ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline

This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use.

Keywords: Impurities, genotoxicity, mutagenic, carcinogenic

Current version - effective from 30/09/2023

ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5

Adopted Reference Number: EMA/CHMP/ICH/83812/2013

ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Step 5

Adopted Reference Number: EMA/CHMP/ICH/502766/2021

ICH M7(R2) Questions and Answers on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5

Reference Number: EMA/CHMP/ICH/321999/2020

Document history

Overview of comments received on 'Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b'

Reference Number: EMA/743397/2021

Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b

Draft: consultation closed Consultation dates: 08/10/2021 to 08/12/2021 Reference Number: EMA/CHMP/ICH/502766/2021

ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5

Adopted Reference Number: EMA/CHMP/ICH/83812/2013

Overview of comments received on ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers (EMA/CHMP/ICH/321999/2020)

Reference Number: EMA/538158/2020

Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 4

Adopted Reference Number: EMA/CHMP/ICH/83812/2013 Summary:

This document is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

ICH M7(R1) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Step 2b

Draft: consultation closed Consultation dates: 04/08/2015 to 03/02/2016 Reference Number: EMA/CHMP/ICH/458894/2015

Questions and answers on the guideline on the limits of genotoxic impurities

Adopted Reference Number: EMEA/CHMP/SWP/431994/2007 Rev. 3

Questions and answers - ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 2b

Draft: consultation closed Consultation dates: 03/07/2020 to 02/10/2020 Reference Number: EMA/CHMP/ICH/321999/2020 Summary:

This question and answer (Q&A) document aims to provide additional clarification and to promote convergence and harmonisation of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information provided during drug development, marketing authorisation applications and/or master files.

The scope of this Q&A document follows that of ICH M7.

Use the comments form to provide comments. The completed comments form should be sent to [e-mail].

Superseded documents

Guideline on the limits of genotoxic impurities

Adopted Reference Number: EMEA/CHMP/QWP/251344/2006 Legal effective date: 01/01/2007

ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5

Adopted Reference Number: EMA/CHMP/ICH/83812/2013