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
First revision: 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
Questions 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
July 2023
Second revision: ICH M7 (R2) 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: 30 March 2022
Date for coming into effect: 30 September 2023
ICH M7 (R2) Addendum on Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intake – Step 5 EMA/CHMP/ICH/502766/2021
Final adoption by CHMP: 30 March 2023
Date for coming into effect: 30 September 2023
Questions and answers on ICH M7 (R2) Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks EMA/CHMP/ICH/321999/2020
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.