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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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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Companies seeking approval of new drugs must provide information on nitrosamine-related risk evaluation either as part of their marketing application or during the evaluation process.