More Time For EU Nitrosamine Evaluations Due To COVID-19
Companies Are Allowed Additional Six Months
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.
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Two groups have issued largely complementary testing methods for measuring nitrosamine impurities in drugs, and the differences that do exist are “insignificant,” EDQM official advises. The two are working to further harmonize testing standards, given the global scope of the nitrosamine scare.
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.
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.