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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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.
A much slimmed-down August agenda for the European Medicines Agency’s drug assessment body, the CHMP, also shows that Janssen has asked for more time to reply to questions about its potential multiple sclerosis therapy, ponesimod.
Although biological medicines carry a very low risk of being contaminated by nitrosamine impurities, the EMA says the possibility cannot be ruled out.