ICH-指导原则文件目录.docx

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/Q2.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。一、ICH. 质量部分（Quality） Q1: 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 Substances 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 Methodology 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 Solvents PDE for Triethylamine 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 Regions ICH地区使用的药典正文评估和建议 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 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 Recommendation 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 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 Use 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 and 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 Polyacrylamide 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 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 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 Biotechnological 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 Products 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 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 Manufacture 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）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 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 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: Duration 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. 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 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 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 Pharmaceuticals抗癌药物的临床前评价S10: Photosafety Evaluation 光安全评价14. S10: Photosafety Evaluation of Pharmaceuticals 药物的光安全评价三、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 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 - 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: 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 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-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): 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 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 Trials 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 Evaluation of QT QT临床评价18. E14: The Clinical Evaluation of QT/QTc Interval Prolongation and ProarrhythmicPotential 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, 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1. M3: Guidance on Nonclinical Safety Stud