ICH M7(step4)：诱变性杂质评估和控制-2016

《ICH M7(step4)：诱变性杂质评估和控制-2016》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、20140623ICHM7（step4)：诱变性杂质评估和控制（中英文1/3）  ASSESSMENTAND CONTROLOF DNAREACTIVE (MUTAGENIC)IMPURITIESINPHARMACEUTICALSTO LIMIT 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 versiondated23June2014ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWor

2、kingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA. M7DocumentHistory 文件历史Code 文件代码History 历史Date 日期M7ApprovalbytheSteeringCommitt

3、eeunderStep2andreleaseforpublicconsultation.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M7Corrigendumtofixtypographicalerrorsandreplac

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

5、providedthatICH'scopyrightinthedocumentisacknowledgedatalltimes.Incaseofanyadaption,modificationortranslationofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressionthattheadaption,modificat

6、ionortranslationoftheoriginaldocumentisendorsedorsponsoredbytheICHmustbeavoided.Thedocumentisprovided"asis"withoutwarrantyofanykind.InnoeventshalltheICHortheauthorsoftheoriginaldocumentbeliableforanyclaim,damagesorotherliabilityarisingfromtheuseofthedocument.Theabove-mentionedper

7、missionsdonotapplytocontentsuppliedbythirdparties.Therefore,fordocumentswherethecopyrightvestsinathirdparty,permissionforreproductionmustbeobtainedfromthiscopyrightholder.ASSESSMENTAND CONTROLOF DNAREACTIVE (MUTAGENIC)IMPURITIESINPHARMACEUTICALSTO LIMIT POTENTIAL CARCINOGENIC RIS

8、K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ICHHa