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Health Canada: Guidance on Nitrosamine Impurities in Medications

Health Canada last week published an updated "Guidance on Nitrosamine Impurities in Medications" that details about on Evaluating and managing the risks of N-nitrosamine impurities in human pharmaceutical, biological and radiopharmaceutical products.


In this guidance, Health Canada presents its current thoughts and recommendations regarding N-nitrosamine impurities (nitrosamine impurities or nitrosamines) and may alter it as new information becomes available or as more guidance is required for applicants or market authorization holders (MAHs).

Nitrosamine impurities are a type of chemical impurity that can be found in some pharmaceuticals and other products that contain the nitroso functional group (-NO), which is known to be a potential carcinogen.


Manufacturers are required to perform risk assessments and take appropriate measures to control the potential for nitrosamine formation, such as using alternative manufacturing processes, sourcing materials from different suppliers, and conducting additional testing.


Below are the Timelines for completing risk assessments (Step 1), confirmatory testing (Step 2), and changes to the market authorization (Step 3)

For drug products containing chemically synthesized and semi-synthetic APIs, the steps for actions relating to nitrosamines are expected to be completed as follows:

  • Step 1: risk assessments by March 31, 2021

  • Step 2: confirmatory testing by October 1, 2022

  • Step 3: changes to the market authorization by October 1, 2023

For biological and radiopharmaceutical products, the steps for actions relating to nitrosamines are expected to be completed as follows:

  • Step 1: risk assessments by November 30, 2021

  • Step 2: confirmatory testing by November 30, 2023

  • Step 3: changes to the market authorization by November 30, 2023

To know more in detail about Confirmatory testing, AI limits, and important questions & answers related to Nitrosamine Impurities, click this LINK.

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