Europe Stands Firm On Nitrosamine Assessment Deadline For APIs
Companies Can Suggest New Timeline In Justified Cases
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.
You may also be interested in...
After EU regulators decided that biological medicines should be reviewed for the presence of possible nitrosamine impurities – as is already required for chemical medicines – new deadlines have been agreed on to give companies enough time to comply.
Although biological medicines carry a very low risk of being contaminated by nitrosamine impurities, the EMA says the possibility cannot be ruled out.
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.