ICH M7“評(píng)估和控制藥物中DNA反應(yīng)性（致突變）雜質(zhì)以限制潛在致癌風(fēng)險(xiǎn)”是一個(gè)關(guān)于藥物致突變雜質(zhì)的指導(dǎo)原則，旨在為致突變雜質(zhì)的鑒定、分類(lèi)、定性和控制提供一個(gè)可行的框架方案，以控制其潛在的致癌風(fēng)險(xiǎn)。自ICH M7發(fā)布以來(lái)，關(guān)于DNA反應(yīng)性（致突變）雜質(zhì)的指導(dǎo)原則已在全球范圍內(nèi)獲得了大量的實(shí)踐經(jīng)驗(yàn)，同時(shí)也提出了對(duì)該類(lèi)雜質(zhì)的評(píng)估和控制做進(jìn)一步明確闡述的需求。ICH于2022年5月發(fā)布了ICH M7（R2）問(wèn)答，該文件旨在為ICH M7提供進(jìn)一步的明確和解釋?zhuān)?duì)以下2個(gè)方面促進(jìn)和提高一致性和協(xié)調(diào)性：評(píng)估和控制DNA反應(yīng)性（致突變）雜質(zhì)的考慮，藥品開(kāi)發(fā)、上市許可申請(qǐng)和/或藥品主文件中應(yīng)提供的信息。介紹ICH M7（R2）問(wèn)答文件的起草背景，對(duì)其進(jìn)行分析和解讀，并闡述非臨床審評(píng)關(guān)注點(diǎn)，以促進(jìn)業(yè)界對(duì)該文件的理解和運(yùn)用，以控制雜質(zhì)的潛在致癌性風(fēng)險(xiǎn)。

ICH M7 "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" is a guideline for mutagenic impurities in pharmaceuticals. The purpose of this guideline is to provide a practical framework that is applicable to the identification, categorization, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk. Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities. ICH M7(R2) Questions and Answers (Q&As) was approved by ICH on May 2022, and the Q&As document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorization applications and/or Master Files submissions. This article mainly introduces the drafting background and process of ICH M7 (R2) Q&As document, and also introduces and interprets the main content of the document, proposes some points to consider for and the non-clinical reviews, in order to promote the understanding and application of this document, and to limit potential carcinogenic risk of impurities.

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