ICH M7 Mutagenic Impurities Implementation Dates

ICH M7 Human Medicinal Products

January 2016

First version: ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk – Step 4 EMA/CHMP/ICH/83812/2013

Final adoption by CHMP: July 2014

Date for coming into effect: January 2016

February 2018

Current effective version: ICH M7 (R1) Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks – Step 5 EMA/CHMP/ICH/83812/2013

Final adoption by CHMP: February 2018

Date for coming into effect: February 2018

July 2020

Question and answers on ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks EMA/CHMP/ICH/321999/2020

October 2020

Overview of comments received on ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks – Questions and Answers EMA/538158/2020

Pending

Draft version of ICH M7 Addendum: ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks – Addendum – Step 2b EMA/CHMP/ICH/272147/2021

Consultation closed: 8 December 2021

Overview of comments received on ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks – Addendum – Step 2b EMA/743397/2021

Published: 14 December 2021

Veterinary Medicinal Products

December 2018

Overview of comments received on Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Veterinary Medicinal Products EMA/CVMP/SWP/610519/2017

July 2020

Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Veterinary Medicinal Products EMA/CVMP/SWP/377245/2016

Adoption by CVMP: 6 December 2018

Date for coming into effect: 1 July 2020

You can check Tox by Design methodology for Mutagenic impurities Risk assessment, which are duly validated and signed by an European Registered Toxicologist expert.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that Tox by Design is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using the Quotation Request below to receive a quotation for Risk assessment of such Mutagenic impurities present in your drug substances and products.