Companies Get Yet More Time To Assess Nitrosamine Risk In EU
Deadline For Assessing Chemical Medicines Extended Until 31 March 2021
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.
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Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.
Regulators in the EU have decided on specific arrangements they plan to employ if sponsors detect and report nitrosamine impurities in their products being sold on the market.
National regulators throughout the EU will ask manufacturers of rifampicin-containing medicines to check their products for nitrosamine impurities before they are released for sale.