Health Canada updates guidance on nitrosamine impurities in medications

Drug Establishment Licensing Bulletin 161, January 12, 2024

Health Canada has updated the Guidance on nitrosamine impurities in medications

Updates include a new timeline for completing changes to the market authorization (step 3 of the call for review) for:

• biological and radiopharmaceutical drug products
• drug products containing chemically synthesized and semi-synthetic active pharmaceutical ingredients

This new date is August 1, 2025.

Updates have also been made to general, safety (Appendix 2) and quality-related topics (including Appendix 1). Examples of changes include:

• additional recommendations for managing and submitting step 3 changes to the market authorization on risk mitigation measures (section 13)
• updates to the thresholds for reporting to Health Canada on the presence of nitrosamine impurities in drug products (numbers 3 and 15)
• established acceptable intakes (AI) for 3 additional nitrosamine impurities
• revisions to the AI limits for 2 nitrosamine impurities

Sections that have updated from the previous version are identified with the descriptor "updated".

If you have any questions or comments, please email us at bpsenquiries@hc-sc.gc.ca.