最新ICH指导原则课件.ppt

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1、ICH GuidelinesICHGuidelines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

2、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、一、Quality Guidelines 质量研究指导原则质量研究指导原则HarmonisationachievementsintheQualityareaincludepivotalmilestonessuchastheconductofstabilitystudies,definingrelevantthresholdsforimpuritiestestingandamoreflexibleapproachtopharmaceuticalqualitybasedonGoodManufacturingPract

3、ice(GMP)riskmanagement.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 BracketingandMatrixingDesignsforStabilityTestingofNe

4、wDrugSubstancesandProducts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Q2 Analytical Validation分析验证分析验证Q2(R1)ValidationofAnalyticalProcedures:TextandMethodology分析程序的验证：正文及方法论Q3A-Q3D Impuriti

5、es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 Elemental Impurities Q4-Q4B Pharmacopoeias药典药典Q4 Pharmacopoeias药

6、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 关于灼烧残渣/灰分 常规篇Q4B Annex 2R1 Test for Extractable Volume of Parenteral Preparat

7、ions 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 Non-Sterile Products:Microbial Enumeration Tests General Chapter Q4-Q4B Pha

8、rmacopoeias药典药典Q4B Annex 4BR1MicrobiologicalExaminationofNon-SterileProducts:TestsforSpecifiedMicro-OrganismsGeneralChapterQ4B Annex 4CR1MicrobiologicalExaminationofNon-SterileProducts:AcceptanceCriteriaforPharmaceuticalPreparationsandSubstancesforPharmaceuticalUseGeneralChapterQ4B Annex 5R1Disinteg

9、rationTestGeneralChapterQ4B Annex 6UniformityofDosageUnitsGeneralChapterQ4B Annex 7R2DissolutionTestGeneralChapterQ4B Annex 8R1SterilityTestGeneralChapterQ4-Q4B Pharmacopoeias药典药典Q4B Annex 9R1TabletFriabilityGeneralChapterQ4B Annex 10R1PolyacrylamideGelElectrophoresisGeneralChapterQ4B Annex 11Capill

10、aryElectrophoresisGeneralChapterQ4B Annex 12AnalyticalSievingGeneralChapterQ4B Annex 13BulkDensityandTappedDensityofPowdersGeneralChapterQ4B Annex 14BacterialEndotoxinsTestGeneralChapterQ4B FAQsFrequentlyAskedQuestionsQ5A-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

11、 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 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

12、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 Used 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

13、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Q6A-Q6B Specifications规格规格Q6A Specifications:Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substan

14、ces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 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Q7 Good Manufacturing Practice(原料药原料药GMP规范规范)Q7GoodManufacturingPracticeGuid

15、eforActivePharmaceuticalIngredients活性药物成份的GMP指南Q7Q&AsQuestionsandAnswers:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredientsQ8 Pharmaceutical 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-ImplementationQ9 Quality Risk Management质量风险管理质量风险管理Q9QualityRis

16、kManagementQ8/9/10Q&AsR4Q8/Q9/Q10-ImplementationQ10 Pharmaceutical Quality System 药物质量体系药物质量体系Q10PharmaceuticalQualitySystem药物质量体系Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation实施Q11 Development and Manufacture of Drug Substances原料药研发与生产Q11DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechno

17、logical/BiologicalEntities)Q11Q&AsQuestions&Answers:SelectionandJustificationofStartingMaterialsfortheManufactureofDrugSubstancesQ12 Lifecycle Management生命周期管理Q12TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagementCross-cutting TopicsCross-cuttingGuidelines二、二、Safety Guide

18、lines 安全性评价指导原则安全性评价指导原则ICHhasproducedacomprehensivesetofsafetyGuidelinestouncoverpotentialriskslikecarcinogenicity,genotoxicityandreprotoxicity.Arecentbreakthroughhasbeenanon-clinicaltestingstrategyforassessingtheQTintervalprolongationliability:thesinglemostimportantcauseofdrugwithdrawalsinrecentye

19、ars.S1A-S1C Carcinogenicity Studies致癌性研究S1RodentCarcinogenicityStudiesforHumanPharmaceuticalsS1ANeedforCarcinogenicityStudiesofPharmaceuticalsS1BTestingforCarcinogenicityofPharmaceuticalsS1C(R2)DoseSelectionforCarcinogenicityStudiesofPharmaceuticalsS2 Genotoxicity Studies遗传毒性研究S2(R1)Guidance on Geno

20、toxicity Testing and Data Interpretation for 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;S3A-S3B Toxicokinetics and Pharmacokinetics毒代动力学和药

21、代动力学S3A Note for Guidance on Toxicokinetics: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

22、S4 Toxicity Testing毒性试验S4DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting)S5 Reproductive Toxicology生殖毒理学S5(R2)DetectionofToxicitytoReproductionforMedicinalProducts&ToxicitytoMaleFertilityS6 Biotechnological Products生物技术制品S6(R1)PreclinicalSafetyEvaluationofBiotechnology-De

23、rivedPharmaceuticalsS7A-S7B Pharmacology Studies药理学研究S7ASafetyPharmacologyStudiesforHumanPharmaceuticalsS7BTheNon-ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)byHumanPharmaceuticalsS8 Immunotoxicology Studies免疫毒理学研究S8ImmunotoxicityStudiesforHumanPharmace

24、uticals人类的药物免疫毒性研究S9 Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药物非临床评价S9NonclinicalEvaluationforAnticancerPharmaceuticalsS9Q&AsQuestionsandAnswers:NonclinicalEvaluationforAnticancerPharmaceuticalsS10 Photosafety Evaluation光安全评价S10 Photosafety Evaluation of Pharmaceuticals药物的光安全评价S11 Non

25、clinical Safety Testing非临床安全性试验S11NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicinesCross-cutting TopicsCross-cuttingGuidelinesSomeICHProductsdonotfituniquelyintooneoftheQuality,SafetyorEfficacycategories.ThoseProductscanbefoundundertheMulidisciplinarySection.三、三、Efficacy Guidelines

26、 有效性评价指导原则有效性评价指导原则TheworkcarriedoutbyICHundertheEfficacyheadingisconcernedwiththedesign,conduct,safetyandreportingofclinicaltrials.Italsocoversnoveltypesofmedicinesderivedfrombiotechnologicalprocessesandtheuseofpharmacogenetics/genomicstechniquestoproducebettertargetedmedicinesE1 Clinical Safety fo

27、r 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 Conditions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-E2F Pharmacovigilance药物警戒E2A Clinical Safety Data Management:Definitions an

28、d Standards for Expedited Reporting E2B(R3)Clinical Safety Data Management:Data Elements for Transmission of Individual Case Safety Reports E2B(R3)IWGImplementation:Electronic Transmission of Individual Case Safety Reports E2C(R2)Periodic Benefit-Risk Evaluation Report E2C(R2)-E2FE2C(R2)Q&AsQuestion

29、s&Answers:PeriodicBenefit-RiskEvaluationReportE2DPost-ApprovalSafetyDataManagement:DefinitionsandStandardsforExpeditedReportingE2EPharmacovigilancePlanningE2FDevelopmentSafetyUpdateReportE3 Clinical Study Reports临床研究报告E3StructureandContentofClinicalStudyReportsE3Q&AsR1Questions&Answers:StructureandC

30、ontentofClinicalStudyReportsE4 Dose-Response Studies剂量反应研究E4Dose-ResponseInformationtoSupportDrugRegistration支持药品注册的剂量反应信息E5 Ethnic Factors民族因素E5(R1)EthnicFactorsintheAcceptabilityofForeignClinicalDataE5Q&As(R1)Questions&Answers:EthnicFactorsintheAcceptabilityofForeignClinicalDataE6 Good Clinical Pr

31、actice临床试验规范E6(R1)GoodClinicalPracticeE6(R2)Addendum:GoodClinicalPracticeE7 Clinical Trials in Geriatric Population在老年人群中的临床试验E7StudiesinSupportofSpecialPopulations:GeriatricsE7Q&AsQuestions&Answers:StudiesinSupportofSpecialPopulations:GeriatricsE8 General Considerations for Clinical Trials临床试验的一般考虑

32、E8 General Considerations for Clinical TrialsE9 Statistical Principles for Clinical Trials临床试验的统计学原理E9StatisticalPrinciplesforClinicalTrialsE9(R1)Addendum:StatisticalPrinciplesforClinicalTrialsE10 Choice of Control Group in Clinical Trials临床试验中对照组的选择E10ChoiceofControlGroupandRelatedIssuesinClinicalT

33、rials在临床试验中的对照组和相关问题的选择E11 Clinical Trials in Pediatric Population在儿科临床试验E11ClinicalInvestigationofMedicinalProductsinthePediatricPopulationE11(R1)Addendum:ClinicalInvestigationofMedicinalProductsinthePediatricPopulationE12 Clinical Evaluation by Therapeutic Category治疗类别临床评价E12PrinciplesforClinicalE

34、valuationofNewAntihypertensiveDrugsE14 Clinical Evaluation临床评价E14TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugsE14Q&AsR2Questions&Answers:TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugsE15 Defi

35、nitions in Pharmacogenetics/Pharmacogenomics药理学/药物基因组学的定义E15DefinitionsforGenomicBiomarkers,Pharmacogenomics,Pharmacogenetics,GenomicDataandSampleCodingCategoriesE16 Qualification of Genomic Biomarkers基因组生物标志物的资格E16BiomarkersRelatedtoDrugorBiotechnologyProductDevelopment:Context,StructureandFormatof

36、QualificationSubmissions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E17 Multi-Regional Clinical Trials多多区域临床试验区域临床试验E17 General principle 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 E18 Genomic Sampling Methodologies 基因组取样方法基因组取样方法E18GenomicSamplingMethodologiesforFu

37、tureUseCross-cutting TopicsCross-cuttingGuidelines四、四、Multidisciplinary Guidelines多学科指南多学科指南Thosearethecross-cuttingtopicswhichdonotfituniquelyintooneoftheQuality,SafetyandEfficacycategories.ItincludestheICHmedicalterminology(MedDRA),theCommonTechnicalDocument(CTD)andthedevelopmentofElectronicStanda

38、rdsfortheTransferofRegulatoryInformation(ESTRI).M1 MedDRA Terminology常用医学名词常用医学名词（MedDRA）MedDRA Medical Dictionary for Regulatory Activities 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M3 Nonclinical Safety St

39、udies非非临床试验临床试验安全研究安全研究M3(R2)Guidance on Nonclinical 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 fo

40、r Pharmaceuticals M4 Common Technical Document通用通用技术文件技术文件(CTD)CTDTheCommonTechnicalDocumentM5 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M6 Gene Therapy 基因治疗基因治疗M6 Virus and Gene Therapy Vecto

41、r Shedding and Transmission 病毒和基因治疗载体脱落和传输 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M8 Electronic Common Technical Document(eCTD)ElectronicCommonTechnicalDocument(eCTD)电子通用技术文件（ECTD）