ICH 指导原则文件目录(中英文)

1、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：“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。“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。“E”类论题：E 代表 EFFICACY，指那些与人类临床研究相关的课题。“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:

2、 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

3、Dosage Forms 新剂型的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances a nd 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:

4、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

5、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Q4: Pharmacopoeias 药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for U

6、se in the IC H 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 i n 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 i n

7、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 i n the ICH Regionson Test for Particulate Contamination: Sub-Visible Particles General Chapter附录

8、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 Lin es 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 Constr

9、uct i n 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/B iological 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 Characterization of Cell Substrates Used for

10、Production of Bi otechnological/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 inTheir 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 Dr

11、ug Subst ances 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 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 Manufa

12、cturing 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药物质量体系二、ICH.安全性部分(Safety) 致癌试验S1A Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals 药物致癌试

13、验的必要性S1B Testing for Carcinogenicity of Pharmaceuticals 药物致癌试验S1C(R2)Dose Selection for Carcinogenicity Studies of Pharmaceuticals 药物致癌试验的剂量选择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

14、导原则S2A 药物审评遗传毒性试验的特殊性指导原则S2B 遗传毒性：药物遗传毒性试验标准组合药代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S4 Duration of Chronic Toxicity

15、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 )S5A 药品的生殖毒性检测S5B 雄

16、性生育力毒性其他S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 生物技术药品的临床前安全性试验S7A Safety Pharmacology Studies for Human Pharmaceuticals人用药物的安全性药理研究S7B The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceut

17、icals 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 Immunotoxicity Studies for Human Pharmaceuticals 人类药品的免疫毒性研究S9 Nonclinical Evaluation for Anticancer Pharmaceuticals 抗癌药物的临床前评价S10 Photosafety Evaluation三、ICH.临床部分(Efficacy)E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for

18、 Long-Term Treatment of Non-Life-Threatening Conditions 评价临床长期给药方案的安全性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-Approv

19、al 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E2F Development Safety Update ReportE3 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

20、所需量-效关系的资料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(R1) Good Clinical Practice: Consolidated Guideline 药品临床研究规范（GCP） 一致性指导原则E7 Studies in Support of Special Populations: Geriatrics 老年人群的临床研究E8 General Considerations for Clinical Trials临床试验的一般考虑E9 Stati

21、stical Principles for Clinical Trials临床试验统计原则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E12 按治疗分类的各类药物临床评价E12 Principles for Clinical Evaluation of New Antihypertensive DrugsE14 The

22、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 for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding CategoriesE16 Biomarkers Related to Drug or Biotec

23、hnology Product Development: Context,Structure and Format of Qualification Submissions四、ICH.综合部分 (Multidisciplinary)M1 医学术语 Med DRAM2 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M3 Guidance on N

24、onclinical 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 Gran