ICH指導(dǎo)原則目錄

QualityGuidelines（質(zhì)量）編號階段發(fā)布日期內(nèi)容Q1Stability（穩(wěn)定性）Q1A(R2)Step52003-2-6StabilityTestingofNewDrugSubstancesandProducts新原料藥和制劑的穩(wěn)定性試驗Q1BStep51996-11-6StabilityTesting:PhotostabilityTestingofNewDrugSubstancesandProducts穩(wěn)定性試驗：新原料藥和制劑的光穩(wěn)定性試驗Q1CStep51996-11-6StabilityTestingforNewDosageForms穩(wěn)定性試驗：新劑型的要求Q1DStep52002-2-7BracketingandMatrixingDesignsforStabilityTestingofNewDrugSubstancesandProducts新原料藥和制劑穩(wěn)定性試驗的括號法和矩陣法設(shè)計Q1EStep52003-2-6EvaluationofStabilityData穩(wěn)定性數(shù)據(jù)的評價Q1F廢止廢止時間:2006-6-8StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV氣候帶III和IV注冊申請的穩(wěn)定性數(shù)據(jù)包Q2AnalyticalValidation（分析方法驗證）Q2(R1)Step52005-11ValidationofAnalyticalProcedures:TextandMethodology分析方法驗證：文本及方法學(xué)Q3Impurities（雜質(zhì)）Q3A(R2)Step52006-10-25ImpuritiesinNewDrugSubstances新原料藥中的雜質(zhì)Q3B(R2)Step52006-6-2ImpuritiesinNewDrugProducts新藥制劑中的雜質(zhì)Q3C(R6)Step52016-10-20Impurities:GuidelineforResidualSolvents雜質(zhì)：殘留溶劑指南Q3DStep52014-12-16GuidelineforElementalImpurities元素雜質(zhì)指南Q4Pharmacopoeias（藥典）Q4Pharmacopoeias藥典Q4APharmacopoeialHarmonisation藥典的同一化Q4BStep52007-11-1EvaluationandRecommendationofPharmacopoeialTextsforUseintheICHRegionsICH各地區(qū)使用的藥典正文評估和建議Q4BAnnex1(R1)Step52010-9-27ResidueonIgnition/SulphatedAshGeneralChapter關(guān)于ICH區(qū)域內(nèi)藥典附錄的評價及建議-熾灼殘渣（硫酸灰分）檢查法Q4BAnnex2(R1)Step52010-9-27TestforExtractableVolumeofParenteralPreparationsGeneralChapter關(guān)于ICH區(qū)域內(nèi)藥典附錄的評價及建議-注射劑裝量檢查法Q4BAnnex3(R1)Step52010-9-27TestforParticulateContamination:Sub-VisibleParticlesGeneralChapter關(guān)于ICH區(qū)域內(nèi)藥典附錄的評價及建議-不溶性微粒檢查法生物技術(shù)產(chǎn)品的質(zhì)量：rDNA衍生蛋白質(zhì)產(chǎn)品生產(chǎn)細胞的表達構(gòu)建體分析Q5CStep51995-11-30QualityofBiotechnologicalProducts:StabilityTestingofBiotechnological/BiologicalProducts生物技術(shù)產(chǎn)品的質(zhì)量：生物制品/生物技術(shù)產(chǎn)品的穩(wěn)定性試驗Q5DStep51997-7-16DerivationandCharacterisationofCellSubstratesUsedforProductionofBiotechnological/BiologicalProducts用于生物技術(shù)產(chǎn)品及生物制品生產(chǎn)的細胞基質(zhì)的來源和鑒定Q5EStep52004-11-18ComparabilityofBiotechnological/BiologicalProductsSubjecttoChangesintheirManufacturingProcess生物技術(shù)產(chǎn)品/生物制品在工藝變更時的可比性Q6Specifications（質(zhì)量標準）Q6AStep51999-10-6Specifications:TestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProducts:ChemicalSubstances質(zhì)量標準新原料藥和制劑的檢測以及可接受標準：化學(xué)物質(zhì)Q6BStep51999-3-10Specifications:TestProceduresandAcceptanceCriteriaforBiotechnological/BiologicalProducts質(zhì)量標準：生物技術(shù)產(chǎn)品以及生物制品的檢測方法和可接受標準Q7GoodManufacturingPractice（生產(chǎn)質(zhì)量管理規(guī)范）Q7Step52000-11-10GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients原料藥生產(chǎn)的GMP指南Q7Q&AsStep52015-6-10QuestionsandAnswers:GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients原料藥生產(chǎn)的GMP指南的問與答Q8PharmaceuticalDevelopment（藥品研發(fā)）Q8(R2)Step52009-8PharmaceuticalDevelopment藥品研發(fā)Q9QualityRiskManagement（質(zhì)量風險管理）Q9Step52005-11-9QualityRiskManagement質(zhì)量風險管理Q10PharmaceuticalQualitySystem（藥物質(zhì)量體系）Q10Step52008-6-4PharmaceuticalQualitySystem藥品質(zhì)量體系Q8/9/10Q&As(R4)Step5Q8/Q9/Q10QuestionsandAnswersQ8，Q9，Q10的問與答Q11DevelopmentandManufactureofDrugSubstances（原料藥的研發(fā)和生產(chǎn)）Q11Step52012-5-1DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechnological/BiologicalEntities)藥物的研發(fā)和生產(chǎn)（化學(xué)實體和生物技術(shù)產(chǎn)品/生物制品實體）Q11Q&AsStep42017-8-23Questions&Answers:SelectionandJustificationofStartingMaterialsfortheManufactureofDrugSubstancesQ11的問與答Q12LifecycleManagement（生命周期管理）Q12Step2TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagement藥品生命周期的技術(shù)和監(jiān)管考慮SafetyGuidelines（安全性）編號階段發(fā)布日期內(nèi)容S1CarcinogenicityStudies（致癌性研究）S1AStep51995-11-29NeedforCarcinogenicityStudiesofPharmaceuticals藥物致癌試驗的必要性S1BStep51997-07-16TestingforCarcinogenicityofPharmaceuticals藥物致癌試驗S1C(R2)Step52008-03-11DoseSelectionforCarcinogenicityStudiesofPharmaceuticals藥物致癌試驗的劑量選擇S2GenotoxicityStudies（遺傳毒性研究）S2(R1)Step52011-11-09GuidanceonGenotoxicityTestingandDataInterpretationforPharmaceuticalsIntendedforHumanUse人用藥物的遺傳毒性試驗和數(shù)據(jù)分析指導(dǎo)原則S3ToxicokineticsandPharmacokinetics（毒代動力學(xué)和藥代動力學(xué)）S3AStep51994-10-27NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposureinToxicityStudies毒代動力學(xué)指導(dǎo)原則：毒性研究中全身暴露的評價S3AQ&AsStep52017-11-16QuestionsandAnswers:NoteforGuidanceonToxicokinetics:TheAssessmentofSystemicExposure-FocusonMicrosamplingS3A問與答S3BStep51994-10-27Pharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies藥代動力學(xué)：重復(fù)給藥的組織分布研究指導(dǎo)原則S4ToxicityTesting（毒性試驗）S4Step51998-09-02DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting)動物慢性毒性試驗的周期（嚙齒類和非嚙齒類）S5ReproductiveToxicology（生殖毒性）S5(R2)Step52005-11DetectionofToxicitytoReproductionforMedicinalProducts&ToxicitytoMaleFertility藥物生殖毒性和雄性生育力毒性的檢測S5(R3)Step3RevisionofS5GuidelineonDetectionofToxicitytoReproductionforHumanPharmaceuticals關(guān)于S5中人用藥物生殖毒性檢測的修訂S6BiotechnologicalProducts（生物技術(shù)藥品）S6(R1)Step52011-6PreclinicalSafetyEvaluationofBiotechnology-DerivedPharmaceuticals生物技術(shù)藥品的臨床前安全性試驗S7PharmacologyStudies（藥理學(xué)研究）S7AStep52000-11-8SafetyPharmacologyStudiesforHumanPharmaceuticals人用藥物的安全性藥理學(xué)研究S7BStep52005-5-12TheNon-ClinicalEvaluationofthePotentialforDelayedVentricularRepolarization(QTIntervalProlongation)byHumanPharmaceuticals人用藥延遲心室復(fù)極化（QT間期延長）潛在作用的非臨床評價指導(dǎo)原則S8ImmunotoxicologyStudies（免疫毒性研究）S8Step52005-9-15ImmunotoxicityStudiesforHumanPharmaceuticals人用藥品的免疫毒性研究S9NonclinicalEvaluationforAnticancerPharmaceuticals（抗癌藥物的非臨床研究）S9Step52009-10-29NonclinicalEvaluationforAnticancerPharmaceuticals抗癌藥物的非臨床評價S9Q&AsStep3QuestionsandAnswers:NonclinicalEvaluationforAnticancerPharmaceuticals抗癌藥物非臨床評價的問與答S10PhotosafetyEvaluation（光安全性研究）S10Step52013-11-13PhotosafetyEvaluationofPharmaceuticals藥物的光安全性評價S11NonclinicalSafetyTesting（非臨床安全性試驗）S11Step1NonclinicalSafetyTestinginSupportofDevelopmentofPaediatricMedicines支持兒科藥物研發(fā)的非臨床研究EfficacyGuidelines（有效性）編號階段發(fā)布日期內(nèi)容E1ClinicalSafetyforDrugsusedinLong-TermTreatment（長期用藥的臨床安全性）E1Step51994-10-27TheExtentofPopulationExposuretoAssessClinicalSafetyforDrugsIntendedforLong-TermTreatmentofNon-LifeThreateningConditions對非危及生命的疾病的長期治療藥物進行臨床安全性評估的人群暴露程度E2Pharmacovigilance（藥物警戒）E2AStep51994-10-27ClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting臨床安全性數(shù)據(jù)管理：快速報告的定義和標準E2B(R3)Step52015-4ClinicalSafetyDataManagement:DataElementsforTransmissionofIndividualCaseSafetyReports臨床安全性數(shù)據(jù)管理：個體病例安全性報告?zhèn)鬟f的數(shù)據(jù)要素E2B(R3)IWGStep52016-6-16Implementation:ElectronicTransmissionofIndividualCaseSafetyReports關(guān)于E2B(R3)實施的問與答E2C(R2)Step52012-12-17PeriodicBenefit-RiskEvaluationReport上市藥品定期風險效益評估報告E2C(R2)Q&AsStep52014-3-31Questions&Answers:PeriodicBenefit-RiskEvaluationReport上市藥品定期風險效益評估報告的問與答E2DStep52003-11-12Post-ApprovalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting批準后的安全數(shù)據(jù)管理：快速報告的定義和標準E2EStep52004-11-18PharmacovigilancePlanning藥物警戒計劃E2FStep52010-8-17DevelopmentSafetyUpdateReport研發(fā)安全性更新報告E3ClinicalStudyReports（臨床研究報告）E3Step51995-11-30StructureandContentofClinicalStudyReports臨床研究報告的結(jié)構(gòu)與內(nèi)容E3Q&As(R1)Step52012-7-6Questions&Answers:StructureandContentofClinicalStudyReports臨床研究報告的結(jié)構(gòu)與內(nèi)容問與答E4Dose-ResponseStudies（量-效關(guān)系研究）E4Step51994-3-10Dose-ResponseInformationtoSupportDrugRegistration新藥注冊所需的量-效關(guān)系資料E5EthnicFactors（種族因素）E5(R1)Step51998-2-5EthnicFactorsintheAcceptabilityofForeignClinicalData引入海外臨床數(shù)據(jù)時要考慮的種族因素E5Q&As(R1)Step52006-6-2Questions&Answers:EthnicFactorsintheAcceptabilityofForeignClinicalData引入海外臨床數(shù)據(jù)時要考慮的種族因素的問與答E6GoodClinicalPractice（藥物臨床研究質(zhì)量管理規(guī)范）E6(R2)Step52016-11-9藥物臨床研究規(guī)范GoodClinicalPractice（GCP）E7ClinicalTrialsinGeriatricPopulation（老年人群的臨床試驗）E7Step51993-6-24StudiesinSupportofSpecialPopulations:Geriatrics老年人群的臨床研究E7Q&AsStep52010-7-6Questions&Answers:StudiesinSupportofSpecialPopulations:Geriatrics老年人群的臨床研究的問與答E8GeneralConsiderationsforClinicalTrials（臨床試驗的一般考慮）E8Step51997-7-17GeneralConsiderationsforClinicalTrials臨床試驗的一般考慮E8(R1)Step1RevisiononGeneralConsiderationsforClinicalTrials臨床試驗一般考慮的修訂E9StatisticalPrinciplesforClinicalTrials（臨床試驗的統(tǒng)計原則）E9Step51998-2-5StatisticalPrinciplesforClinicalTrials臨床試驗統(tǒng)計原則E9(R1)Step3Addendum:StatisticalPrinciplesforClinicalTrialsE9附錄E10ChoiceofControlGroupinClinicalTrials（臨床試驗中對照組的選?。〦10Step52000-7-20ChoiceofControlGroupandRelatedIssuesinClinicalTrials臨床試驗的對照組選擇及相關(guān)問題E11ClinicalTrialsinPediatricPopulation（兒童用藥品的臨床試驗）E11Step52000-7-20ClinicalInvestigationofMedicinalProductsinthePediatricPopulation兒童用藥品的臨床調(diào)查E11(R1)Step52017-7-20Addendum:ClinicalInvestigationofMedicinalProductsinthePediatricPopulationE11附錄E11AStep1PaediatricExtrapolation兒科外推E12ClinicalEvaluationbyTherapeuticCategory（新抗高血壓藥的臨床評價）E12Step52000-3-2PrinciplesforClinicalEvaluationofNewAntihypertensiveDrugs新抗高血壓藥的臨床評價原則E14ClinicalEvaluationofQT（QT臨床評價）E14Step52005-5-12TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugs非抗心律失常藥物致QT/QTc間期延長及潛在心律失常作用的臨床評價E14Q&As(R3)Step52015-12-10Questions&Answers:TheClinicalEvaluationofQT/QTcIntervalProlongationandProarrhythmicPotentialforNon-AntiarrhythmicDrugsE14的問與答E14/S7BStep1DiscussionGrouponClinicalandnon-ClinicalEvaluationofQT/QTcIntervalProlongationQT/QTc間期延長的臨床和非臨床評價討論組E15DefinitionsinPharmacogenetics/Pharmacogenomics（藥物遺傳學(xué)/藥物基因組學(xué)的定義）E15Step52007-11-1DefinitionsforGenomicBiomarkers,Pharmacogenomics,Pharmacogenetics,GenomicDataandSampleCodingCategories基因組生物標記物、藥物基因組學(xué)、遺傳藥理學(xué)、基因組數(shù)據(jù)和樣本編碼分類的定義E16QualificationofGenomicBiomarkers（基因組生物標記物的條件）E16Step52010-8-20BiomarkersRelatedtoDrugorBiotechnologyProductDevelopment:Context,StructureandFormatofQualificationSubmissions與藥物或生物技術(shù)產(chǎn)品相關(guān)的生物標記物研發(fā):申請資料的內(nèi)容、結(jié)構(gòu)和格式E17Multi-RegionalClinicalTrials（國際多中心臨床試驗）E17Step52017-11-16Generalprincipleonplanning/designingMulti-RegionalClinicalTrials國際多中心臨床試驗計劃與設(shè)計原則E18GenomicSampling（基因組采樣）E18Step52017-8-3GenomicSamplingandManagementofGenomicData基因組樣品采集和基因組數(shù)據(jù)管理指南E19SafetyDataCollection（安全性數(shù)據(jù)收集）E19Step1OptimisationofSafetyDataCollection安全性數(shù)據(jù)收集的優(yōu)化MultidisciplinaryGuidelines（多學(xué)科綜合）編號階段發(fā)布日期內(nèi)容M1MedDRATerminology（監(jiān)管活動醫(yī)學(xué)術(shù)語）M1Version20.12017-9MedicalDictionaryforRegulatoryActivities(MedDRA)監(jiān)管活動醫(yī)學(xué)術(shù)語M2ElectronicStandards（電子標準）M2ElectronicStandardsfortheTransferofRegulatoryInformation(ESTRI)監(jiān)管信息傳輸電子標準M3NonclinicalSafetyStudies（非臨床安全性研究）M3(R2)Step52009-6-11GuidanceonNonclinicalSafetyStudiesfortheConductofHumanClinicalTrialsandMarketingAuthorizationforPharmaceuticals藥物進行人體臨床試驗和上市許可申請的非臨床安全性研究指導(dǎo)原則M3(R2)Q&As(R2)Step52012-3-5Questions&Answers:GuidanceonNon-ClinicalSafetyStudiesfortheConductofHumanClinicalTrialsandMarketingAuthorizationforPharmaceuticalsM3的問與答M4CommonTechnicalDocument（通用技術(shù)文件）M4TheCommonTechnicalDocument(CTD)通用技術(shù)文件M4(R4)Step52016-6-15OrganisationoftheCommonTechnicalDocumentForTheRegistrationofPharmaceuticalsforhumanuse人用藥物注冊申請的通用技術(shù)文件組織結(jié)構(gòu)M4Q(R1)Step52002-9-12TheCommonTechnicalDocumentfortheRegistationofPharmaceuticals