ICH指导原则目录

QualityGuidelines（质量）编号阶段发布日期内容Q1Stability（稳定性）Q1A(R2)Step52003-2-6StabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的稳定性试验Q1BStep51996-11-6StabilityTesting:PhotostabilityTestingofNewDrugSubstancesandProducts稳定性试验：新原料药和制剂的光稳定性试验Q1CStep51996-11-6StabilityTestingforNewDosageForms稳定性试验：新剂型的要求Q1DStep52002-2-7BracketingandMatrixingDesignsforStabilityTestingofNewDrugSubstancesandProducts新原料药和制剂稳定性试验的括号法和矩阵法设计Q1EStep52003-2-6EvaluationofStabilityData稳定性数据的评价Q1F废止废止时间:2006-6-8StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV气候带III和IV注册申请的稳定性数据包Q2AnalyticalValidation（分析方法验证）Q2(R1)Step52005-11ValidationofAnalyticalProcedures:TextandMethodology分析方法验证：文本及方法学Q3Impurities（杂质）Q3A(R2)Step52006-10-25ImpuritiesinNewDrugSubstances新原料药中的杂质Q3B(R2)Step52006-6-2ImpuritiesinNewDrugProducts新药制剂中的杂质Q3C(R6)Step52016-10-20Impurities:GuidelineforResidualSolvents杂质：残留溶剂指南Q3DStep52014-12-16GuidelineforElementalImpurities元素杂质指南Q4Pharmacopoeias（药典）Q4Pharmacopoeias药典Q4APharmacopoeialHarmonisation药典的同一化Q4BStep52007-11-1EvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegionsICH各地区使用的药典正文评估和建议Q4BAnnex1(R1)Step52010-9-27ResidueonIgnition/SulphatedAshGeneralChapter关于ICH区域内药典附录的评价及建议-炽灼残渣（硫酸灰分）检查法Q4BAnnex2(R1)Step52010-9-27TestforExtractableVolumeofParenteralPreparationsGeneralChapter关于ICH区域内药典附录的评价及建议-注射剂装量检查法Q4BAnnex3(R1)Step52010-9-27TestforParticulateContamination:Sub-VisibleParticlesGeneralChapter关于ICH区域内药典附录的评价及建议-不溶性微粒检查法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Q5CStep51995-11-30QualityofBiotechnologicalProducts:StabilityTestingofBiotechnological/BiologicalProducts生物技术产品的质量：生物制品/生物技术产品的稳定性试验Q5DStep51997-7-16DerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/BiologicalProducts用于生物技术产品及生物制品生产的细胞基质的来源和鉴定Q5EStep52004-11-18ComparabilityofBiotechnological/BiologicalProductsSubjecttoChangesintheirManufacturingProcess生物技术产品/生物制品在工艺变更时的可比性Q6Specifications（质量标准）Q6AStep51999-10-6Specifications:TestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProducts:ChemicalSubstances质量标准新原料药和制剂的检测以及可接受标准：化学物质Q6BStep51999-3-10Specifications:TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalProducts质量标准：生物技术产品以及生物制品的检测方法和可接受标准Q7GoodManufacturingPractice（生产质量管理规范）Q7Step52000-11-10GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients原料药生产的GMP指南Q7Q&AsStep52015-6-10QuestionsandAnswers:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients原料药生产的GMP指南的问与答Q8PharmaceuticalDevelopment（药品研发）Q8(R2)Step52009-8PharmaceuticalDevelopment药品研发Q9QualityRiskManagement（质量风险管理）Q9Step52005-11-9QualityRiskManagement质量风险管理Q10PharmaceuticalQualitySystem（药物质量体系）Q10Step52008-6-4PharmaceuticalQualitySystem药品质量体系Q8/9/10Q&As(R4)Step5Q8/Q9/Q10QuestionsandAnswersQ8，Q9，Q10的问与答Q11DevelopmentandManufactureofDrugSubstances（原料药的研发和生产）Q11Step52012-5-1DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechnological/BiologicalEntities)药物的研发和生产（化学实体和生物技术产品/生物制品实体）Q11Q&AsStep42017-8-23Questions&Answers:SelectionandJustificationofStartingMaterialsfortheManufactureofDrugSubstancesQ11的问与答Q12LifecycleManagement（生命周期管理）Q12Step2TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagement药品生命周期的技术和监管考虑SafetyGuidelines（安全性）编号阶段发布日期内容S1CarcinogenicityStudies（致癌性研究）S1AStep51995-11-29NeedforCarcinogenicityStudiesofPharmaceuticals药物致癌试验的必要性S1BStep51997-07-16TestingforCarcinogenicityofPharmaceuticals药物致癌试验S1C(R2)Step52008-03-11DoseSelectionforCarcinogenicityStudiesofPharmaceuticals药物致癌试验的剂量选择S2GenotoxicityStudies（遗传毒性研究）S2(R1)Step52011-11-09GuidanceonGenotoxicityTestingandDataInterpretationforPharmaceuticalsIntendedforHumanUse人用药物的遗传毒性试验和数据分析指导原则S3ToxicokineticsandPharmacokinetics（毒代动力学和药代动力学）S3AStep51994-10-27NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudies毒代动力学指导原则：毒性研究中全身暴露的评价S3AQ&AsStep52017-11-16QuestionsandAnswers:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposure-FocusonMicrosamplingS3A问与答S3BStep51994-10-27Pharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies药代动力学：重复给药的组织分布研究指导原则S4ToxicityTesting（毒性试验）S4Step51998-09-02DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting)动物慢性毒性试验的周期（啮齿类和非啮齿类）S5ReproductiveToxicology（生殖毒性）S5(R2)Step52005-11DetectionofToxicitytoReproductionforMedicinalProducts&ToxicitytoMaleFertility药物生殖毒性和雄性生育力毒性的检测S5(R3)Step3RevisionofS5GuidelineonDetectionofToxicitytoReproductionforHumanPharmaceuticals关于S5中人用药物生殖毒性检测的修订S6BiotechnologicalProducts（生物技术药品）S6(R1)Step52011-6PreclinicalSafetyEvaluationofBiotechnology-DerivedPharmaceuticals生物技术药品的临床前安全性试验S7PharmacologyStudies（药理学研究）S7AStep52000-11-8SafetyPharmacologyStudiesforHumanPharmaceuticals人用药物的安全性药理学研究S7BStep52005-5-12TheNon-ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)byHumanPharmaceuticals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S8ImmunotoxicologyStudies（免疫毒性研究）S8Step52005-9-15ImmunotoxicityStudiesforHumanPharmaceuticals人用药品的免疫毒性研究S9NonclinicalEvaluationforAnticancerPharmaceuticals（抗癌药物的非临床研究）S9Step52009-10-29NonclinicalEvaluationforAnticancerPharmaceuticals抗癌药物的非临床评价S9Q&AsStep3QuestionsandAnswers:NonclinicalEvaluationforAnticancerPharmaceuticals抗癌药物非临床评价的问与答S10PhotosafetyEvaluation（光安全性研究）S10Step52013-11-13PhotosafetyEvaluationofPharmaceuticals药物的光安全性评价S11NonclinicalSafetyTesting（非临床安全性试验）S11Step1NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicines支持儿科药物研发的非临床研究EfficacyGuidelines（有效性）编号阶段发布日期内容E1ClinicalSafetyforDrugsusedinLong-TermTreatment（长期用药的临床安全性）E1Step51994-10-27TheExtentofPopulationExposuretoAssessClinicalSafetyforDrugsIntendedforLong-TermTreatmentofNon-LifeThreateningConditions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E2Pharmacovigilance（药物警戒）E2AStep51994-10-27ClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting临床安全性数据管理：快速报告的定义和标准E2B(R3)Step52015-4ClinicalSafetyDataManagement:DataElementsforTransmissionofIndividualCaseSafetyReports临床安全性数据管理：个体病例安全性报告传递的数据要素E2B(R3)IWGStep52016-6-16Implementation:ElectronicTransmissionofIndividualCaseSafetyReports关于E2B(R3)实施的问与答E2C(R2)Step52012-12-17PeriodicBenefit-RiskEvaluationReport上市药品定期风险效益评估报告E2C(R2)Q&AsStep52014-3-31Questions&Answers:PeriodicBenefit-RiskEvaluationReport上市药品定期风险效益评估报告的问与答E2DStep52003-11-12Post-ApprovalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting批准后的安全数据管理：快速报告的定义和标准E2EStep52004-11-18PharmacovigilancePlanning药物警戒计划E2FStep52010-8-17DevelopmentSafetyUpdateReport研发安全性更新报告E3ClinicalStudyReports（临床研究报告）E3Step51995-11-30StructureandContentofClinicalStudyReports临床研究报告的结构与内容E3Q&As(R1)Step52012-7-6Questions&Answers:StructureandContentofClinicalStudyReports临床研究报告的结构与内容问与答E4Dose-ResponseStudies（量-效关系研究）E4Step51994-3-10Dose-ResponseInformationtoSupportDrugRegistration新药注册所需的量-效关系资料E5EthnicFactors（种族因素）E5(R1)Step51998-2-5EthnicFactorsintheAcceptabilityofForeignClinicalData引入海外临床数据时要考虑的种族因素E5Q&As(R1)Step52006-6-2Questions&Answers:EthnicFactorsintheAcceptabilityofForeignClinicalData引入海外临床数据时要考虑的种族因素的问与答E6GoodClinicalPractice（药物临床研究质量管理规范）E6(R2)Step52016-11-9药物临床研究规范GoodClinicalPractice（GCP）E7ClinicalTrialsinGeriatricPopulation（老年人群的临床试验）E7Step51993-6-24StudiesinSupportofSpecialPopulations:Geriatrics老年人群的临床研究E7Q&AsStep52010-7-6Questions&Answers:StudiesinSupportofSpecialPopulations:Geriatrics老年人群的临床研究的问与答E8GeneralConsiderationsforClinicalTrials（临床试验的一般考虑）E8Step51997-7-17GeneralConsiderationsforClinicalTrials临床试验的一般考虑E8(R1)Step1RevisiononGeneralConsiderationsforClinicalTrials临床试验一般考虑的修订E9StatisticalPrinciplesforClinicalTrials（临床试验的统计原则）E9Step51998-2-5StatisticalPrinciplesforClinicalTrials临床试验统计原则E9(R1)Step3Addendum:StatisticalPrinciplesforClinicalTrialsE9附录E10ChoiceofControlGroupinClinicalTrials（临床试验中对照组的选取）E10Step52000-7-20ChoiceofControlGroupandRelatedIssuesinClinicalTrials临床试验的对照组选择及相关问题E11ClinicalTrialsinPediatricPopulation（儿童用药品的临床试验）E11Step52000-7-20ClinicalInvestigationofMedicinalProductsinthePediatricPopulation儿童用药品的临床调查E11(R1)Step52017-7-20Addendum:ClinicalInvestigationofMedicinalProductsinthePediatricPopulationE11附录E11AStep1PaediatricExtrapolation儿科外推E12ClinicalEvaluationbyTherapeuticCategory（新抗高血压药的临床评价）E12Step52000-3-2PrinciplesforClinicalEvaluationofNewAntihypertensiveDrugs新抗高血压药的临床评价原则E14ClinicalEvaluationofQT（QT临床评价）E14Step52005-5-12TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs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E14Q&As(R3)Step52015-12-10Questions&Answers:TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugsE14的问与答E14/S7BStep1DiscussionGrouponClinicalandnon-ClinicalEvaluationofQT/QTcIntervalProlongationQT/QTc间期延长的临床和非临床评价讨论组E15DefinitionsinPharmacogenetics/Pharmacogenomics（药物遗传学/药物基因组学的定义）E15Step52007-11-1DefinitionsforGenomicBiomarkers,Pharmacogenomics,Pharmacogenetics,GenomicDataandSampleCodingCategories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E16QualificationofGenomicBiomarkers（基因组生物标记物的条件）E16Step52010-8-20BiomarkersRelatedtoDrugorBiotechnologyProductDevelopment:Context,StructureandFormatofQualificationSubmissions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E17Multi-RegionalClinicalTrials（国际多中心临床试验）E17Step52017-11-16Generalprincipleonplanning/designingMulti-RegionalClinicalTrials国际多中心临床试验计划与设计原则E18GenomicSampling（基因组采样）E18Step52017-8-3GenomicSamplingandManagementofGenomicData基因组样品采集和基因组数据管理指南E19SafetyDataCollection（安全性数据收集）E19Step1OptimisationofSafetyDataCollection安全性数据收集的优化MultidisciplinaryGuidelines（多学科综合）编号阶段发布日期内容M1MedDRATerminology（监管活动医学术语）M1Version20.12017-9MedicalDictionaryforRegulatoryActivities(MedDRA)监管活动医学术语M2ElectronicStandards（电子标准）M2ElectronicStandardsfortheTransferofRegulatoryInformation(ESTRI)监管信息传输电子标准M3NonclinicalSafetyStudies（非临床安全性研究）M3(R2)Step52009-6-11GuidanceonNonclinicalSafetyStudiesfortheConductofHumanClinicalTrialsandMarketingAuthorizationforPharmaceuticals药物进行人体临床试验和上市许可申请的非临床安全性研究指导原则M3(R2)Q&As(R2)Step52012-3-5Questions&Answers:GuidanceonNon-ClinicalSafetyStudiesfortheConductofHumanClinicalTrialsandMarketingAuthorizationforPharmaceuticalsM3的问与答M4CommonTechnicalDocument（通用技术文件）M4TheCommonTechnicalDocument(CTD)通用技术文件M4(R4)Step52016-6-15OrganisationoftheCommonTechnicalDocumentForTheRegistrationofPharmaceuticalsforhumanuse人用药物注册申请的通用技术文件组织结构M4Q(R1)Step52002-9-12TheCommonTechnicalDocumentfortheRegistationofPharmaceuticals