最新ICH指导原则ppt课件

ICHGuidelines,1,ICHGuidelines,2,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,3,一、QualityGuidelines质量研究指导原则,HarmonisationachievementsintheQualityareaincludepivotalmilestonessuchastheconductofstabilitystudies,definingrelevantthresholdsforimpuritiestestingandamoreflexibleapproachtopharmaceuticalqualitybasedonGoodManufacturingPractice(GMP)riskmanagement.,4,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,5,Q2AnalyticalValidation分析验证,Q2(R1)ValidationofAnalyticalProcedures:TextandMethodology分析程序的验证：正文及方法论,6,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,7,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,8,Q4-Q4BPharmacopoeias药典,Q4BAnnex4BR1MicrobiologicalExaminationofNon-SterileProducts:TestsforSpecifiedMicro-OrganismsGeneralChapterQ4BAnnex4CR1MicrobiologicalExaminationofNon-SterileProducts:AcceptanceCriteriaforPharmaceuticalPreparationsandSubstancesforPharmaceuticalUseGeneralChapterQ4BAnnex5R1DisintegrationTestGeneralChapterQ4BAnnex6UniformityofDosageUnitsGeneralChapterQ4BAnnex7R2DissolutionTestGeneralChapterQ4BAnnex8R1SterilityTestGeneralChapter,9,Q4-Q4BPharmacopoeias药典,Q4BAnnex9R1TabletFriabilityGeneralChapterQ4BAnnex10R1PolyacrylamideGelElectrophoresisGeneralChapterQ4BAnnex11CapillaryElectrophoresisGeneralChapterQ4BAnnex12AnalyticalSievingGeneralChapterQ4BAnnex13BulkDensityandTappedDensityofPowdersGeneralChapterQ4BAnnex14BacterialEndotoxinsTestGeneralChapterQ4BFAQsFrequentlyAskedQuestions,10,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,11,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,12,Q7GoodManufacturingPractice(原料药GMP规范),Q7GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药物成份的GMP指南Q7QS2B:Genotoxicity:AStandardBatteryforGenotoxicityTestingforPharmaceuticals;,22,S3A-S3BToxicokineticsandPharmacokinetics毒代动力学和药代动力学,S3ANoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudiesS3AQ&AsQuestionsandAnswers:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposure-FocusonMicrosamplingS3BPharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies,23,S4ToxicityTesting毒性试验,S4DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting),24,S5ReproductiveToxicology生殖毒理学,S5(R2)DetectionofToxicitytoReproductionforMedicinalProducts&ToxicitytoMaleFertility,25,S6BiotechnologicalProducts生物技术制品,S6(R1)PreclinicalSafetyEvaluationofBiotechnology-DerivedPharmaceuticals,26,S7A-S7BPharmacologyStudies药理学研究,S7ASafetyPharmacologyStudiesforHumanPharmaceuticalsS7BTheNon-ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)byHumanPharmaceuticals,27,S8ImmunotoxicologyStudies免疫毒理学研究,S8ImmunotoxicityStudiesforHumanPharmaceuticals人类的药物免疫毒性研究,28,S9NonclinicalEvaluationforAnticancerPharmaceuticals抗癌药物非临床评价,S9NonclinicalEvaluationforAnticancerPharmaceuticalsS9Q&AsQuestionsandAnswers:NonclinicalEvaluationforAnticancerPharmaceuticals,29,S10PhotosafetyEvaluation光安全评价,S10PhotosafetyEvaluationofPharmaceuticals药物的光安全评价,30,S11NonclinicalSafetyTesting非临床安全性试验,S11NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicines,31,Cross-cuttingTopics,Cross-cuttingGuidelinesSomeICHProductsdonotfituniquelyintooneoftheQuality,SafetyorEfficacycategories.ThoseProductscanbefoundundertheMulidisciplinarySection.,32,三、EfficacyGuidelines有效性评价指导原则,TheworkcarriedoutbyICHundertheEfficacyheadingisconcernedwiththedesign,conduct,safetyandreportingofclinicaltrials.Italsocoversnoveltypesofmedicinesderivedfrombiotechnologicalprocessesandtheuseofpharmacogenetics/genomicstechniquestoproducebettertargetedmedicines,33,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,34,E2A-E2FPharmacovigilance药物警戒,E2AClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReportingE2B(R3)ClinicalSafetyDataManagement:DataElementsforTransmissionofIndividualCaseSafetyReportsE2B(R3)IWGImplementation:ElectronicTransmissionofIndividualCaseSafetyReportsE2C(R2)PeriodicBenefit-RiskEvaluationReport,35,E2C(R2)-E2F,E2C(R2)Q&AsQuestions&Answers:PeriodicBenefit-RiskEvaluationReportE2DPost-ApprovalSafetyDataManagement:DefinitionsandStandardsforExpeditedReportingE2EPharmacovigilancePlanningE2FDevelopmentSafetyUpdateReport,36,E3ClinicalStudyReports临床研究报告,E3StructureandContentofClinicalStudyReportsE3Q&AsR1Questions&Answers:StructureandContentofClinicalStudyReports,37,E4Dose-ResponseStudies剂量反应研究,E4Dose-ResponseInformationtoSupportDrugRegistration支持药品注册的剂量反应信息,38,E5EthnicFactors民族因素,E5(R1)EthnicFactorsintheAcceptabilityofForeignClinicalDataE5Q&As(R1)Questions&Answers:EthnicFactorsintheAcceptabilityofForeignClinicalData,39,E6GoodClinicalPractice临床试验规范,E6(R1)GoodClinicalPracticeE6(R2)Addendum:GoodClinicalPractice,40,E7ClinicalTrialsinGeriatricPopulation在老年人群中的临床试验,E7StudiesinSupportofSpecialPopulations:GeriatricsE7Q&AsQuestions&Answers:StudiesinSupportofSpecialPopulations:Geriatrics,41,E8GeneralConsiderationsforClinicalTrials临床试验的一般考虑,E8GeneralConsiderationsforClinicalTrials,42,E9StatisticalPrinciplesforClinicalTrials临床试验的统计学原理,E9StatisticalPrinciplesforClinicalTrialsE9(R1)Addendum:StatisticalPrinciplesforClinicalTrials,43,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,44,E11ClinicalTrialsinPediatricPopulation在儿科临床试验,E11ClinicalInvestigationofMedicinalProductsinthePediatricPopulationE11(R1)Addendum:ClinicalInvestigationofMedicinalProductsinthePediatricPopulation,45,E12ClinicalEvaluationbyTherapeuticCategory治疗类别临床评价,E12PrinciplesforClinicalEvaluationofNewAntihypertensiveDrugs,46,E14ClinicalEvaluation临床评价,E14TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugsE14Q&AsR2Questions&Answers:TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs,47,E15DefinitionsinPharmacogenetics/Pharmacogenomics药理学/药物基因组学的定义,E15DefinitionsforGenomicBiomarkers,Pharmacogenomics,Pharmacogenetics,GenomicDataandSampleCodingCategories,48,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,49,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,50,E18GenomicSamplingMethodologies基因组取样方法,E18GenomicSamplingMethodologiesforFutureUse,51,Cross-cuttingTopics,Cross-cuttingGuidelines,52,四、MultidisciplinaryGuidelines多学科指南,Thosearethecross-cuttingtopicswhichdonotfituniquelyintooneoftheQuality,SafetyandEfficacycategories.ItincludestheICHmedicalterminology(MedDRA),theCommonTechnicalDocument(CTD)andthedevelopmentofElectronicStandardsfortheTransferofRegulatoryInformation(ESTRI).,53,M1MedDRATerminology常用医学名词（MedDRA