最新ICH指导原则

ICHGuidelines王震2015-02-01ICHGuidelines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：1.“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。2.“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-NEWQ3DImplementationofGuidelineforElementalImpuritiesQ4-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:MicrobialEnumerationTestsGeneralChapterQ4-Q4BPharmacopoeias药典Q4BAnnex4BR1MicrobiologicalExaminationofNon-SterileProducts:TestsforSpecifiedMicro-OrganismsGeneralChapterQ4BAnnex4CR1MicrobiologicalExaminationofNon-SterileProducts:AcceptanceCriteriaforPharmaceuticalPreparationsandSubstancesforPharmaceuticalUseGeneralChapterQ4BAnnex5R1DisintegrationTestGeneralChapterQ4BAnnex6UniformityofDosageUnitsGeneralChapterQ4BAnnex7R2DissolutionTestGeneralChapterQ4BAnnex8R1SterilityTestGeneralChapterQ4-Q4BPharmacopoeias药典Q4BAnnex9R1TabletFriabilityGeneralChapterQ4BAnnex10R1PolyacrylamideGelElectrophoresisGeneralChapterQ4BAnnex11CapillaryElectrophoresisGeneralChapterQ4BAnnex12AnalyticalSievingGeneralChapterQ4BAnnex13BulkDensityandTappedDensityofPowdersGeneralChapterQ4BAnnex14BacterialEndotoxinsTestGeneralChapterQ4BFAQsFrequentlyAskedQuestionsQ5A-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:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredientsQ8PharmaceuticalDevelopment药物开发Q8(R2)PharmaceuticalDevelopment药物开发Q8/9/10Q&AsR4Q8/Q9/Q10-ImplementationQ9QualityRiskManagement质量风险管理Q9QualityRiskManagementQ8/9/10Q&AsR4Q8/Q9/Q10-ImplementationQ10PharmaceuticalQualitySystem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:SelectionandJustificationofStartingMaterialsfortheManufactureofDrugSubstancesQ12LifecycleManagement生命周期管理Q12TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagementCross-cuttingTopicsCross-cuttingGuidelines二、SafetyGuidelines安全性评价指导原则ICHhasproducedacomprehensivesetofsafetyGuidelinestouncoverpotentialriskslikecarcinogenicity,genotoxicityandreprotoxicity.Arecentbreakthroughhasbeenanon-clinicaltestingstrategyforassessingtheQTintervalprolongationliability:thesinglemostimportantcauseofdrugwithdrawalsinrecentyears.S1A-S1CCarcinogenicityStudies致癌性研究S1RodentCarcinogenicityStudiesforHumanPharmaceuticalsS1ANeedforCarcinogenicityStudiesofPharmaceuticals