ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
HumanQuality of medicinesScientific guidelines
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
AdoptedReference Number: EMA/CHMP/ICH/83812/2013
English (EN) (1 MB - PDF)
First published:
ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Step 5
AdoptedReference Number: EMA/CHMP/ICH/502766/2021
English (EN) (1.95 MB - PDF)
First published:
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
English (EN) (695.59 KB - PDF)
First published:
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
English (EN) (185.79 KB - PDF)
First published: Last updated:
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 closedConsultation dates:
to Reference Number: EMA/CHMP/ICH/502766/2021
English (EN) (989.54 KB - PDF)
First published:
ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5
AdoptedReference Number: EMA/CHMP/ICH/83812/2013
English (EN) (1.34 MB - PDF)
First published: Last updated:
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
English (EN) (231.48 KB - PDF)
First published:
Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 4
AdoptedReference Number: EMA/CHMP/ICH/83812/2013Summary:
This document is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
English (EN) (476.61 KB - PDF)
First published: Last updated:
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 closedConsultation dates:
to Reference Number: EMA/CHMP/ICH/458894/2015
English (EN) (949 KB - PDF)
First published: Last updated:
Questions and answers on the guideline on the limits of genotoxic impurities
AdoptedReference Number: EMEA/CHMP/SWP/431994/2007 Rev. 3
English (EN) (366.64 KB - PDF)
First published: Last updated:
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 closedConsultation dates:
to Reference Number: EMA/CHMP/ICH/321999/2020Summary:
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 [email protected].
English (EN) (403.88 KB - PDF)
First published:
Superseded documents
Guideline on the limits of genotoxic impurities
AdoptedReference Number: EMEA/CHMP/QWP/251344/2006 Legal effective date:
English (EN) (445.06 KB - PDF)
First published: Last updated:
ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5
AdoptedReference Number: EMA/CHMP/ICH/83812/2013
English (EN) (1.34 MB - PDF)
First published: Last updated:
External links
ICH M7 (R1) Video Training Material (see M7 (R1) Video Training Material under Relevant sections of M7 Mutagenic impurities: WG Presentations / Trainings
ICH M7(R2) Step 2 Presentation (see ICH M7(R2) Step 2 Presentation under Relevant sections of M7 Mutagenic impurities: WG Presentations / Trainings)
ICH M7 (R2) Questions and Answers: Step 2 Presentation (see ICH M7 (R2) Questions and Answers: Step 2 Presentation under Relevant sections of M7 Mutagenic impurities: WG Presentations / Trainings)