Europe Stands Firm On Nitrosamine Assessment Deadline For APIs

Companies Can Suggest New Timeline In Justified Cases

 
• By Vibha Sharma

The European Directorate for the Quality of Medicines & HealthCare says it will not extend the deadline for nitrosamine-related risk assessment of active substances even though an extension is in place for assessments of finished products.

woman in a laboratory microscope with microscope slide in hand.toned image.
Nitrosamine impurities have been found in marketed medicines in the recent past • Source: Shutterstock

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