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 . ”1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 .“熨论题：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 .“关论题：E代表EFFICACY ,指那些与人类临床研究相关的课题。4.“限论题：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。一、ICH.质量部分(Quality )Q1: Stability 稳定性1. Q

2、1A(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

3、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Q3

4、A - 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 Triethylamine and PDE for

5、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地区使用的药典正文评估和建议15. Q4B Annex1(R1) E

6、valuation 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 for Extractable Vlume of Par

7、enteral 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: Su-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18. Q4B ANNEX 4A(R1) E

8、valuation 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 Recommendation of Pharmacopoeial Texts fo

9、r 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 Regions on Microbiological Exami

10、nation 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 Use in the ICH Regions on Disintegrat

11、ion 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 and Recommendation of Pharmacopoeial Text

12、s 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议 无菌检查通则25. Q4B ANNEX 9(R1) Evaluation and Re

13、commendation 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 Polyacrylamide Gel Electrophoresis General Chapter附录10(R1) I

14、CH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111cH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 of Pharmacopoeial Texts for Use in the ICH Regions on A

15、nalytical 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评估和建议粉末的松密度与紧密度30. Q4B ANNEX 14 Evaluation and Recommendation

16、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 Products Derived from Cell Lines of Human or Animal Origin来源于人或者

17、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 Biotechnological Products: Stability Testing of Biotechnological/Biological Produ

18、cts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 Products Subject to Changes in Their Manufacturing Process生产工艺变更后生物技术产品

19、/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(包括决定过程)37. Q6B: Specifications: Test Procedures and Acceptance Criteria for B

20、iotechnological/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 Development 药物开发39. Q8(R2): Pharmaceutical Development药物开发Q9: Quality Risk Mana

21、gement 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 Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biologica

22、l 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)二、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 Carcinogenicity of Pharmaceuticals药物致癌试验3. S1C(R2): Dose Selection for Carcinogenicity Studies of

23、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 As

24、sessment 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54: Toxicity Testing 毒性试验7. S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)动物体

25、内慢性毒性持续时间的检验(啮齿类和非啮齿类毒性试验)55: 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56: 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

26、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 Interval Prolongation) by Human Pharmaceuticals 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: I

27、mmunotoxicology 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 Pharmaceuticals抗癌药物的临床前评价S10: Photosafety Evaluation 光安全评价14. S10: Photosafety Evaluation

28、 of Pharmaceuticals药物的光安全评价三、ICH.临床部分(Eficacy)E1: Clinical Safety for Drugs used in Long -Term Treatment 长期治疗药物的临床 安全性15. 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

29、 - E2F: Pharmacovigilance 药物警戒16. E2A: Definitions and Standards for Expedited Reporting快速报告的定义和标准17. E2C(R2): Periodic Benefit-Risk Evaluation Report上市药品定期风险效益评估报告18. 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19. E2E: Pharmacovi

30、gilance Planning药物警戒计划20. E2F: Development Safety Update Report 安全性更新报告E3: Clinical Study Reports 临床研究报告21. 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22. 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

31、23. 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24. E6(R1): Good Clinical Practice: Consolidated Guideline药品临床研究规范(GCP) 一致性指导原则25. E6(R2): Integrated Addendum to ich E6(R1): Guideline for Good Clinical PracticeE6(R1)整合的附录：

32、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26. 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27. 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28.

33、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29. 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30. E11: Clinical Investigation of Medicinal Produc

34、ts 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31. 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32. E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proa

35、rrhythmicPotential 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33. 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

36、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34. 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35. E17: General principle

37、 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36. 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四、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37. M3: Guidance on Nonclinical Safety Studies for the