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

Deadline Extended To Enable Companies To Perform A Thorough Investigation

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

EU regulators are giving drug companies more time to initiate manufacturing-related changes to their approved products in which higher than accepted levels of nitrosamine, or a new nitrosamine, have been detected.

The deadline for sponsors of chemical medicines to submit nitrosamine-related variations has been extended from 26 September 2022 to 1...

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