Health Canada Risk Evaluation of N-nitrosamine Impurities: First Step Deadline Fast Approaching

by | Mar 7, 2021 | Canadian Regulatory, OTC Drugs

The deadline for the first step of Health Canada’s new risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products is fast approaching. This new Health Canada requirement for all Market Authorization Holders (MAHs) of Canadian human pharmaceuticals, biologicals and radiopharmaceuticals drug products was originally announced in October 2019with the first step of the risk evaluation process due April 2, 2020 (product risk assessments). However, due to the COVID-19 global pandemic, the first deadline was originally postponed until October 1, 2020 on March 26, 2020. It was then further extended on August 10, 2020 to March 31, 2021 for all drug products containing chemically synthesized APIs. For MAHs of biological and radiopharmaceutical products, this was extended even further to November 30, 2021.

To provide a brief background on the topic, Health Canada published a notice on a requirement for all MAHs of Canadian drug products classified as human pharmaceuticals, biologics and radiopharmaceuticals to evaluate and analyze their products for any presence of N-nitrosamine impurities. This was due to the concern that N-nitrosamine impurities have on human health as they are classified as probable carcinogens. Health Canada has requested that MAHs thoroughly review their products and manufacturing process for any potential sources of N-nitrosamine impurities (step 1: risk assessments – to be retained by the MAH) including reaching out to their API suppliers for an evaluation on their APIs, test their products for any potential presence of N-nitrosamine impurities (step 2: confirmatory testing), make any necessary changes to the product to ensure their products do not exceed the acceptable limit of nitrosamines (step 3: changes to the market authorization as a result of the previous steps), and then report the presence of nitrosamines within their products to Health Canada, if applicable.

For MAHs of drug products containing chemically synthesized APIs, please note the following due dates for the risk evaluation steps:

  1. Risk Assessments: Due March 31, 2021
  2. Confirmatory Testing (If a risk is identified): Due October 1, 2022
  3. Changes to the market authorization: Due October 1, 2022

For MAHs of biological or radiopharmaceutical products, please note the following due dates for risk evaluation steps:

  1. Risk Assessments: Due November 30, 2021
  2. Confirmatory Testing (If a risk is identified): Due November 30, 2023
  3. Changes to the market authorization: Due November 30, 2023

Our most recent article on this matter can be found here. For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.