EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders (MAHs) for human medicines containing chemically synthesized 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, MAHs must inform authorities promptly so that appropriate regulatory actions can be taken.
MAHs are responsible for ensuring that every batch of their finished product is of satisfactory quality, including the active principle ingredients (API) and other ingredients used to manufacture them.
Human medicinal products containing sartans with a tetrazole ring were included in the Article 31 review of the Commission and MAHs of these products must implement the recommendations from this review as set out in the respective Commission Decisions earlier this year.
For human medicinal products containing APIs other than sartans with a tetrazole ring, MAHs must perform the following steps:
- Evaluate the possibility of nitrosamines being present in their medicinal products containing chemically synthesized API. This risk evaluation must be concluded at the latest by 19 March 2020 and evaluations should be prioritized, starting with medicines more likely to be at risk of containing nitrosamines
- Notify authorities when the risk evaluation is concluded, making the risk evaluation documents available upon request.
- Test products at risk of containing any nitrosamines (confirmatory testing)
- Immediately report any detection of nitrosamines to authorities
- Apply for a variation to introduce any necessary changes to marketing authorizations to address nitrosamine risk
- Complete all steps within 3 years (19 September 2022)
A notice and questions-and-answers document is available on the EMA’s website.