EU Nitrosamines Oversight Group Sets Priorities
After agreeing on an EU-wide harmonized approach to deal with nitrosamine contamination in medicines, a recently formed regulatory oversight group has identified several topics requiring further scientific discussion.
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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.
EMA has set out four conditions which marketing authorization holders must meet before the suspension of ranitidine across Europe can be lifted.