ICH 指导原则文件目录(中英文).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。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):StabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的稳定性试验4. Q1B:PhotostabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的光稳定性试验5. Q1C:StabilityTestingforNewDosageForms新剂型的稳定性试验6. Q1D:BracketingandMatrixingDesignsforStabilityTestingofDrugSubstancesand DrugProducts原料药和制剂稳定性试验的交叉和矩阵设计Q1E:EvaluationofStabilityData稳定性数据的评估7. Q1F:StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV在气候带III和IV，药物注册申请所提供的稳定性数据8. Q2:AnalyticalValidation分析验证9. Q2(R1):ValidationofAnalyticalProcedures:TextandMethodology分析程序的验证：正文及方法论10. Q3:Impurities杂质11. Q3A(R2):ImpuritiesinNewDrugSubstances新原料药中的杂质12. Q3B(R2):ImpuritiesinNewDrugProducts(RevisedGuideline)新制剂中的杂质13. Q3C(R3):Impurities:GuidelineforResidualSolvents杂质：残留溶剂指南Impurities:GuidelineforResidualSolvents(Maintenance)杂质：残留溶剂指南(保留)PDEforTetrahydrofuran(inQ3C(R3)四氢呋喃的日允许接触剂量PDEforN-Methylpyrrolidone(inQ3C(R3)N-甲基吡咯烷酮的日允许接触剂量14. Q4:Pharmacopoeias药典15. Q4A:PharmacopoeialHarmonisation药典的协调16. Q4B:EvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegions药典内容的评估及推荐为用于ICH地区17. Q4BAnnex1EvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegionsonResidueonIgnition/SulphatedAshGeneralChapter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. Q4BAnnex2EvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegionsonTestforExtractableVolumeofParenteralPreparationsGeneralChapter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. Q4BAnnex3EvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegionsonTestforParticulateContamination:Sub-VisibleParticlesGeneralChapter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:QualityofBiotechnologicalProducts生物技术制品质量21. Q5A(R1):ViralSafetyEvaluationofBiotechnologyProductsDerivedfromCellLinesofHumanorAnimalOrigin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:QualityofBiotechnologicalProducts:AnalysisoftheExpressionConstructinCellsUsedforProductionofr-DNADerivedProteinProducts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:QualityofBiotechnologicalProducts:StabilityTestingofBiotechnological/BiologicalProducts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:DerivationandCharacterizationofCellSubstratesUsedforProductionofBiotechnological/BiologicalProducts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:ComparabilityofBiotechnological/BiologicalProductsSubjecttoChangesinTheirManufacturingProcess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:TestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProducts:ChemicalSubstances(includingdecisiontrees)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:TestProceduresandAcceptanceCriteriafor29. Biotechnological/BiologicalProducts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:GoodManufacturingPractices（GMP）31. Q7A:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药物成份的GMP指南32. Q8:PharmaceuticalDevelopment药物研发33. AnnextoQ8Q8附录34. Q9:QualityRiskManagement质量风险管理35. Q10:PharmaceuticalQualitySystem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光毒性评价？ 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安全性更新报告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抗高血压新药的临床评价指导原则 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、药物遗传学、基因组数据和样本编码分类的定义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、结构和格式四、ICH.综合部分(Multidisciplinary)1. M1医学术语Med DRA2. M2 Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1) companion document to E2B(R3)关于E2B个体病例的安全性报告的电子传递指南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关于拟进行药物人体临床试验和上市许可申请的药物临床前研究指导原则与临床研究有关的临床前研究的时间安排4. M4Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use人用药物注册申请的通用技术文件编写说明？ (Edited with Numbering and Section Header Changes, September 2002). Including the Annex : the Granularity Document (Revised November 2003).CTD（commontechnicaldocument）（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