Although the ICH Q3A and Q3B guidelines establish reporting and qualification thresholds, there was a regulatory gap when new impurities appeared or their levels increased after marketing authorization. This document provides updated criteria and promotes more scientific and proportionate approaches.
Marketing Authorization Holders managing post-approval changes
Sponsors developing new medicinal products
Quality, CMC, and toxicology teams involved in impurity control strategies
We support companies in aligning impurity qualification programs with the new EMA framework through:
If you are managing post-authorization changes or emerging impurities in development, early alignment with this framework will be critical.