q1a(r2)-2003-新原料药与新制剂稳定性研究方案(中英文)

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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHarmonisedTripartiteGuidelineStabilityTestingofNewDrugSubstancesandProductsQ1A(R2)CurrentStep4versiondated6February2003ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWo

2、rkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.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)DocumentHistoryFirstCodificationHi

3、storyDateNewCodificationNovember2005Q1ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.16September1992Q1Q1AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q1wasrenamedQ1A.27October1993Q1AQ1A(R)ApprovalbytheSte

4、eringCommitteeofthefirstrevisionunderStep2andreleaseforpublicconsultation.7October1999Q1A(R1)Q1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.8November2000Q1A(R1)CurrentStep4versionQ1A(R2)ApprovalbytheSteering

5、CommitteeofthesecondrevisiondirectlyunderStep4withoutfurtherpublicconsultation,toincludeconsequencesoftheadoptionofQ1F(StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV),andrecommendationforadoptiontothethreeICHregulatorybodies.6February2003Q1A(R2)CoverNoteforR

6、evisionofQ1A(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

7、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-GeneralCase2.2.7.3Drugproducts

8、packagedinsemi-permeableco