ichm7(step4)基因毒性杂质评估和控制◆中英

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1、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 versiondated23June2014ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultati

2、onbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA. M7DocumentHistory 文件历史Code 文件代码History 历史Date 日期M7ApprovalbytheSteeringCommitteeunderStep2andreleaseforpubliccon

3、sultation.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阶段M7Corrigendumtofixtypographicalerrorsandreplaceword“degradants”with“degradat

4、ionproducts”throughoutthedocument.修正输入错误，将全文中“degradants”替换成“degradationproducts”.23June2014 LegalNotice: Thisdocumentisprotectedbycopyrightandmaybeused,reproduced,incorporatedintootherworks,adapted,modified,translatedordistributedunderapubliclicenseprovidedthatICH'scopyright

5、inthedocumentisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslationofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressionthattheadaption,modificationortranslationoftheo

6、riginaldocumentisendorsedorsponsoredbytheICHmustbeavoided.Thedocumentisprovided"asis"withoutwarrantyofanykind.InnoeventshalltheICHortheauthorsoftheoriginaldocumentbeliableforanyclaim,damagesorotherliabilityarisingfromtheuseofthedocument.Theabove-mentionedpermissionsdonotapply

7、tocontentsuppliedbythirdparties.Therefore,fordocumentswherethecopyrightvestsinathirdparty,permissionforreproductionmustbeobtainedfromthiscopyrightholder.ASSESSMENTAND CONTROLOF DNAREACTIVE (MUTAGENIC)IMPURITIESIN PHARMACEUTICALSTO LIMIT POTENTIALCARCINOGENIC RISK为限制潜在致癌风险而对药物

8、中DNA活性（诱变性）杂质进行的评估和控制ICHHarmonisedTripartiteGuidelineICH三方协调指南Having