EU Allows Firms More Time To Make Nitrosamine-Related Manufacturing Changes

Deadline Extended To Enable Companies To Perform A Thorough Investigation

 
• By Vibha Sharma

The European medicines regulatory network is giving sponsors of marketed medicines that contain chemically synthesised active substances an extra 12 months to apply for manufacturing changes to address nitrosamine-related risks.

woman in a laboratory microscope with microscope slide in hand.toned image.
Nitrosamine impurities have been found in marketed medicines in the recent past • Source: Shutterstock

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