最ICH指导建议建议原则专家讲座

ICHGuidelines第1页说明ICH论题主要分为四类，所以ICH依据论题类别不一样而进行对应编码分类：“Q”类论题：Q代表QUALITY，指那些与化工和医药，质量确保方面相关论题。“S”类论题：S代表SAFETY，指那些与试验室和动物试验，临床前研究方面相关论题。3.“E”类论题：E代表EFFICACY，指那些与人类临床研究相关课题。4.“M”类论题：M代表MULTIDISCIPLINARY,指那些不可单独划入以上三个分类交叉包括论题。同时M又细分为5个小类

M1:惯用医学名词（MedDRA）

M2:药政信息传递之电子标准

M3:与临床试验相关临床前研究时间安排

M4:常规技术文件(CTD)

M5:药品词典数据要素和标准第2页一、QualityGuidelines

质量研究指导标准

HarmonisationachievementsintheQualityareaincludepivotalmilestonessuchastheconductofstabilitystudies,definingrelevantthresholdsforimpuritiestestingandamoreflexibleapproachtopharmaceuticalqualitybasedonGoodManufacturingPractice(GMP)riskmanagement.

第3页Q1A-Q1FStability稳定性

Q1A(R2)StabilityTestingofNewDrugSubstancesandProducts

新原料药和制剂稳定性试验Q1BStabilityTesting:PhotostabilityTestingofNewDrugSubstancesandProducts

新原料药和制剂光稳定性试验Q1CStabilityTestingforNewDosageForms新剂型稳定性试验Q1DBracketingandMatrixingDesignsforStabilityTestingofNewDrugSubstancesandProducts

原料药和制剂稳定性试验交叉和矩阵设计Q1EEvaluationofStabilityData稳定性数据评定Q1FStabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV

在气候带III和IV，药品注册申请所提供稳定性数据

第4页Q2AnalyticalValidation分析验证Q2(R1)ValidationofAnalyticalProcedures:TextandMethodology分析程序验证：正文及方法论

第5页Q3A-Q3DImpurities杂质Q3A(R2)ImpuritiesinNewDrugSubstances新原料药中杂质Q3B(R2)ImpuritiesinNewDrugProducts新制剂中杂质Q3C(R5)Impurities:GuidelineforResidualSolvents杂质：残留溶剂指南Q3DGuidelineforElementalImpurities-NEWQ3DImplementationofGuidelineforElementalImpurities第6页Q4-Q4BPharmacopoeias药典

Q4Pharmacopoeias药典

Q4APharmacopoeialHarmonisation药典协调Q4BEvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegions药典内容评定及推荐为用于ICH地域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

第7页Q4-Q4BPharmacopoeias药典

Q4BAnnex4BR1MicrobiologicalExaminationofNon-SterileProducts:TestsforSpecifiedMicro-OrganismsGeneralChapterQ4BAnnex4CR1MicrobiologicalExaminationofNon-SterileProducts:AcceptanceCriteriaforPharmaceuticalPreparationsandSubstancesforPharmaceuticalUseGeneralChapterQ4BAnnex5R1DisintegrationTestGeneralChapterQ4BAnnex6UniformityofDosageUnitsGeneralChapterQ4BAnnex7R2DissolutionTestGeneralChapterQ4BAnnex8R1SterilityTestGeneralChapter

第8页Q4-Q4BPharmacopoeias药典

Q4BAnnex9R1TabletFriabilityGeneralChapterQ4BAnnex10R1PolyacrylamideGelElectrophoresisGeneralChapterQ4BAnnex11CapillaryElectrophoresisGeneralChapterQ4BAnnex12AnalyticalSievingGeneralChapterQ4BAnnex13BulkDensityandTappedDensityofPowdersGeneralChapterQ4BAnnex14BacterialEndotoxinsTestGeneralChapterQ4BFAQsFrequentlyAskedQuestions第9页Q5A-Q5EQualityofBiotechnologicalProducts

生物技术产品质量Q5A(R1)ViralSafetyEvaluationofBiotechnologyProductsDerivedfromCellLinesofHumanorAnimalOrigin

源于人或者动物细胞系生物技术产品病毒安全性评定Q5BAnalysisoftheExpressionConstructinCellsUsedforProductionofr-DNADerivedProteinProducts

生物技术产品质量：源于重组DNA蛋白质产品生产中所用细胞中表示构建分析Q5CStabilityTestingofBiotechnological/BiologicalProducts

生物技术产品质量：生物技术/生物产品稳定性试验Q5DDerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/BiologicalProducts

用于生产生物技术/生物产品细胞底物起源和特征描述Q5EComparabilityofBiotechnological/BiologicalProductsSubjecttoChangesintheirManufacturingProcess

基于不一样生产工艺生物技术产品/生物产品可比较性

第10页Q6A-Q6BSpecifications规格Q6ASpecifications:TestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProducts:ChemicalSubstances质量规格：新原料药和新制剂检验程序和可接收标准：化学物质(包含决定过程)Q6BSpecifications:TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalProducts

质量规格：生物技术/生物产品检验程序和可接收标准

第11页Q7GoodManufacturingPractice

(原料药GMP规范)Q7GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药品成份GMP指南

Q7Q&AsQuestionsandAnswers:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients第12页Q8PharmaceuticalDevelopment药品开发Q8(R2)PharmaceuticalDevelopment

药品开发Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation第13页Q9QualityRiskManagement

质量风险管理Q9QualityRiskManagement

Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation第14页Q10PharmaceuticalQualitySystem药品质量体系Q10PharmaceuticalQualitySystem

药品质量体系

Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation实施第15页Q11DevelopmentandManufactureofDrugSubstances原料药研发与生产Q11DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechnological/BiologicalEntities)Q11Q&AsQuestions&Answers:SelectionandJustificationofStartingMaterialsfortheManufactureofDrugSubstances

第16页Q12LifecycleManagement

生命周期管理

Q12TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagement第17页Cross-cuttingTopicsCross-cuttingGuidelines第18页二、SafetyGuidelines

安全性评价指导标准

ICHhasproducedacomprehensivesetofsafetyGuidelinestouncoverpotentialriskslikecarcinogenicity,genotoxicityandreprotoxicity.Arecentbreakthroughhasbeenanon-clinicaltestingstrategyforassessingtheQTintervalprolongationliability:thesinglemostimportantcauseofdrugwithdrawalsinrecentyears.第19页S1A-S1CCarcinogenicityStudies致癌性研究S1RodentCarcinogenicityStudiesforHumanPharmaceuticalsS1ANeedforCarcinogenicityStudiesofPharmaceuticalsS1BTestingforCarcinogenicityofPharmaceuticalsS1C(R2)DoseSelectionforCarcinogenicityStudiesofPharmaceuticals

第20页S2GenotoxicityStudies

遗传毒性研究S2(R1)GuidanceonGenotoxicityTestingandDataInterpretationforPharmaceuticalsIntendedforHumanUseS2A:GuidanceonSpecificAspectsofRegulatoryGenotoxicityTestsforPharmaceuticals;S2B:Genotoxicity:AStandardBatteryforGenotoxicityTestingforPharmaceuticals;

第21页S3A-S3BToxicokineticsandPharmacokinetics毒代动力学和药代动力学

S3ANoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudiesS3AQ&AsQuestionsandAnswers:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposure-FocusonMicrosamplingS3BPharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies第22页S4ToxicityTesting毒性试验S4DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting)

第23页S5ReproductiveToxicology

生殖毒理学S5(R2)DetectionofToxicitytoReproductionforMedicinalProducts&ToxicitytoMaleFertility第24页S6BiotechnologicalProducts

生物技术制品S6(R1)PreclinicalSafetyEvaluationofBiotechnology-DerivedPharmaceuticals

第25页S7A-S7B

PharmacologyStudies药理学研究S7ASafetyPharmacologyStudiesforHumanPharmaceuticalsS7BTheNon-ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)byHumanPharmaceuticals第26页S8ImmunotoxicologyStudies

免疫毒理学研究S8ImmunotoxicityStudiesforHumanPharmaceuticals人类药品免疫毒性研究第27页S9NonclinicalEvaluationforAnticancerPharmaceuticals抗癌药品非临床评价

S9NonclinicalEvaluationforAnticancerPharmaceuticalsS9Q&AsQuestionsandAnswers:NonclinicalEvaluationforAnticancerPharmaceuticals第28页S10PhotosafetyEvaluation

光安全评价S10PhotosafetyEvaluationofPharmaceuticals药品光安全评价第29页S11NonclinicalSafetyTesting

非临床安全性试验S11NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicines第30页Cross-cuttingTopicsCross-cuttingGuidelinesSomeICHProductsdonotfituniquelyintooneoftheQuality,SafetyorEfficacycategories.ThoseProductscanbefoundunderthe

Mulidisciplinary

Section.第31页三、EfficacyGuidelines

有效性评价指导标准

TheworkcarriedoutbyICHundertheEfficacyheadingisconcernedwiththedesign,conduct,safetyandreportingofclinicaltrials.Italsocoversnoveltypesofmedicinesderivedfrombiotechnologicalprocessesandtheuseofpharmacogenetics/genomicstechniquestoproducebettertargetedmedicines第32页E1ClinicalSafetyforDrugsusedinLong-TermTreatment用于长久治疗药品临床安全性

E1TheExtentofPopulationExposuretoAssessClinicalSafetyforDrugsIntendedforLong-TermTreatmentofNon-LifeThreateningConditions要评定用于非危及生命疾病长久治疗药品临床安全性人群暴露程度第33页E2A-E2FPharmacovigilance

药品警戒E2AClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReportingE2B(R3)ClinicalSafetyDataManagement:DataElementsforTransmissionofIndividualCaseSafetyReportsE2B(R3)IWGImplementation:ElectronicTransmissionofIndividualCaseSafetyReportsE2C(R2)PeriodicBenefit-RiskEvaluationReport第34页E2C(R2)-E2FE2C(R2)

Q&AsQuestions&Answers:PeriodicBenefit-RiskEvaluationReportE2D

Post-ApprovalSafetyData

Management:DefinitionsandStandardsforExpeditedReportingE2E

Pharmacovigilance

PlanningE2F

DevelopmentSafetyUpdateReport

第35页E3ClinicalStudyReports

临床研究汇报E3StructureandContentofClinicalStudyReportsE3Q&AsR1Questions&Answers:StructureandContentofClinicalStudyReports

第36页E4Dose-ResponseStudies

剂量反应研究E4Dose-ResponseInformationtoSupportDrugRegistration支持药品注册剂量反应信息第37页E5EthnicFactors民族原因

E5(R1)EthnicFactorsintheAcceptabilityofForeignClinicalDataE5Q&As(R1)Questions&Answers:EthnicFactorsintheAcceptabilityofForeignClinicalData第38页E6GoodClinicalPractice

临床试验规范E6(R1)GoodClinicalPracticeE6(R2)Addendum:GoodClinicalPractice

第39页E7ClinicalTrialsinGeriatricPopulation

在老年人群中临床试验

E7StudiesinSupportofSpecialPopulations:GeriatricsE7Q&AsQuestions&Answers:StudiesinSupportofSpecialPopulations:Geriatrics第40页

E8GeneralConsiderationsforClinicalTrials

临床试验普通考虑

E8GeneralConsiderationsforClinicalTrials第41页E9StatisticalPrinciplesforClinicalTrials

临床试验统计学原理

E9StatisticalPrinciplesforClinicalTrials

E9(R1)Addendum:StatisticalPrinciplesforClinicalTrials第42页E10ChoiceofControlGroupinClinicalTrials临床试验中对照组选择

E10ChoiceofControlGroupandRelatedIssuesinClinicalTrials在临床试验中对照组和相关问题选择第43页E11ClinicalTrialsinPediatricPopulation在儿科临床试验

E11ClinicalInvestigationofMedicinalProductsinthePediatricPopulation

E11(R1)Addendum:ClinicalInvestigationofMedicinalProductsinthePediatricPopulation第44页E12ClinicalEvaluationbyTherapeuticCategory治疗类别临床评价

E12PrinciplesforClinicalEvaluationofNewAntihypertensiveDrugs第45页E14ClinicalEvaluation临床评价E14TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs

E14Q&AsR2Questions&Answers:TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs第46页E15DefinitionsinPharmacogenetics/Pharmacogenomics药理学/药品基因组学定义

E15DefinitionsforGenomicBiomarkers,Pharmacogenomics,Pharmacogenetics,GenomicDataandSampleCodingCategories第47页E16QualificationofGenomicBiomarkers

基因组生物标志物资格

E16BiomarkersRelatedtoDrugorBiotechnologyProductDevelopment:Context,StructureandFormatofQualificationSubmissions药品或生物技术产品开发相关生物标志物：上下文，结构和资格文件格式第48页E17Multi-RegionalClinicalTrials多区域临床试验

E17Generalprincipleonplanning/designingMulti-RegionalClinicalTrials在规划/设计多区域临床试验普通标准第49页E18GenomicSamplingMethodologies

基因组取样方法

E18GenomicSamplingMethodologiesforFutureUse第50页Cross-cuttingTopicsCross-cuttingGuidelines

第51页四、MultidisciplinaryGuidelines

多学科指南

Thosearethecross-cuttingtopicswhichdonotfituniquelyintooneoftheQuality,SafetyandEfficacycategories.Itincludes