ICH-系列指导原则

ICH：Quality质量Q1A(R2):StabilityTestingofNewDrugSubstancesandProducts(SecondRevision)新原料药和制剂的稳定性试验（第二版）Q1B:PhotostabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的光稳定性试验Q1C:StabilityTestingforNewDosageForms新制剂的稳定性试验Q1D:BracketingandMatrixingDesignsforStabilityTestingofDrugSubstancesandDrugProducts原料药和制剂稳定性试验的交叉和矩阵设计Q1E:EvaluationofStabilityData对稳定性数据的评估处理Q1F:StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV在气候带III和IV，药物注册申请所提供的稳定性数据Q2A:TextonValidationofAnalyticalProcedures分析程序的验证Q2B:ValidationofAnalyticalProcedures:Methodology分析程序的验证：方法学Q3A(R):ImpuritiesinNewDrugSubstances(RevisedGuideline)新原料药中的杂质（修订版）Q3B(R):ImpuritiesinNewDrugProducts(RevisedGuideline)新制剂中的杂质（修订版）Q3C:Impurities:GuidelineforResidualSolvents杂质：残留溶剂指南Q3C(M):Impurities:GuidelineforResidualSolvents(Maintenance)杂质：残留溶剂指南（修改内容）Q4:Pharmacopoeias药典Q4A:PharmacopoeialHarmonisation药典的协调Q4B:RegulatoryAcceptanceofPharmacopoeialInterchangeability药典互替在法规上的可接受性Q5A: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Q5D:DerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/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Q6:SpecificationsforNewDrugSubstancesandProducts新原料药和制剂的质量规格Q6A:Specifications:TestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProducts:ChemicalSubstances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Q6B:Specifications:TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalProducts质量规格：生物技术/生物产品的检验程序和可接收标准Q7:GoodManufacturingPracticesforPharmaceuticalIngredients活性药物成份的GMPQ7A:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药物成份的GMP指南Q8:PharmaceuticalDevelopment药物研发Q9:QualityRiskManagement质量风险管理ICH：Safety安全S1A:GuidelineontheNeedforCarcinogenicityStudiesofPharmaceuticals药物致癌性研究需要的指南S1B:TestingforCarcinogenicityofPharmaceuticals药物致癌性的检验S1C:DoseSelectionforCarcinogenicityStudiesofPharmaceuticals药物致癌性研究之剂量选择S1C(R):Addendum:AdditionofaLimitDoseandRelatedNotes附录：极限剂量和有关注释的的补充S2A:GuidanceonSpecificAspectsofRegulatoryGenotoxicityTestsforPharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B:Genotoxicity:AStandardBatteryforGenotoxicityTestingforPharmaceuticals基因毒性：药物基因毒性检验的标准S3A:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B:Pharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies药物代谢动力学：重复剂量的组织分布研究指南S4:SingleDoseToxicityTests单剂量毒性检验S4A:DurationofChronicToxicityTestinginAnimals(RodentandNon-RodentToxicityTesting)动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A:DetectionofToxicitytoReproductionforMedicinalProducts药物对生殖发育的毒性的检验S5B(M):MaintenanceoftheICHGuidelineonToxicitytoMaleFertility:AnAddendumtotheGuidelineonDetectionofToxicitytoReproductionforMedicinalProducts对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6:PreclinicalSafetyEvaluationofBiotechnology-DerivedPharmaceuticals生物技术生产的药物的临床前安全评价S7A:SafetyPharmacologyStudiesforHumanPharmaceuticals人用药的安全药理学研究S7B:TheNonclinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)ByHumanPharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8:ImmunotoxicologyStudiesforHumanPharmaceuticals人用药免疫毒理学研究M3(M):MaintenanceoftheICHGuidelineonNon-ClinicalSafetyStudiesfortheConductofHumanClinicalTrialsforPharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E1:TheExtentofPopulationExposuretoAssessClinicalSafetyforDrugsIntendedforLong-TermTreatmentofNon-Life-ThreateningConditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A:ClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting临床安全数据管理：速报制度的定义和标准E2B(R):RevisionoftheE2B(M)ICHGuidelineonClinicalSafetyDataManagementDataElementsforTransmissionofIndividualCaseSafetyReports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版E2B(M):MaintenanceoftheClinicalSafetyDataManagementincluding:DataElementsforTransmissionofIndividualCaseSafetyReports临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M):MaintenanceoftheClinicalSafetyDataManagementincludingQuestionsandAnswers临床安全数据管理的变动，包括问答E2C:ClinicalSafetyDataManagement:PeriodicSafetyUpdateReportsforMarketedDrugs临床安全数据管理：已上市药品的周期性安全数据更新报告AddendumtoE2C:PeriodicSafetyUpdateReportsforMarketedDrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D:Post-ApprovalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting批准后的安全数据管理：速报制度的定义和标准E2E:PharmacovigilancePlanning药物警戒计划E3:StructureandContentofClinicalStudyReports临床研究报告的结构和内容E4:Dose-ResponseInformationtoSupportDrugRegistration支持药品注册的剂量－效应资料E5:EthnicFactorsintheAcceptabilityofForeignClinicalData引入海外临床数据时要考虑的人种因素E6:GoodClinicalPractice:ConsolidatedGuidelineGCP：良好的临床规范：统一的指南E7:StudiesinSupportofSpecialPopulations:Geriatrics对特定族群的支持的研究：老人病学E8:GeneralConsiderationsforClini