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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