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Why is it relevant?
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.
Main takeaways
Who is affected?
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Marketing Authorization Holders managing post-approval changes
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Sponsors developing new medicinal products
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Quality, CMC, and toxicology teams involved in impurity control strategies
What MAHs should do now
How we can support
We support companies in aligning impurity qualification programs with the new EMA framework through:
- Integrated risk assessments
- Regulatory justification packages
- Acceptable Level calculations and TTC application
- Read-across strategies and NAM implementation
If you are managing post-authorization changes or emerging impurities in development, early alignment with this framework will be critical.
