M7(R3) – Maintenance of the Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities

The ICH M7 Guideline was finalised under Step 4 in June 2014, with a M7(R2) Guideline and Addendum reaching Step 4 of the ICH process in April 2023 and M7(R2) Q&A reaching Step 4 in May 2022.

Maintenance Process
A Maintenance process for the M7 Guideline was set up to enable the revision and inclusion of new drug substances and drug products and the assessment of the mutagenic potential of impurities.

Harmonised

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

In Process

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Pre-harmonisation

M7(R3) – Maintenance of the Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities

Ongoing public consultations

M7(R3) Maintenance Expert/Implementation Working Group

Rapporteur

Regulatory Chair

Experts

Rapporteur Supporter

Alternate

Related guidelines

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk