Nitrosamine impurities document updated to reflect new risk assessment process for human pharmaceutical products 

Drug Establishment Licensing Bulletin 87, June 12, 2020

Health Canada is working on reducing the risk of nitrosamine contamination for all active pharmaceutical ingredients (APIs) and drug products. To this end, Health Canada issued a letter on October 2, 2019, to market authorization holders (MAHs). We asked MAHs to follow a 3-step process for conducting risk assessments of their drug products containing chemically synthesized APIs.

We updated the nitrosamines questions-and-answers guidance document on June 12, 2020, to reflect this process.

You can ask for a copy of the latest version by emailing us at bpsenquiries@hc-sc.gc.ca.