q1a(r2)-2003-新原料药及新制剂稳定性研究(中英文)

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1、StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHarmonisedTripartiteGuidelineStabilityTestingofNewDrugSubstancesandProductsQ1A(R2)CurrentStep4versiondated6F

2、ebruary2003ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.第20页共20页Stab

3、ilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)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.16September1992Q1Q1AApprovalb

4、ytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q1wasrenamedQ1A.27October1993Q1AQ1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep2andreleaseforpublicconsultation.7October1999Q1A(R1)Q1A(R)ApprovalbytheSteeringCommitteeofthefirs

5、trevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.8November2000Q1A(R1)CurrentStep4versionQ1A(R2)ApprovalbytheSteeringCommitteeofthesecondrevisiondirectlyunderStep4withoutfurtherpublicconsultation,toincludeconsequencesoftheadoptionofQ1F(StabilityDataPacka

6、geforRegistrationApplicationsinClimaticZonesIIIandIV),andrecommendationforadoptiontothethreeICHregulatorybodies.6February2003Q1A(R2)第20页共20页StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)CoverNoteforRevisionofQ1A(R)StabilityTestingofNewDrugSubstancesandProducts新

7、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.Theinter

8、mediatestorageconditionhasbeencha