ICH-指导原则文件目录

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：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/Q2Q10都属于这类。2. “瓷论题：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。1、 ICH. 质量部分( Quality )Q1:

2、 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 S

3、ubstances 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 Meth

4、odology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 SolventsPDE for Tri

5、ethylamine 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12. Q3D: Guideline for Elemental impurities 主要杂质指南Q4 - Q4B: Pharmacopoeias 药典13. Q4A: Pharmacopoeial Harmonisation 药典的协调14. Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH RegionsICH 地区使用的药典正

6、文评估和建议15. 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16. Q4B Annex2(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test

7、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17. 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

8、物测试:不溶性微粒通则18. 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19. Q4B ANNEX 4B(R1) Evaluation and Recommen

9、dation 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20. Q4B ANNEX 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH

10、 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21. Q4B ANNEX 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Us

11、e 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22. 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23. Q4B ANNEX 7(R2) Evaluation an

12、d 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24. 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

13、议 无菌检查 通则25. 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26. Q4B ANNEX 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylam

14、ide 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27. 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28. Q4B ANNEX 12 Evaluation and Recommendation

15、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29. 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

16、评估和建议粉末的松密度与紧密度30. 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31. Q5A(R1): Viral Safety Evaluation of Biotechnology

17、 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32. 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33. Q5C: Quality of Biotechnologic

18、al 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34. 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35. Q5E: Comparability of Biotechnological/Biological Pr

19、oducts 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36. 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

20、过程)37. 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38. Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 药物活性成份的 GMP 指南Q8: Pharmaceutical

21、Development 药物开发39. Q8(R2): Pharmaceutical Development药物开发Q9: Quality Risk Management 质量风险管理40. Q9: Quality Risk Management质量风险管理Q10: Pharmaceutical Quality System 药物质量体系41. 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42. Q11:Development and M

22、anufacture 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)2、 ICH. 安全性部分(Safety)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 Carcinogenicit

23、y 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

24、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: Duratio

25、n 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.

26、 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10. S7A: Safety Pharmacology Studies for Human Pharmaceuticals 人用药物的安全性药理研究11. S7B: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT I

27、nterval Prolongation) by Human Pharmaceutical以用药延 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12. 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13. S9: Nonclinical Evaluation for Anticancer Pha

28、rmaceuticals 抗癌药物的临床前评价S10: Photosafety Evaluation 光安全评价14. S10: Photosafety Evaluation of Pharmaceuticals 药物的光安全评价3、 ICH. 临床部分 (Efficacy)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 Lo

29、ng-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: De

30、finitions 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-Res

31、ponse 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10. E6(R1): Good Clinical Practice: Consolidated Guideline药品临床研究规范(GCP) 一致性指导原则11. E6(R2):

32、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12. 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13. E8: General Considerations

33、 for Clinical Trials临床研究总则E9: Statistical Principles for Clinical Trials 临床研究的统计原则14. 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15. 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 Tri

34、als in Pediatric Population 儿童人群的临床研究16. 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17. 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 Evaluati

35、on of QT QT 临床评价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E15: Definitions in Pharmacogenetics / Pharmacogenomics 遗传药理学 /药物基因组学的定义19. E15: Definitions for Genomic Biomarkers, Pharmacogeno

36、mics, 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20. 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

37、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4、 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 Stu