derived

Pharmaceuticals 生物技术药品的临床前安全性试验

15. S7A Safety Pharmacology Studies for Human Pharmaceuticals 人用药物

的安全性药理研究

16. 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

17. S8 Immunotoxicity Studies for Human Pharmaceuticals人类药品的免疫毒

性研究

18. S9 Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药物的临床

前评价

19. S10 Photosafety Evaluation

三、ICH.临床部分(Efficacy)

1.E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs

Intended for Long-Term Treatment of Non-Life-Threatening Conditions 评价临床

长期给药方案 的安全性

2.E2A Definitions and Standards for Expedited Reporting 快速报告的定义和标

准

3.E2B(R3) Data Elements for Transmission of Individual Case Safety Reports个

体病例安全性报告传递的数据要素

4.E2C Periodic Benefit-Risk Evaluation Report 上市药品定期安全性更新报告

5.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

6.E2E Pharmacovigilance Planning药物警戒计划

7. E2F Development Safety Update Report

8.E3 Structure and Content of Clinical Study Reports 临床研究报告的结构与内

容

9.E4 Dose-Response Information to Support Drug Registration 新药注册所需量

-效关系的资料

10.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

11.E6(R1) Good Clinical Practice: Consolidated Guideline 药品临床研究规范

（GCP）一致性指导原则

12.E7 Studies in Support of Special Populations: Geriatrics 老年人群的临床研究

13.E8 General Considerations for Clinical Trials 临床试验的一般考虑

14.E9 Statistical Principles for Clinical Trials 临床试验统计原则

15.E10 Choice of Control Group and Related Issues in Clinical Trials 对照组的

选择

16.E11 Clinical Investigation of Medicinal Products in the Pediatric Population

儿童人群的临床研究

17.E12按治疗分类的各类药物临床评价

E12 Principles for Clinical Evaluation of New Antihypertensive Drugs

18.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

19.E15 Definitions for Genomic Biomarkers, Pharmacogenomics,

Pharmacogenetics, Genomic Data and Sample Coding Categories

20.E16 Biomarkers Related to Drug or Biotechnology Product Development:

Context, Structure and Format of Qualification Submissions

四、ICH.综合部分 (Multidisciplinary)

1. M1医学术语Med DRA

2. M2 Electronic Transmission of Individual Case Safety Reports Message

Specification (ICH ICSR DTD Version 2.1) companion document to E2B(R3)

注册资料传递所需的电子代码

3. M3 Guidance on Nonclinical Safety Studies for the Conduct of Human

Clinical Trials and Marketing Authorization for Pharmaceuticals

与临床研究有关的临床前研究的时间安排

4. M4 Organisation of the Common Technical Document for the Registration

of Pharmaceuticals for Human Use (Edited with Numbering and Section Header

Changes, September 2002). Including the Annex : the Granularity Document

(Revised November 2003).

CTD（common technical document）（包括CTD、CTD-Q、CTD-S、CTD-E和eCTD）

药品词汇的数据要素和标准

5. M4Q (R1) The Common Technical Document for the Registration of

Pharmaceuticals for Human Use: Quality (Edited with Numbering and Section

Header Changes, September 2002)

6. M4S (R2) The Common Technical Document for the Registration of

Pharmaceuticals for Human Use: Safety (Edited with Numbering and Section

Header Changes, September 2002)

7. M4E (R1) The Common Technical Document for the Registration of

Pharmaceuticals for Human Use: Efficacy (Edited with Numbering and Section

Header Changes, September 2002)

8. M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in

Pharmaceuticals to Limit Potential Carcinogenic Risk

Reference:

1. 《ICH 药品注册的国际要求》

2.

3. /health/Health/yx/yao/2007-08-07/