ICHM7(step4)基因毒性杂质评估和控制◆中英.docVIP

ASSESSMENT AND CONTROL OF DNA REACTIVE(MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TOLIMITPOTENTIAL 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 Curre nt 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 accordanee with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the Europea n Union, Japa n and USA. M7 Docume nt History 文件历史 Code文件代码 History 历史 Date 日期 M7 Approval by the Steeri ng Committee un der Step 2 and release for public con sultati on. 第2阶段由筹委会批准，公开征求意见 6 February 2013 M7 Approval by the Steeri ng Committee un der 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 Corrige ndum 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 maybe used, reproduced, in corporated into other works, adapted, modified, tran slated or distributed un der a public lice nse provided that ICHs copyright in the docume nt is ack no wledged at all times. In case of any adaption, modification or translation of the document, reas on able steps must be take n to clearly label, demarcate or otherwise ide ntify that cha nges were made to or based on the origi nal docume nt. Any impressi on that the adapti on, modificati on or tran slati on of the origi nal docume nt is en dorsed or spon sored by the ICH must be avoided.The docume nt is provided as is without warra nty of any kind. In no eve nt shall the ICH or the authors of the origi nal docume nt 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