ICH M7(step4)基因毒性杂质评和控制◆中英.doc

ASSESSMENT AND?CONTROL OF?DNA REACTIVE(MUTAGENIC) IMPURITIES IN?PHARMACEUTICALS TOLIMIT?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. ? M7 Document History?文件历史 Code?文件代码 History?历史 Date?日期 M7 Approval by the Steering Committe