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At the time of writing this commentary, the ICH M7 Q&A (version 29 June 2020) has been signed off as a Step 2 document and released for public consultation. (https://www.ich.org/page/multidisciplinary‐guidelines).

The ICH M7 guideline was adopted by ICH in June 2014, and the first addendum (R1) was adopted in May 2017. The Q&A document was developed to provide additional clarification to details having led to differing interpretation by stakeholders, such as justification of control strategy in marketing authorization applications, organization and detail of information on mutagenic impurities in marketing authorization applications, and clarification with regard to (Q)SAR systems. Ultimately, the intention of the Q&A document was to promote further harmonization in using this guidance in regulation of mutagenic impurities in pharmaceuticals.

During the process of preparation of the Q&A document, stakeholders submitted more than 100 questions to the reference as ICH M7 expert reference group. The EWG consolidated related questions, and finally 25 Q&As were included in the Step 2 document. The Q&A document is structured according to the sections in the original guideline.

This commentary will present the relevant section within the original guideline and then discuss the respective Q&As on that section. Some queries will be put forth showing that not all controversial issues have been clarified, and we can only hope that the further steps of this Q&A document will be modified to clarify these contentious topics.