ICH M7step4)基因毒性杂质评估和控制◆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M7Current?Step 4?versiondated 23 June 2014This 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.?M7Document History?文件历史Code?文件代码History?历史Date?日期M7Approval 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 2013M7Approval 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 2014Current Step 4 version?现行版本第4阶段M7Corrigendum 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 document.The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a