ICH指导建议建议原则培训课件

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1、ICHICH指指导建建议建建议原原则ICHGuidelines2ICH指导建议建议原则说明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

2、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3ICH指导建议建议原则一、一、Quality Guidelines 质量研究指导原则质量研究指导原则HarmonisationachievementsintheQualityareaincludepivotalmilestonessuchastheconductofstabilitystudies,definingrelevantthresholdsforimpuritiestestingandamoreflexibleapproachtopharmaceuticalqualityb

3、asedonGoodManufacturingPractice(GMP)riskmanagement.4ICH指导建议建议原则Q1A-Q1F Stability稳定性稳定性Q1A(R2)StabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的稳定性试验Q1B StabilityTesting:PhotostabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的光稳定性试验Q1C StabilityTestingforNewDosageForms新剂型的稳定性试验Q1D Bracketingan

4、dMatrixingDesignsforStabilityTestingofNewDrugSubstancesandProducts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Q1F StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV在气候带III和IV，药物注册申请所提供的稳定性数据5ICH指导建议建议原则Q2 Analytical Validation分析验证分析验证Q2(R1)ValidationofAnalyticalProcedu

5、res:TextandMethodology分析程序的验证：正文及方法论6ICH指导建议建议原则Q3A-Q3D Impurities杂质杂质Q3A(R2)Impurities in New Drug Substances新原料药中的杂质Q3B(R2)Impurities in New Drug Products新制剂中的杂质Q3C(R5)Impurities:Guideline for Residual Solvents杂质：残留溶剂指南Q3D Guideline for Elemental Impurities-NEW Q3D Implementation of Guideline for

6、Elemental Impurities 7ICH指导建议建议原则Q4-Q4B Pharmacopoeias药典药典Q4 Pharmacopoeias药典 Q4A Pharmacopoeial Harmonisation药典的协调Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions药典内容的评估及推荐为用于药典内容的评估及推荐为用于ICH地区地区Q4B Annex 1R1 Residue on Ignition/Sulphated Ash General Chapter附录1 关

7、于灼烧残渣/灰分 常规篇Q4B Annex 2R1 Test for Extractable Volume of Parenteral Preparations General Chapter关于注射剂可提取容量测试关于注射剂可提取容量测试 常规篇常规篇Q4B Annex 3R1 Test for Particulate Contamination:Sub-Visible Particles General Chapter附录附录3 关于颗粒污染物测试关于颗粒污染物测试:不溶性微粒不溶性微粒 常规篇常规篇Q4B Annex 4AR1 Microbiological Examination of

8、 Non-Sterile Products:Microbial Enumeration Tests General Chapter 8ICH指导建议建议原则Q4-Q4B Pharmacopoeias药典药典Q4B Annex 4BR1MicrobiologicalExaminationofNon-SterileProducts:TestsforSpecifiedMicro-OrganismsGeneralChapterQ4B Annex 4CR1MicrobiologicalExaminationofNon-SterileProducts:AcceptanceCriteriaforPharma

9、ceuticalPreparationsandSubstancesforPharmaceuticalUseGeneralChapterQ4B Annex 5R1DisintegrationTestGeneralChapterQ4B Annex 6UniformityofDosageUnitsGeneralChapterQ4B Annex 7R2DissolutionTestGeneralChapterQ4B Annex 8R1SterilityTestGeneralChapter9ICH指导建议建议原则Q4-Q4B Pharmacopoeias药典药典Q4B Annex 9R1TabletFr

10、iabilityGeneralChapterQ4B Annex 10R1PolyacrylamideGelElectrophoresisGeneralChapterQ4B Annex 11CapillaryElectrophoresisGeneralChapterQ4B Annex 12AnalyticalSievingGeneralChapterQ4B Annex 13BulkDensityandTappedDensityofPowdersGeneralChapterQ4B Annex 14BacterialEndotoxinsTestGeneralChapterQ4B FAQsFreque

11、ntlyAskedQuestions10ICH指导建议建议原则Q5A-Q5E Quality of Biotechnological Products 生物技术产品的质量生物技术产品的质量Q5A(R1)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 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 Analysis of the Expression Construct in Cells

12、 Used for Production of r-DNA Derived Protein Products 生物技术产品的质量：源于重组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的蛋白质产品的生产中所用的细胞中的表达构建分析胞中的表达构建分析Q5C Stability Testing of Biotechnological/Biological Products 生物技术产品的质量：生物技术生物技术产品的质量：生物技术/生物产品的稳定性试验生物产品的稳定性试验Q5D Derivation and Characterisation of Cell Substrates Us

13、ed for Production of Biotechnological/Biological Products 用于生产生物技术用于生产生物技术/生物产品的细胞底物的起源和特征描述生物产品的细胞底物的起源和特征描述Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process 基于不同生产工艺的生物技术产品基于不同生产工艺的生物技术产品/生物产品的可比较性生物产品的可比较性11ICH指导建议建议原则Q6A-Q6B Specification

14、s规格规格Q6A Specifications:Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances质量规质量规格：新原料药和新制剂的检验程序和可接收标准：格：新原料药和新制剂的检验程序和可接收标准：化学物质化学物质(包括决定过程包括决定过程)Q6B Specifications:Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

15、 质量规格：生物技术质量规格：生物技术/生物产品的检验程序和可接生物产品的检验程序和可接收标准收标准12ICH指导建议建议原则Q7 Good Manufacturing Practice(原料药原料药GMP规范规范)Q7GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药物成份的GMP指南Q7Q&AsQuestionsandAnswers:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients13ICH指导建议建议原则Q8 Pharmace

16、utical Development药物开发药物开发Q8(R2)PharmaceuticalDevelopment药物开发药物开发Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation14ICH指导建议建议原则Q9 Quality Risk Management质量风险管理质量风险管理Q9QualityRiskManagementQ8/9/10Q&AsR4Q8/Q9/Q10-Implementation15ICH指导建议建议原则Q10 Pharmaceutical Quality System 药物质量体系药物质量体系Q10PharmaceuticalQualitySyst

17、em药物质量体系Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation实施16ICH指导建议建议原则Q11 Development and Manufacture of Drug Substances原料药研发与生产Q11DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechnological/BiologicalEntities)Q11Q&AsQuestions&Answers:SelectionandJustificationofStartingMaterialsfortheManufac

18、tureofDrugSubstances17ICH指导建议建议原则Q12 Lifecycle Management生命周期管理Q12TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagement18ICH指导建议建议原则Cross-cutting TopicsCross-cuttingGuidelines19ICH指导建议建议原则二、二、Safety Guidelines 安全性评价指导原则安全性评价指导原则ICHhasproducedacomprehensivesetofsafetyGuideli

19、nestouncoverpotentialriskslikecarcinogenicity,genotoxicityandreprotoxicity.Arecentbreakthroughhasbeenanon-clinicaltestingstrategyforassessingtheQTintervalprolongationliability:thesinglemostimportantcauseofdrugwithdrawalsinrecentyears.20ICH指导建议建议原则S1A-S1C Carcinogenicity Studies致癌性研究S1RodentCarcinoge

20、nicityStudiesforHumanPharmaceuticalsS1ANeedforCarcinogenicityStudiesofPharmaceuticalsS1BTestingforCarcinogenicityofPharmaceuticalsS1C(R2)DoseSelectionforCarcinogenicityStudiesofPharmaceuticals21ICH指导建议建议原则S2 Genotoxicity Studies遗传毒性研究S2(R1)Guidance on Genotoxicity Testing and Data Interpretation for

21、 Pharmaceuticals Intended for Human UseS2A:Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals;S2B:Genotoxicity:A Standard Battery for Genotoxicity Testing for Pharmaceuticals;22ICH指导建议建议原则S3A-S3B Toxicokinetics and Pharmacokinetics毒代动力学和药代动力学S3A Note for Guidance on To

22、xicokinetics:The Assessment of Systemic Exposure in Toxicity Studies S3A Q&AsQuestions and Answers:Note for Guidance on Toxicokinetics:The Assessment of Systemic Exposure-Focus on MicrosamplingS3B Pharmacokinetics:Guidance for Repeated Dose Tissue Distribution Studies 23ICH指导建议建议原则S4 Toxicity Testin

23、g毒性试验S4DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting)24ICH指导建议建议原则S5 Reproductive Toxicology生殖毒理学S5(R2)DetectionofToxicitytoReproductionforMedicinalProducts&ToxicitytoMaleFertility25ICH指导建议建议原则S6 Biotechnological Products生物技术制品S6(R1)PreclinicalSafetyEvaluationofBiotechn

24、ology-DerivedPharmaceuticals26ICH指导建议建议原则S7A-S7B Pharmacology Studies药理学研究S7ASafetyPharmacologyStudiesforHumanPharmaceuticalsS7BTheNon-ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)byHumanPharmaceuticals27ICH指导建议建议原则S8 Immunotoxicology Studies免疫毒理学研究S8Imm

25、unotoxicityStudiesforHumanPharmaceuticals人类的药物免疫毒性研究28ICH指导建议建议原则S9 Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药物非临床评价S9NonclinicalEvaluationforAnticancerPharmaceuticalsS9Q&AsQuestionsandAnswers:NonclinicalEvaluationforAnticancerPharmaceuticals29ICH指导建议建议原则S10 Photosafety Evaluation光安全评价

26、S10 Photosafety Evaluation of Pharmaceuticals药物的光安全评价30ICH指导建议建议原则S11 Nonclinical Safety Testing非临床安全性试验S11NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicines31ICH指导建议建议原则Cross-cutting TopicsCross-cuttingGuidelinesSomeICHProductsdonotfituniquelyintooneoftheQuality,SafetyorEfficacycat

27、egories.ThoseProductscanbefoundundertheMulidisciplinarySection.32ICH指导建议建议原则三、三、Efficacy Guidelines 有效性评价指导原则有效性评价指导原则TheworkcarriedoutbyICHundertheEfficacyheadingisconcernedwiththedesign,conduct,safetyandreportingofclinicaltrials.Italsocoversnoveltypesofmedicinesderivedfrombiotechnologicalprocesses

28、andtheuseofpharmacogenetics/genomicstechniquestoproducebettertargetedmedicines33ICH指导建议建议原则E1 Clinical Safety for Drugs used in Long-Term Treatment用于长期治疗药物的临床安全性E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Condition

29、s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34ICH指导建议建议原则E2A-E2F Pharmacovigilance药物警戒E2A Clinical Safety Data Management:Definitions and Standards for Expedited Reporting E2B(R3)Clinical Safety Data Management:Data Elements for Transmission of Individual Case Safety Reports E2B(R3)IWGImplementation:Electronic

30、 Transmission of Individual Case Safety Reports E2C(R2)Periodic Benefit-Risk Evaluation Report 35ICH指导建议建议原则E2C(R2)-E2FE2C(R2)Q&AsQuestions&Answers:PeriodicBenefit-RiskEvaluationReportE2DPost-ApprovalSafetyDataManagement:DefinitionsandStandardsforExpeditedReportingE2EPharmacovigilancePlanningE2FDeve

31、lopmentSafetyUpdateReport36ICH指导建议建议原则E3 Clinical Study Reports临床研究报告E3StructureandContentofClinicalStudyReportsE3Q&AsR1Questions&Answers:StructureandContentofClinicalStudyReports37ICH指导建议建议原则E4 Dose-Response Studies剂量反应研究E4Dose-ResponseInformationtoSupportDrugRegistration支持药品注册的剂量反应信息38ICH指导建议建议原则E

32、5 Ethnic Factors民族因素E5(R1)EthnicFactorsintheAcceptabilityofForeignClinicalDataE5Q&As(R1)Questions&Answers:EthnicFactorsintheAcceptabilityofForeignClinicalData39ICH指导建议建议原则E6 Good Clinical Practice临床试验规范E6(R1)GoodClinicalPracticeE6(R2)Addendum:GoodClinicalPractice40ICH指导建议建议原则E7 Clinical Trials in Ge

33、riatric Population在老年人群中的临床试验E7StudiesinSupportofSpecialPopulations:GeriatricsE7Q&AsQuestions&Answers:StudiesinSupportofSpecialPopulations:Geriatrics41ICH指导建议建议原则E8 General Considerations for Clinical Trials临床试验的一般考虑E8 General Considerations for Clinical Trials42ICH指导建议建议原则E9 Statistical Principles

34、for Clinical Trials临床试验的统计学原理E9StatisticalPrinciplesforClinicalTrialsE9(R1)Addendum:StatisticalPrinciplesforClinicalTrials43ICH指导建议建议原则E11 Clinical Trials in Pediatric Population在儿科临床试验E11ClinicalInvestigationofMedicinalProductsinthePediatricPopulationE11(R1)Addendum:ClinicalInvestigationofMedicinal

35、ProductsinthePediatricPopulation45ICH指导建议建议原则E12 Clinical Evaluation by Therapeutic Category治疗类别临床评价E12PrinciplesforClinicalEvaluationofNewAntihypertensiveDrugs46ICH指导建议建议原则E14 Clinical Evaluation临床评价E14TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDr

36、ugsE14Q&AsR2Questions&Answers:TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs47ICH指导建议建议原则E15 Definitions in Pharmacogenetics/Pharmacogenomics药理学/药物基因组学的定义E15DefinitionsforGenomicBiomarkers,Pharmacogenomics,Pharmacogenetics,GenomicDataandSampleCod

37、ingCategories48ICH指导建议建议原则E16 Qualification of Genomic Biomarkers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49ICH指导建议建议原则E17 Multi-Regional Clinical Trials多多区域临床试验区域临床试验E17 General princi

38、ple on planning/designing Multi-Regional Clinical Trials在规划在规划/设计设计多区域临床试验的一般原则多区域临床试验的一般原则 50ICH指导建议建议原则E18 Genomic Sampling Methodologies 基因组取样方法基因组取样方法E18GenomicSamplingMethodologiesforFutureUse51ICH指导建议建议原则Cross-cutting TopicsCross-cuttingGuidelines52ICH指导建议建议原则四、四、Multidisciplinary Guidelines多学

39、科指南多学科指南Thosearethecross-cuttingtopicswhichdonotfituniquelyintooneoftheQuality,SafetyandEfficacycategories.ItincludestheICHmedicalterminology(MedDRA),theCommonTechnicalDocument(CTD)andthedevelopmentofElectronicStandardsfortheTransferofRegulatoryInformation(ESTRI).53ICH指导建议建议原则M1 MedDRA Terminology常用

40、医学名词常用医学名词（MedDRA）MedDRA Medical Dictionary for Regulatory Activities 54ICH指导建议建议原则M2 Electronic Standards药政信息传递之电子标准药政信息传递之电子标准ESTRIElectronic Standards for the Transfer of Regulatory Information药政信息传递之药政信息传递之电子标准电子标准55ICH指导建议建议原则M3 Nonclinical Safety Studies非非临床试验安全研究临床试验安全研究M3(R2)Guidance on Nonc

41、linical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2)Q&As R2 Questions&Answers:Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 56ICH指导建议建议原则M4 Common Tech

42、nical Document通用通用技术文件技术文件(CTD)CTDTheCommonTechnicalDocument57ICH指导建议建议原则M5 Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准药物词典的数据要素和标准M5 Data Elements and Standards for Drug Dictionaries 药物词典的数据要素和标准药物词典的数据要素和标准58ICH指导建议建议原则M6 Gene Therapy 基因治疗基因治疗M6 Virus and Gene Therapy Vector Shed

43、ding and Transmission 病毒和基因治疗载体脱落和传输 59ICH指导建议建议原则M7 Genotoxic Impurities基因毒性杂质基因毒性杂质M7AssessmentandControlofDNAReactive(Mutagenic)ImpuritiesinPharmaceuticalstoLimitPotentialCarcinogenicRisk评估与DNA反应的控制（突变）的杂质在药品限制潜在的致癌风险60ICH指导建议建议原则M8 Electronic Common Technical Document(eCTD)ElectronicCommonTechnicalDocument(eCTD)电子通用技术文件（ECTD）61ICH指导建议建议原则