ICH Q1a_R2_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)CurrentStep4versiondat

2、ed6February2003ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.第1页共

3、20页StabilityTestingofNewDrugSubstancesandProducts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)DocumentHistoryFirstHistoryDateNewCodificationCodificationNovember2005Q1ApprovalbytheSteeringCommitteeunderStep2and16SeptemberQ1releaseforpublicconsultation.1992Q

4、1AApprovalbytheSteeringCommitteeunderStep4and27OctoberQ1ArecommendationforadoptiontothethreeICHregulatory1993bodies.Q1wasrenamedQ1A.Q1A(R)ApprovalbytheSteeringCommitteeofthefirstrevision7OctoberQ1A(R1)underStep2andreleaseforpublicconsultation.1999Q1A(R)ApprovalbytheSteeringCom

5、mitteeofthefirstrevision8NovemberQ1A(R1)underStep4andrecommendationforadoptiontothe2000threeICHregulatorybodies.CurrentStep4versionQ1A(R2)ApprovalbytheSteeringCommitteeofthesecondrevision6FebruaryQ1A(R2)directlyunderStep4withoutfurtherpublicconsultation,to2003includeconsequenc

6、esoftheadoptionofQ1F(StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV),andrecommendationforadoptiontothethreeICHregulatorybodies.第2页共20页StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)CoverNoteforRevisionofQ1A(R)StabilityTestingofNewDrug

7、SubstancesandProducts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”

8、这一指导原则而产生的，内容包括：1.Theintermediatestorageconditionhasbeenchang