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EU Nitrosamines Oversight Group Identifies Priority Topics

 
• By Vibha Sharma

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.

man holding capsules in front of complete wavy national flag of europe symbolizing health, medicine, cure, vitamines and healthy life
EU regulators have detected nitrosamine impurities in certain well-established medicines • Source: Shutterstock

A newly established group of EU regulators that is focused on ensuring that drug companies follow a harmonized approach to addressing any nitrosamine contamination in their products has identified several priority topics that it plans to tackle within a specified timeframe.

The Nitrosamine Implementation Oversight Group (NIOG) comprises representatives from the European Medicines Agency, the Coordination Group for EU Mutual Recognition and Decentralised Procedures - Humans (CMDh) and the European Directorate...

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