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Companies Get Yet More Time To Assess Nitrosamine Risk In EU

Deadline For Assessing Chemical Medicines Extended Until 31 March 2021

 
• By Vibha Sharma

After EU regulators decided that biological medicines should be reviewed for the presence of possible nitrosamine impurities – as is already required for chemical medicines – new deadlines have been agreed on to give companies enough time to comply.

Nitrosodimethylamine
Nitrosamines are classified as probable human carcinogens • Source: Shutterstock

EU regulators are giving yet more time to sponsors of medicines containing chemically synthesized active pharmaceutical ingredients to assess their products for the possible presence of cancer-causing nitrosamine impurities. They have also set a new deadline for sponsors of biological medicines to carry out similar assessments.

The deadline for conducting nitrosamine-related risk assessments of chemical medicines has now been extended until 31 March 2021, replacing the previous deadline of 1 October 2020. For biological medicines, these...

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