最新ICH指导原则84122.ppt

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1、最新ICH指导原则84122最新ICH指导原则84122ICH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

2、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最新最新ICH指导原则指导原则84122HarmonisationachievementsintheQualityareaincludepivotalmilestonessuchastheconductofstabilitystudies,definingrelevantthresholdsforimpuritiestestingandamoreflexibleapproachtopharmaceuticalqualitybasedonGoodManufacturingPractice(GMP)riskmanageme

3、nt.最新最新ICH指导原则指导原则84122Q1A(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 BracketingandMatrixingDesignsforStabilityTestingofNewDrugSubstancesandProdu

4、cts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最新最新ICH指导原则指导原则84122Q2(R1)ValidationofAnalyticalProcedures:TextandMethodology分析程序的验证：正文及方法论最新最新ICH指导原则指导原则84122Q3A(R2)Impurities in New Drug S

5、ubstances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 最新最新ICH指导原则指导原则84122Q4 Pharmacopoeias药典 Q4A Pharmacopoeial Harmonisation药典的协调Q4B

6、 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 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

7、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 最新最新ICH指导原则指导原则84122Q4B Annex 4BR1MicrobiologicalExa

8、minationofNon-SterileProducts:TestsforSpecifiedMicro-OrganismsGeneralChapterQ4B Annex 4CR1MicrobiologicalExaminationofNon-SterileProducts:AcceptanceCriteriaforPharmaceuticalPreparationsandSubstancesforPharmaceuticalUseGeneralChapterQ4B Annex 5R1DisintegrationTestGeneralChapterQ4B Annex 6Uniformityof

9、DosageUnitsGeneralChapterQ4B Annex 7R2DissolutionTestGeneralChapterQ4B Annex 8R1SterilityTestGeneralChapter最新最新ICH指导原则指导原则84122Q4B Annex 9R1TabletFriabilityGeneralChapterQ4B Annex 10R1PolyacrylamideGelElectrophoresisGeneralChapterQ4B Annex 11CapillaryElectrophoresisGeneralChapterQ4B Annex 12Analytic

10、alSievingGeneralChapterQ4B Annex 13BulkDensityandTappedDensityofPowdersGeneralChapterQ4B Annex 14BacterialEndotoxinsTestGeneralChapterQ4B FAQsFrequentlyAskedQuestions最新最新ICH指导原则指导原则84122Q5A(R1)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 源于人或者动物

11、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

12、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 Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing

13、 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最新最新ICH指导原则指导原则84122Q6A 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 Pr

14、ocedures 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最新最新ICH指导原则指导原则84122Q7GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients活性药物成份的GMP指南Q7Q&AsQuestionsandAnswers:GoodManufacturingPracticeGuideforActivePharmaceutical

15、Ingredients最新最新ICH指导原则指导原则84122Q8(R2)PharmaceuticalDevelopment药物开发药物开发Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation最新最新ICH指导原则指导原则84122Q9QualityRiskManagementQ8/9/10Q&AsR4Q8/Q9/Q10-Implementation最新最新ICH指导原则指导原则84122Q10PharmaceuticalQualitySystem药物质量体系Q8/9/10Q&AsR4Q8/Q9/Q10-Implementation实施最新最新ICH指导原则指导原则841

16、22Q11DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechnological/BiologicalEntities)Q11Q&AsQuestions&Answers:SelectionandJustificationofStartingMaterialsfortheManufactureofDrugSubstances最新最新ICH指导原则指导原则84122Q12TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleMana

17、gement最新最新ICH指导原则指导原则84122Cross-cuttingGuidelines最新最新ICH指导原则指导原则84122ICHhasproducedacomprehensivesetofsafetyGuidelinestouncoverpotentialriskslikecarcinogenicity,genotoxicityandreprotoxicity.Arecentbreakthroughhasbeenanon-clinicaltestingstrategyforassessingtheQTintervalprolongationliability:thesingle

18、mostimportantcauseofdrugwithdrawalsinrecentyears.最新最新ICH指导原则指导原则84122S1RodentCarcinogenicityStudiesforHumanPharmaceuticalsS1ANeedforCarcinogenicityStudiesofPharmaceuticalsS1BTestingforCarcinogenicityofPharmaceuticalsS1C(R2)DoseSelectionforCarcinogenicityStudiesofPharmaceuticals最新最新ICH指导原则指导原则84122S2

19、(R1)Guidance on Genotoxicity 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;最新最新ICH指导原则指导原则84122S3A Note f

20、or 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 最新最新ICH指导原则指导原

21、则84122S4DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting)最新最新ICH指导原则指导原则84122S5(R2)DetectionofToxicitytoReproductionforMedicinalProducts&ToxicitytoMaleFertility最新最新ICH指导原则指导原则84122S6(R1)PreclinicalSafetyEvaluationofBiotechnology-DerivedPharmaceuticals最新最新ICH指导原则指导原则84122S7

22、ASafetyPharmacologyStudiesforHumanPharmaceuticalsS7BTheNon-ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)byHumanPharmaceuticals最新最新ICH指导原则指导原则84122S8ImmunotoxicityStudiesforHumanPharmaceuticals人类的药物免疫毒性研究最新最新ICH指导原则指导原则84122S9NonclinicalEvaluationforAntic

23、ancerPharmaceuticalsS9Q&AsQuestionsandAnswers:NonclinicalEvaluationforAnticancerPharmaceuticals最新最新ICH指导原则指导原则84122S10 Photosafety Evaluation of Pharmaceuticals药物的光安全评价最新最新ICH指导原则指导原则84122S11NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicines最新最新ICH指导原则指导原则84122Cross-cuttingGuideline

24、sSomeICHProductsdonotfituniquelyintooneoftheQuality,SafetyorEfficacycategories.ThoseProductscanbefoundundertheMulidisciplinarySection.最新最新ICH指导原则指导原则84122TheworkcarriedoutbyICHundertheEfficacyheadingisconcernedwiththedesign,conduct,safetyandreportingofclinicaltrials.Italsocoversnoveltypesofmedicines

25、derivedfrombiotechnologicalprocessesandtheuseofpharmacogenetics/genomicstechniquestoproducebettertargetedmedicines最新最新ICH指导原则指导原则84122E1 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

26、人群暴露程度最新最新ICH指导原则指导原则84122E2A 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 Transmission of Individual Case Safety Reports E

27、2C(R2)Periodic Benefit-Risk Evaluation Report 最新最新ICH指导原则指导原则84122E2C(R2)Q&AsQuestions&Answers:PeriodicBenefit-RiskEvaluationReportE2DPost-ApprovalSafetyDataManagement:DefinitionsandStandardsforExpeditedReportingE2EPharmacovigilancePlanningE2FDevelopmentSafetyUpdateReport最新最新ICH指导原则指导原则84122E3Struct

28、ureandContentofClinicalStudyReportsE3Q&AsR1Questions&Answers:StructureandContentofClinicalStudyReports最新最新ICH指导原则指导原则84122E4Dose-ResponseInformationtoSupportDrugRegistration支持药品注册的剂量反应信息最新最新ICH指导原则指导原则84122E5(R1)EthnicFactorsintheAcceptabilityofForeignClinicalDataE5Q&As(R1)Questions&Answers:EthnicFa

29、ctorsintheAcceptabilityofForeignClinicalData最新最新ICH指导原则指导原则84122E6(R1)GoodClinicalPracticeE6(R2)Addendum:GoodClinicalPractice最新最新ICH指导原则指导原则84122E7StudiesinSupportofSpecialPopulations:GeriatricsE7Q&AsQuestions&Answers:StudiesinSupportofSpecialPopulations:Geriatrics最新ICH指导原则84122E8 General Considerat

30、ions for Clinical Trials最新最新ICH指导原则指导原则84122E9StatisticalPrinciplesforClinicalTrialsE9(R1)Addendum:StatisticalPrinciplesforClinicalTrials最新最新ICH指导原则指导原则84122E10ChoiceofControlGroupandRelatedIssuesinClinicalTrials在临床试验中的对照组和相关问题的选择最新最新ICH指导原则指导原则84122E11ClinicalInvestigationofMedicinalProductsinthePe

31、diatricPopulationE11(R1)Addendum:ClinicalInvestigationofMedicinalProductsinthePediatricPopulation最新最新ICH指导原则指导原则84122E12PrinciplesforClinicalEvaluationofNewAntihypertensiveDrugs最新最新ICH指导原则指导原则84122E14TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs

32、E14Q&AsR2Questions&Answers:TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs最新最新ICH指导原则指导原则84122E15DefinitionsforGenomicBiomarkers,Pharmacogenomics,Pharmacogenetics,GenomicDataandSampleCodingCategories最新最新ICH指导原则指导原则84122E16BiomarkersRelatedtoDrugor

33、BiotechnologyProductDevelopment: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最新最新ICH指导原则指导原则84122E17 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 最新最新ICH指导原则指导原则84122E18GenomicSamplingMethodologiesfo

34、rFutureUse最新最新ICH指导原则指导原则84122Cross-cuttingGuidelines最新最新ICH指导原则指导原则84122Thosearethecross-cuttingtopicswhichdonotfituniquelyintooneoftheQuality,SafetyandEfficacycategories.ItincludestheICHmedicalterminology(MedDRA),theCommonTechnicalDocument(CTD)andthedevelopmentofElectronicStandardsfortheTransferof

35、RegulatoryInformation(ESTRI).最新最新ICH指导原则指导原则84122MedDRA Medical Dictionary for Regulatory Activities 最新最新ICH指导原则指导原则84122ESTRIElectronic 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最新最新ICH指导原则指导原则84122M3(R2)Guidance on Nonclinical Safety Studies for the Conduct of Human

36、 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 最新最新ICH指导原则指导原则84122CTDTheCommonTechnicalDocument最新最新ICH指导原则指导原则84122M5 Da

37、ta 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最新最新ICH指导原则指导原则84122M6 Virus and Gene Therapy Vector Shedding and Transmission 病毒和基因治疗载体脱落和传输 最新最新ICH指导原则指导原则84122M7AssessmentandControlofDNAReactive(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最新最新ICH指导原则指导原则84122ElectronicCommonTechnicalDocument(eCTD)电子通用技术文件（ECTD）