20140723 ECA新闻：ICH M7基因毒性杂质指南终版公布

        20140723 ECA新闻：         ICH M7基因毒性杂质指南终版公布  

2014-07-24 09:44:52|  分类： ECA新闻 |  

原文网址：http://www.gmp-compliance.org/enews_4416_Final%20ICH%20M7%20Guideline%20on%20Genotoxic%20Impurities%20published_8559,8500,S-QSB_n.html

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Final ICH M7 Guideline on Genotoxic Impurities published

ICH M7基因毒性杂质指南终版公布

On 15 July 2014, the ICH issued the guideline M7 "Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk" as Step 4 document. In the last step of the ICH process (Step 5) this guideline now has to be implemented in the national regulations in the three ICH regions Europe, United States and Japan. The final M7 Guideline was published exactly 17 months after the release of the draft consensus guideline (Step 2) in February 2013, where it could be commented in a 6-month period.

2014年7月15日，ICH签发了M7指南“”，其为第4阶段文件，目前要求ICH区域内国家实施。最终的M7指南是在2013年2月份的草案（第2阶段）发布后整整17个月才公布的，而征求意见其实可以在6个月完成的。

The guideline comprises information, how impurities in pharmaceutical products relative to their genotoxic potential have to be evaluated with the analysis of structure-activity relationships and how the critical toxicological threshold (threshold of toxicological concern TTC) has to be determined. In the individual chapters, some highly complex issues and scenarios are covered - as, for instance, the question why potentially genotoxic substances with similar molecular structure and probably the same mechanism of action should still not be combined for the calculation of the TTC. Another problem the Guideline tries to clarify is the different values of the TTC, depending on the duration of the use of the medicinal product.

指南中包括如何根据结构活性分析来评估药品中杂质的潜在基因毒性，如何确定关键毒性阈值（毒性关注阈值TTC）。在一个独立的章节中，论述了一些特别复杂的问题和情景，例如，为什么潜在基因毒性物质具有相似的分子结构，可能相同的反应机理还不能合并用于TTC的计算。另一个问题是指南试图对不同TTC值进行澄清，这依赖于使用药品的时间长度。

The last section of the document contains a statement of the ICH, that due to its complexity the guideline has to be implemented in the respective national rules and regulations after 18 months only. However, the following exceptions apply to some requests:

文件最后一部分包括一个ICH的声明，由于指南比较复杂，因此在不同国家法律法规中实施只能是在18个月之后。但是，以下要求适用于某些申请：

For the implementation of Ames tests the specifications of M7 have to be applied immediately. However, the Ames tests carried out before release of M7 need not be repeated.  所有AMES测试，必须立即实施M7标准。但是，在M7出版前所进行的AMES测试不必重复。 The development programmes having started phase 2b/3 prior to publication of M7 can be continued. The requirements for the execution of two quantitative analyses of structure-activity relations (section 6), for impurity assessment (section 5) and for the documentation (section 9) do not have to be considered, though.  在M7出版前已开始2b/3期研发的项目可以继续。实施2项结构活性关系定量分析（第6部分）、杂质评估（第5部分）和文件记录（第9部分）不是必须考虑的。 For a new marketing authorisation application which does not include the phase 2b/3 clinical trials, compliance with the aforementioned points is expected until 36 months after the publication of M7.  
• 如果一个新的上市许可申报中不包括2b/3阶段临床试验，则在M7出版后，要符合前述要求则要在36月之后
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Compared to the previous Guideline version (Step 2) it now contains changes, clarifications and precisions in several parts. For a more detailed analysis of the new M7 Guideline please see one of our next newsletters.

与之前的指南版本（第2版）相比，现在的版本包括了几个部分的变更、澄清和精确表达。对新的M7指南的详细分析参见我们下一期快讯。

The ECA will conduct the Impurities Forum 2014in Berlin, where a complete day will be dedicated to the implementation of Genotoxic Impurities ICH M7. On another day you will cover the implementation of Elemental Impurities ICH Q3D - whose finalisation is scheduled for September. The days can be booked separately or alternatively the entire 3 days of the Impurities Forum.

ECA将在2014年在柏林举办杂质论坛，其中会用一整天专门讨论M7基因毒性杂质的实施，另一天则是ICH Q3D元素杂质的实施----该指南计划在9月份定稿。该论坛可以分开预订，也可以参加整个3天的杂质论坛。

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