Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators
Industry's Request For A Standardized Approach Has Been Set Aside
EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.
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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.
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.