ICHM7（step4)基因毒性杂质评估和控制◆中英.doc

范文 范例 指导 参考 学习 资料 整理 分享 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 Committee under Step 2 and release for public consultation. 第2阶段由筹委会批准，公开征求意见 6 February 2013 M7 Approval by the Steering Committee under Step 4 and 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 5 June 2014 Current Step 4 version?现行版本第4阶段 M7 Corrigendum to fix typographical errors and replace word “degradants” with “degradation products” throughout the document. 修正输入错误，将全文中“degradants”替换成“degradation products”. 23 June 2014 ? 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 that ICHs copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided. The document is provided as is without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the docu