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.
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FDA officials say that process and supply chain risks are some of the root causes driving many of the nitrosamine contamination problems in recent months and manufacturers should work to contain and control these risks.
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.