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.
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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.