Companies Get Yet More Time To Assess Nitrosamine Risk In EU

Deadline For Assessing Chemical Medicines Extended Until 31 March 2021

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...

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