ICH-Q1a-R2-新原料药及新制剂稳定性研究-中英文-

StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)第1页共20页INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINESTABILITYTESTINGOFNEWDRUGSUBSTANCESANDPRODUCTSQ1A(R2)CurrentStep4versiondated6February2003ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)第2页共20页ICH指导原则新药物与新产品稳定性研究Q1A（R2）2003.2.6现行第4版Q1A(R2)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q1ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.16September1992Q1Q1AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q1wasrenamedQ1A.27October1993Q1AQ1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep2andreleaseforpublicconsultation.7October1999Q1A(R1)Q1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.8November2000Q1A(R1)CurrentStep4versionQ1A(R2)ApprovalbytheSteeringCommitteeofthesecondrevisiondirectlyunderStep4withoutfurtherpublicconsultation,toincludeconsequencesoftheadoptionofQ1F(StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV),andrecommendationforadoptiontothethreeICHregulatorybodies.6February2003Q1A(R2)StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)第3页共20页CoverNoteforRevisionofQ1A(R)StabilityTestingofNewDrugSubstancesandProducts新药物与新产品稳定性研究Q1A（R）修正说明ThepurposeofthisnoteistooutlinethechangesmadeinQ1A(R)thatresultfromadoptionofICHQ1F“StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV”.Thesechangesare:本注释的目的是概述R1A（R）的变化，这些变化是因采纳了ICHQ1F，即“在气候带III和IV地区注册申请的稳定性研究要求”这一指导原则而产生的，内容包括：1.Theintermediatestorageconditionhasbeenchangedfrom30°C±2°C/60%RH±5%RHto30°C±2°C/65%RH±5%RHinthefollowingsections:2.1.7.1DrugSubstance-StorageConditions-GeneralCase2.2.7.1DrugProduct-StorageConditions-GeneralCase2.2.7.3Drugproductspackagedinsemi-permeablecontainers3Glossary-“Intermediatetesting”下列章节中，中间放置环境由30±2/60%RH±5%℃℃修正为30±2/65%RH±5%℃℃2.1.7.1原料药-放置条件-一般情况2.2.7.1制剂-放置条件-一般情况2.2.7.3半渗透容器包装的制剂3术语-“中间试验”2.30°C±2°C/65%RH±5%RHcanbeasuitablealternativelong-termstorageconditionto25°C±2°C/60%RH±5%inthefollowingsections:2.1.7.1DrugSubstance-StorageConditions-GeneralCase2.2.7.1DrugProduct-StorageConditions-GeneralCase在下列章节中，30±2/65%RH±5%℃℃可作为长期试验放置条件25±2/60%RH±5%℃℃的合适替代条件：2.1.7.1原料药——放置条件——一般情况2.2.7.1制剂——放置条件——一般情况3.30°C±2°C/35%RH±5%RHhasbeenaddedasasuitablealternativelong-termstorageconditionto25°C±2°C/40%RH±5%andthecorrespondingexamplefortheratioofwater-lossrateshasbeenincludedinthefollowingsection:2.2.7.3Drugproductspackagedinsemi-permeablecontainers在下列章节中，30±2/35%RH±5%℃℃已作为长期放置条件5±2/40%RH±5%℃℃的合适替代条件，相应的计算失水率比值的例子已包括其中：2.2.7.3半渗透容器包装的制剂StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)第4页共20页Mid-streamswitchoftheintermediatestorageconditionfrom30°C±2°C/60%RH±5%RHto30°C±2°C/65%RH±5%RHcanbeappropriateprovidedthattherespectivestorageconditionsandthedateoftheswitchareclearlydocumentedandstatedintheregistrationapplication.中间放置条件可从30±2/60%RH±5%℃℃转为30±2/65%RH±5%℃℃，但必须清楚记录转换前后的放置条件和转换日期并在注册申请中阐明。Itisrecommendedthatregistrationapplicationscontaindatafromcompletestudiesattheintermediatestoragecondition30°C±2°C/65%RH±5%RH,ifapplicable,bythreeyearsafterthedateofpublicationofthisrevisedguidelineintherespectiveICHtripartiteregion.本修正指南颁布三年内，建议向各ICH机关提交的注册申请内容包括中间放置条件30±2/65%RH±5%℃℃的全部试验数据。StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)第5页共20页TABLEOFCONTENTS目录1.INTRODUCTION引言...............................................................................................61.1.ObjectivesoftheGuideline目的...................................................................................61.2.ScopeoftheGuideline范围.........................................................................................61.3.GeneralPrinciples通则................................................................................................72.GUIDELINES指导原则.............................................................................................72.1.DrugSubstance原料药................................................................................................72.1.1.General通则.....................................................................................................72.1.2.StressTesting影响因素试验...........................................................................72.1.3.SelectionofBatches批的选择.........................................................................82.1.4.ContainerClosureSystem包装容器................................................................92.1.5.Specification规范.............................................................................................92.1.6.Test