ICH-M7：you变性杂质评估和控制.pdfVIP

ICH M7 （step4)：诱变性杂质评估和控制 （翻译：zhuyujiao1972 ） ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO 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 M7 Current Step 4 version dated 23 June 2014 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 1 M7 Document History 文件历史 Code 文件代码 History 历史 Date 日期 M7 Approval by the Steering Committee under Step 2 and 6 February 2013 release for public consultation. 第2 阶段由筹委会批准，公开征求意见 M7 Approval by the Steering Committee under Step 4 and 5 June 2014 recommendation for adoption to the three ICH regulatory bodies. 第4 阶段由筹委会批准，推荐ICH 三方药监局采用 Current Step 4 version 现行版本第4 阶段 M7 Corrigendum to fix typographical errors and replace word 23 June 2014 “degradants” with “degradation products” throughout the document. 修正输入错误，将全文中“degradants ”替换成“degradation products ”. Legal Notice: This document is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided