Nitrosamine update on pharmaceutical, biological and radiopharmaceutical products

Drug Establishment Licensing Bulletin 103, December 15, 2020

Health Canada continues to work with companies and our international regulatory partners to:

• determine the root causes of the issue of nitrosamine impurities
• verify that appropriate actions are taken to minimize or avoid the presence of nitrosamine impurities

We notified market authorization holders (MAHs) of human pharmaceutical products on October 2, 2019. We asked that they evaluate in detail their manufacturing procedures and controls for the potential presence of nitrosamines.

On December 15, 2020, we expanded the scope of nitrosamine evaluations to companies marketing biological and radiopharmaceutical products. We sent a letter to these companies outlining our expectations. This expanded scope does not apply to MAHs of antimicrobial agents, veterinary health products and natural health products.

If you have questions about this letter, please email us at hc.brdd.ora.sc@hc-sc.gc.ca.

Also on this date, we updated the nitrosamines questions-and-answers guidance document to reflect the changes outlined in our October 2, 2019, letter about nitrosamine impurities. This document also gives guidance to MAHs of biological and radiopharmaceutical products.

We will continue to update this guidance document as new information becomes available.

For a copy of the latest version, please email us at bpsenquiries@hc-sc.gc.ca.