Press release by ICH on the Fukuoka meeting.
The Assembly adopted a new topic for harmonisation at the Fukuoka meeting:
- An Addendum to the Multidisciplinary Guideline M7 on “Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” to address safety assessment and establishment of appropriate controls for nitrosamine impurities through a staged approach, leveraging the Formal ICH Procedure, as well as to develop a harmonised set of acceptable intakes (AIs) leveraging the M7 Maintenance Procedure.
https://www.ich.org/pressrelease/press-release-ich-assembly-meeting-fukuoka-japan-june-2024