New timelines for human pharmaceutical products containing nitrosamines

Drug Establishment Licensing Bulletin 79, March 27, 2020

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

Many MAHs are facing significant challenges in completing the nitrosamine impurities risk assessments and subsequent actions within the original timeframe. This is due to the global COVID-19 outbreak.

For this reason, we are extending the deadlines for conducting risk assessments and subsequent actions as follows.

• Step 1, risk assessments:
  • by October 1, 2020
• Step 2, confirmatory testing:
  • by October 1, 2022
• Step 3, changes to the market authorization (as required):
  • by October 1, 2022

If you have questions about the October 2, 2019, letter or this bulletin, please email us at bpsenquiries@hc-sc.gc.ca.