最新ICH指导原则完整可编辑版本精选ppt课件.ppt

ICHGuidelines ICHGuidelines 说明 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 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 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 MedDRA 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 QualityGuidelines质量研究指导原则 HarmonisationachievementsintheQualityareaincludepivotalmilestonessuchastheconductofstabilitystudies definingrelevantthresholdsforimpuritiestestingandamoreflexibleapproachtopharmaceuticalqualitybasedonGoodManufacturingPractice GMP riskmanagement Q1A Q1FStability稳定性 Q1A R2 StabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的稳定性试验Q1BStabilityTesting PhotostabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的光稳定性试验Q1CStabilityTestingforNewDosageForms新剂型的稳定性试验Q1DBracketingandMatrixingDesignsforStabilityTestingofNewDrugSubstancesandProducts原料药和制剂稳定性试验的交叉和矩阵设计Q1EEvaluationofStabilityData稳定性数据的评估Q1FStabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV在气候带III和IV 药物注册申请所提供的稳定性数据 Q2AnalyticalValidation分析验证 Q2 R1 ValidationofAnalyticalProcedures TextandMethodology分析程序的验证 正文及方法论 Q3A Q3DImpurities杂质 Q3A R2 ImpuritiesinNewDrugSubstances新原料药中的杂质Q3B R2 ImpuritiesinNewDrugProducts新制剂中的杂质Q3C R5 Impurities GuidelineforResidualSolvents杂质 残留溶剂指南Q3DGuidelineforElementalImpurities NEWQ3DImplementationofGuidelineforElementalImpurities Q4 Q4BPharmacopoeias药典 Q4Pharmacopoeias药典Q4APharmacopoeialHarmonisation药典的协调Q4BEvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegions药典内容的评估及推荐为用于ICH地区Q4BAnnex1R1ResidueonIgnition SulphatedAshGeneralChapter附录1关于灼烧残渣 灰分常规篇Q4BAnnex2R1TestforExtractableVolumeofParenteralPreparationsGeneralChapter关于注射剂可提取容量测试常规篇Q4BAnnex3R1TestforParticulateContamination Sub VisibleParticlesGeneralChapter附录3关于颗粒污染物测试 不溶性微粒常规篇Q4BAnnex4AR1MicrobiologicalExaminationofNon SterileProducts MicrobialEnumerationTestsGeneralChapter Q4 Q4BPharmacopoeias药典 Q4BAnnex4BR1MicrobiologicalExaminationofNon SterileProducts TestsforSpecifiedMicro OrganismsGeneralChapterQ4BAnnex4CR1MicrobiologicalExaminationofNon SterileProducts AcceptanceCriteriaforPharmaceuticalPreparationsandSubstancesforPharmaceuticalUseGeneralChapterQ4BAnnex5R1DisintegrationTestGeneralChapterQ4BAnnex6UniformityofDosageUnitsGeneralChapterQ4BAnnex7R2DissolutionTestGeneralChapterQ4BAnnex8R1SterilityTestGeneralChapter Q4 Q4BPharmacopoeias药典 Q4BAnnex9R1TabletFriabilityGeneralChapterQ4BAnnex10R1PolyacrylamideGelElectrophoresisGeneralChapterQ4BAnnex11CapillaryElectrophoresisGeneralChapterQ4BAnnex12AnalyticalSievingGeneralChapterQ4BAnnex13BulkDensityandTappedDensityofPowdersGeneralChapterQ4BAnnex14BacterialEndotoxinsTestGeneralChapterQ4BFAQsFrequentlyAskedQuestions Q5A Q5EQualityofBiotechnologicalProducts生物技术产品的质量 Q5A R1 ViralSafetyEvaluationofBiotechnologyProductsDerivedfromCellLinesofHumanorAnimalOrigin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Q5BAnalysisoftheExpressionConstructinCellsUsedforProductionofr 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Q5CStabilityTestingofBiotechnological BiologicalProducts生物技术产品的质量 生物技术 生物产品的稳定性试验Q5DDerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological 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Q5EComparabilityofBiotechnological 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 Q6A Q6BSpecifications规格 Q6ASpecifications 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 包括决定过程 Q6BSpecifications 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 Q7GoodManufacturingPractice 原料药GMP规范 Q7GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药物成份的GMP指南Q7Q AsQuestionsandAnswers GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients Q8PharmaceuticalDevelopment药物开发 Q8 R2 PharmaceuticalDevelopment药物开发Q8 9 10Q AsR4Q8 Q9 Q10 Implementation Q9QualityRiskManagement质量风险管理 Q9QualityRiskManagementQ8 9 10Q AsR4Q8 Q9 Q10 Implementation Q10PharmaceuticalQualitySystem药物质量体系 Q10PharmaceuticalQualitySystem药物质量体系Q8 9 10Q AsR4Q8 Q9 Q10 Implementation实施 Q11DevelopmentandManufactureofDrugSubstances原料药研发与生产 Q11DevelopmentandManufactureofDrugSubstances ChemicalEntitiesandBiotechnological BiologicalEntities Q11Q AsQuestions Answers SelectionandJustificationofStartingMaterialsfortheManufactureofDrugSubstances Q12LifecycleManagement生命周期管理 Q12TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagement Cross cuttingTopics Cross cuttingGuidelines 二 SafetyGuidelines安全性评价指导原则 ICHhasproducedacomprehensivesetofsafetyGuidelinestouncoverpotentialriskslikecarcinogenicity genotoxicityandreprotoxicity Arecentbreakthroughhasbeenanon clinicaltestingstrategyforassessingtheQTintervalprolongationliability thesinglemostimportantcauseofdrugwithdrawalsinrecentyears S1A S1CCarcinogenicityStudies致癌性研究 S1RodentCarcinogenicityStudiesforHumanPharmaceuticalsS1ANeedforCarcinogenicityStudiesofPharmaceuticalsS1BTestingforCarcinogenicityofPharmaceuticalsS1C R2 DoseSelectionforCarcinogenicityStudiesofPharmaceuticals S2GenotoxicityStudies遗传毒性研究 S2 R1 GuidanceonGenotoxicityTestingandDataInterpretationforPharmaceuticalsIntendedforHumanUseS2A GuidanceonSpecificAspectsofRegulatoryGenotoxicityTestsforPharmaceuticals S2B Genotoxicity AStandardBatteryforGenotoxicityTestingforPharmaceuticals S3A S3BToxicokineticsandPharmacokinetics毒代动力学和药代动力学 S3ANoteforGuidanceonToxicokinetics TheAssessmentofSystemicExposureinToxicityStudiesS3AQ AsQuestionsandAnswers NoteforGuidanceonToxicokinetics TheAssessmentofSystemicExposure FocusonMicrosamplingS3BPharmacokinetics GuidanceforRepeatedDoseTissueDistributionStudies S4ToxicityTesting毒性试验 S4DurationofChronicToxicityTestinginAnimals RodentandNonRodentToxicityTesting S5ReproductiveToxicology生殖毒理学 S5 R2 DetectionofToxicitytoReproductionforMedicinalProducts ToxicitytoMaleFertility S6BiotechnologicalProducts生物技术制品 S6 R1 PreclinicalSafetyEvaluationofBiotechnology DerivedPharmaceuticals S7A S7BPharmacologyStudies药理学研究 S7ASafetyPharmacologyStudiesforHumanPharmaceuticalsS7BTheNon ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization QTIntervalProlongation byHumanPharmaceuticals S8ImmunotoxicologyStudies免疫毒理学研究 S8ImmunotoxicityStudiesforHumanPharmaceuticals人类的药物免疫毒性研究 S9NonclinicalEvaluationforAnticancerPharmaceuticals抗癌药物非临床评价 S9NonclinicalEvaluationforAnticancerPharmaceuticalsS9Q AsQuestionsandAnswers NonclinicalEvaluationforAnticancerPharmaceuticals S10PhotosafetyEvaluation光安全评价 S10PhotosafetyEvaluationofPharmaceuticals药物的光安全评价 S11NonclinicalSafetyTesting非临床安全性试验 S11NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicines Cross cuttingTopics Cross cuttingGuidelinesSomeICHProductsdonotfituniquelyintooneoftheQuality SafetyorEfficacycategories ThoseProductscanbefoundundertheMulidisciplinarySection 三 EfficacyGuidelines有效性评价指导原则 TheworkcarriedoutbyICHundertheEfficacyheadingisconcernedwiththedesign conduct safetyandreportingofclinicaltrials Italsocoversnoveltypesofmedicinesderivedfrombiotechnologicalprocessesandtheuseofpharmacogenetics genomicstechniquestoproducebettertargetedmedicines E1ClinicalSafetyforDrugsusedinLong TermTreatment用于长期治疗药物的临床安全性 E1TheExtentofPopulationExposuretoAssessClinicalSafetyforDrugsIntendedforLong TermTreatmentofNon LifeThreateningConditions要评估用于非危及生命的疾病的长期治疗药物的临床安全性人群暴露程度 E2A E2FPharmacovigilance药物警戒 E2AClinicalSafetyDataManagement DefinitionsandStandardsforExpeditedReportingE2B R3 ClinicalSafetyDataManagement DataElementsforTransmissionofIndividualCaseSafetyReportsE2B R3 IWGImplementation ElectronicTransmissionofIndividualCaseSafetyReportsE2C R2 PeriodicBenefit RiskEvaluationReport E2C R2 E2F E2C R2 Q AsQuestions Answers PeriodicBenefit RiskEvaluationReportE2DPost ApprovalSafetyDataManagement DefinitionsandStandardsforExpeditedReportingE2EPharmacovigilancePlanningE2FDevelopmentSafetyUpdateReport E3ClinicalStudyReports临床研究报告 E3StructureandContentofClinicalStudyReportsE3Q AsR1Questions Answers StructureandContentofClinicalStudyReports E4Dose ResponseStudies剂量反应研究 E4Dose ResponseInformationtoSupportDrugRegistration支持药品注册的剂量反应信息 E5EthnicFactors民族因素 E5 R1 EthnicFactorsintheAcceptabilityofForeignClinicalDataE5Q As R1 Questions Answers EthnicFactorsintheAcceptabilityofForeignClinicalData E6GoodClinicalPractice临床试验规范 E6 R1 GoodClinicalPracticeE6 R2 Addendum GoodClinicalPractice E7ClinicalTrialsinGeriatricPopulation在老年人群中的临床试验 E7StudiesinSupportofSpecialPopulations GeriatricsE7Q AsQuestions Answers StudiesinSupportofSpecialPopulations Geriatrics E8GeneralConsiderationsforClinicalTrials临床试验的一般考虑 E8GeneralConsiderationsforClinicalTrials E9StatisticalPrinciplesforClinicalTrials临床试验的统计学原理 E9StatisticalPrinciplesforClinicalTrialsE9 R1 Addendum StatisticalPrinciplesforClinicalTrials E10ChoiceofControlGroupinClinicalTrials临床试验中对照组的选择 E10ChoiceofControlGroupandRelatedIssuesinClinicalTrials在临床试验中的对照组和相关问题的选择 E11ClinicalTrialsinPediatricPopulation在儿科临床试验 E11ClinicalInvestigationofMedicinalProductsinthePediatricPopulationE11 R1 Addendum ClinicalInvestigationofMedicinalProductsinthePediatricPopulation E12ClinicalEvaluationbyTherapeuticCategory治疗类别临床评价 E12PrinciplesforClinicalEvaluationofNewAntihypertensiveDrugs E14ClinicalEvaluation临床评价 E14TheClinicalEvaluationofQT QTcIntervalProlongationandProarrhythmicPotentialforNon AntiarrhythmicDrugsE14Q AsR2Questions Answers TheClinicalEvaluationofQT QTcIntervalProlongationandProarrhythmicPotentialforNon AntiarrhythmicDrugs E15DefinitionsinPharmacogenetics Pharmacogenomics药理学 药物基因组学的定义 E15DefinitionsforGenomicBiomarkers Pharmacogenomics Pharmacogenetics GenomicDataandSampleCodingCategories E16QualificationofGenomicBiomarkers基因组生物标志物的资格 E16BiomarkersRelatedtoDrugorBiotechnologyProductDevelopment Context StructureandFormatofQualificationSubmissions药物或生物技术产品开发相关的生物标志物 上下文 结构和资格文件格式 E17Multi RegionalClinicalTrials多区域临床试验 E17Generalprincipleonplanning designingMulti RegionalClinicalTrials在规划 设计多区域临床试验的一般原则 E18GenomicSamplingMethodologies基因组取样方法 E18GenomicSamplingMethodologiesforFutureUse Cross cuttingTopics Cross cuttingGuidelines 四 MultidisciplinaryGuidelines多学科指南 Thosearethecross cuttingtopicswhichdonotfituniquelyintooneoftheQuality SafetyandEfficacycategories ItincludestheICHmedicalterminology MedDRA theCommonTechni