EU Nitrosamines Oversight Group Identifies Priority Topics
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.
You may also be interested in...
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.
Although biological medicines carry a very low risk of being contaminated by nitrosamine impurities, the EMA says the possibility cannot be ruled out.