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.