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EMA releases guidance to companies on avoiding nitrosamines in drugs

The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.

EMA drug guidance

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has released its guidance for companies on avoiding the presence of nitrosamines in drugs.

The EMA… will continue to work closely with national authorities and international partners”

Nitrosamines are classified as probable human carcinogens and the CHMP has announced it will continue to evaluate the presence of nitrosamines in medicines.

The CHMP has also requested that marketing authorisation holders for medications containing chemically synthesised active substances review their drugs for the presence of the impurities. If nitrosamines are detected, marketing authorisation holders must inform authorities promptly.

Industry guidance

The steps that companies should take are as follows:

  • Evaluate possibility of nitrosamines being present in every concerned medicine within six months
  • Prioritise evaluations, starting with medicines more likely to be at risk of containing nitrosamines
  • Take into account findings from CHMP’s review of sartans
  • Notify authorities of outcome of risk evaluations
  • Test products at risk of containing any nitrosamines
  • Immediately report detection of nitrosamines to authorities
  • Apply for necessary changes to marketing authorisations to address nitrosamine risk
  • Complete all steps within three years, prioritising high risk products.

The EMA has said that it will continue to work closely with national authorities and international partners to ensure the quality of medicines within Europe.

Guidance for marketing authorisation holders can be found here.  

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