ich m7(step4)基因毒性杂质评估和控制◆中英

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1、实用标准文案ASSESSMENTAND CONTROLOF DNAREACTIVE(MUTAGENIC)IMPURITIESIN PHARMACEUTICALSTOLIMIT POTENTIAL CARCINOGENIC RISK为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和控制M7Current Step4 versiondated23June2014ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupan

2、dhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.精彩文档实用标准文案 M7DocumentHistory 文件历史Code 文件代码History 历史Date 日期M7Appr

3、ovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.第2阶段由筹委会批准，公开征求意见6February2013M7ApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.第4阶段由筹委会批准，推荐ICH三方药监局采用5June2014CurrentStep4version 现行版本第

4、4阶段M7Corrigendumtofixtypographicalerrorsandreplaceword“degradants”with“degradationproducts”throughoutthedocument.修正输入错误，将全文中“degradants”替换成“degradationproducts”.23June2014 LegalNotice: Thisdocumentisprotectedbycopyrightandmaybeused,reproduced,incorporated

5、intootherworks,adapted,modified,translatedordistributedunderapubliclicenseprovidedthatICH'scopyrightinthedocumentisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslationofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherw

6、iseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressionthattheadaption,modificationortranslationoftheoriginaldocumentisendorsedorsponsoredbytheICHmustbeavoided.精彩文档实用标准文案Thedocumentisprovided"asis"withoutwarrantyofanykind.Innoeventshall

7、theICHortheauthorsoftheoriginaldocumentbeliableforanyclaim,damagesorotherliabilityarisingfromtheuseofthedocument.Theabove-mentionedpermissionsdonotapplytocontentsuppliedbythirdparties.Therefore,fordocumentswherethecopyrightvestsinathirdparty,permissionfor

8、reproductionmustbeobtainedfromthiscopyrightholder.精彩文档实用标准文案ASSESSMENTAND CONTROLOF DNAREACTIVE (MUTAGENIC)IMPURITIESIN PHARMACEUTICALSTO LIMIT POTENTIALCARCINOGENIC RISK为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和控制ICHHarmonis