Earlier this year, information about new regulations and requirements put in place by Health Canada for product’s containing nitrosamine impurities was released. These regulations are applicable to prescription and non-prescription pharmaceuticals containing chemically synthesized Active Pharmaceutical Ingredients (APIs). It was noted that Market Authorization Holders (MAHs) are responsible for testing their products to determine the presence of nitrosamine impurities. It is up to the MAH to determine what their products should be tested for, such as max daily dosage, duration of use, and considerations of specific populations, such as children and pregnant women. If the outcome of the tests indicates the product is safe, the results should be retained by the MAH. If any impurities are detected during testing, the MAH is required to inform Health Canada immediately to allow proper steps to be taken.
In the original release of Health Canada’s letter, it was requested that the MAHs conduct these risk assessments for all their products within 6 months of the release of the letter to the public. This would have meant the MAHs had until April 2, 2020 to complete product risk assessments for all their synthesized Active Pharmaceutical Ingredients (APIs). The letter also requested that all confirmatory testing and any changes to the marketing authorizations be completed within two years, with a deadline of October 1, 2021. Now, as a result of the COVID-19 pandemic, Health Canada has provided an extension and has released an updated timeline. The risk assessments now must be completed by October 1, 2020 and confirmatory tests and any changes to the market authorization must be completed by October 1, 2022.
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