Search
Close this search box.
Logo Asphalion

ICH M7 Guideline | Assessment and Control of DNA reactive impurities in pharmaceuticals

August 30, 2023

The European Medicines Agency Committee for Medicinal Products for Human Use published recently a new Question and Answer document, following the publication of Revision 2 of ICH M7 and its addendum on the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, with the aim to clarify and address Quality and Safety issues that have been identified from experience through implementation of M7 since its publication in 2014. Clarification on the justification of control strategy for mutagenic impurities in the marketing authorization dossier, organization and depth of information reporting of individual mutagenic impurities, (Q)SAR systems, and other safety-related information are provided.

You can have a look at the complete Q&As document here: ICH M7 Q&As

ICH M7(R2) and its Addendum will come into effect on September 30, 2023.

From Asphalion, we can offer you all kinds of support on drug development, marketing authorization applications and/or Master Files submissions.

In case you have any doubts, you can contact us for further information: info@asphalion.com

Alternatively, you can schedule a free 30-minutes meeting with our experts: https://bit.ly/3NwVsNR

We´ll be happy to assist you!

Search News & Events

  • Filter by category

Share

Related news and events

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting