Friday, 27 December 2019

EMA advises companies on steps to take to avoid nitrosamines in human medicines

EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities promptly so that appropriate regulatory actions can be taken.

A notice  to this effect is being sent out to marketing authorisation holders with information on the actions they should take. A questions-and-answers document is also available on EMA’s website.
Marketing authorisation holders are responsible for ensuring that every batch of their finished product is of satisfactory quality, including the active substances and other ingredients used to make them. They should take into account the published guidance along with knowledge of the manufacturing processes for their products and all other relevant scientific evidence.

Steps companies should take:

  • Evaluate possibility of nitrosamines being present in every concerned medicine within 6 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 3 years, prioritising high risk products


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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