EU Regulators Take A Practical Approach To Addressing Nitrosamine Contamination
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.
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After agreeing on an EU-wide harmonized approach to deal with nitrosamine contamination in medicines, a newly-created regulatory oversight group has identified several topics requiring further scientific discussion.
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.
Although biological medicines carry a very low risk of being contaminated by nitrosamine impurities, the EMA says the possibility cannot be ruled out.