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EU Regulators Take A Practical Approach To Addressing Nitrosamine Contamination

 
• By Vibha Sharma

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.

Medic staff at work in the laboratory. Background
Chemical and biological drug sponsors must review their products for possible presence of nitrosamines • Source: Shutterstock

As the EU deadline draws near for drug sponsors to finish reviewing their medicines for the presence of cancer-causing N-nitrosamines impurities, the European medicines regulatory network has agreed on practical steps it intends to take if impurities are detected in marketed drugs.

The arrangements are listed in a plan published on 22 February. It outlines specific measures that EU regulators intend to...

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