现有CEP的ICH M7实施信息

EDQM新闻 现有CEP的ICH M7实施信息  

Information on the implementation of ICH M7 on existing CEPs

现有CEP的ICH M7实施信息

The guideline ICH M7 on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has been adopted by the CHMP and has been in force in the EU since January 2016. It is not to be applied retrospectively, therefore no action will be taken by EDQM on existing CEP applications and the established limits for mutagenic impurities will not be reviewed, unless requested by the CEP holder.

ICH M7指南“药物中DNA活性（诱变）杂质的评估和控制以限制潜在癌变风险”已经由CHMP采纳，自2016年1月开始在EU实施。该指南不会追溯既往，因此EDQM不会对现有CEP申报采取措施，除非CEP持有人要求，否则不会对所建立的诱变杂质限度进行审核。

Applicants have the possibility to reconsider their control strategy for mutagenic impurities in line with ICH M7 by submitting an appropriate request for revision, or an update included within a request for quinquennial renewal of their CEP.

申报者可以重新考虑重新提交适当的修订申请，使其对诱变杂质的控制策略符合ICH M7要求，或者在其CEP五年更新的申报中包括此更新。

The changes should be declared in accordance with the EDQM Guideline on requirements for revision/renewals (PA/PH/CEP (04) 2), and the following changes should be submitted as a minor revision (by default) provided they are not the consequence of other changes made to the manufacturing process of the substance:

如果该变更不是原料药生产工艺变更所引起的，则变更应根据EDQM“CEP修订/更新要求指南（PA/PH/CEP(04)2）”进行申报，以下变更应作为轻微变更（默认）进行提交：

• deletion / widening of a limit for a mutagenic impurity in the final substance specification  where the control strategy is in line  with the principles and limits of the ICH M7 guideline
• 删除/放宽最终原料药质量标准中的诱变杂质限度，使控制策略与ICH M7指南中的原则和限度一致
• deletion / widening of a limit for a mutagenic impurity in a starting material/ intermediate/ raw material where the control strategy  is in line with the principles and limits of the ICH M7 guideline.
• 删除/放宽起始物料/中间体/原料中诱变杂质的限度，使控制策略与ICH M7指南中的原则和限度保持一致
  

Note for renewal applications: the EDQM does not require the applicants to provide an updated discussion regarding control of mutagenic impurities following implementation of ICH M7 as part of the renewal documentation; however the applicant may wish to use the renewal procedure to update their control strategy as described above.

更新申报注意事项：EDQM不要求申报者提供根据ICH M7而更新的诱变杂质控制策略作为更新文件的一部分，但申报者可能希望使用更新程序按上述说明来更新其控制策略。

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720168772649235/