As outlined on their website here, Health Canada is asking the following from Market Authorization Holders:

· To review their products and manufacturing processes for the possible presence of nitrosamines

· To take any necessary measures to ensure that their products do not contain nitrosamines at levels exceeding the accepted limit

· To test products if a risk of nitrosamines is identified

· To immediately report to Health Canada if nitrosamines are detected

More specifically, it is now recommended that all Market Authorization Holders “work with API and drug manufacturers to review their API and drug product manufacturing processes [and] conduct risk assessments, taking into account their knowledge of the manufacturing processes, potential sources of contamination and any other root causes of formation and presence of nitrosamine impurities”. As outlined in their question and answer document, Health Canada has stated that when a nitrosamine impurity is detected at any level during a risk assessment, you are to inform them immediately, as well as submit any available details of the risk assessment to them. In all other circumstances, risk assessment documentation should be retained by the Market Authorization Holder. However, it should be noted that Health Canada can request to review the MAH’s risk assessment report for any product and will request this information directly from the MAH, as necessary.

At the time, this information pertains only to “human pharmaceutical products containing chemically synthesized active pharmaceutical ingredients (APIs), including prescription and non-prescription (over the counter) drug products” as well as “chemically synthesized excipients and raw materials used in the manufacturing of drug products, and drug products that have been approved but are not yet marketed”. Therefore, products that fall under the classification of cosmetics or natural health products are not affected by these changes at this time.

Health Canada has stated that “Nitrosamines are not expected to cause harm when ingested at low levels. For example, a person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer. As the health risk is associated with long-term use of a contaminated drug, Health Canada continues to underscore that people who take prescription sartan, ranitidine and nizatidine drugs affected by this issue, including recalled ranitidine and sartan drugs, should continue taking their medication until they have obtained an alternative treatment from their health care provider. Not treating a condition may pose a greater health risk than

potential nitrosamine exposure.” If you are a patient concerned about these new changes or that your medication may be affected by these updates, Health Canada advises you to contact your health care provider for more information.

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

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The Canadian Environmental Protection Act, 1999 (CEPA, 1999) was implemented by Health Canada to protect the environment and human health by contributing towards sustainable development. A section of the Act focuses on decreasing the risks associated with new and existing substances. Substance lists were established to distinguish new substances from existing ones, and to determine reporting requirements or risk assessments needed for certain substances.

The In-Commerce List is an administrative list created for substances regulated under the Food and Drugs Act (FDA) that had been subject to the New Substances Notification Regulations (NSNR) and CEPA 1999 in September 2001. The Revised In-Commerce List (R-ICL) was created to address necessary concerns of substance duplications, omissions, and inaccuracies that were on the In-Commerce List.

Recent News Updates:

One year following a final notice published in the Canada Gazette Part I in November 2018, nomination of substances to the Revised In-Commerce List will close on November 3^rd, 2019. Of the substances that are regulated under the Food and Drugs Act, substances that are no longer in commerce will likely be removed from the R-ICL in future updates.

The following 20 pharmaceutical ingredients were under review in 2017-2018 as higher priority substances with potential risk to human health: Alendronate sodium and Alendronic acid; Modafinil; Divalproex sodium; Gliclazide; Gabapentin; Lamotrigine; Sucralfate; Celecoxib; Ephedrine, Ephedrine dl-, and Ephedrine sulfate; Entacapone; Atomoxetine hydrochloride; Atovaquinone; Bupropion hydrochloride; Cefazolin sodium; Oxcarbazepine; Acebutolol hydrochloride; Domperidone, Domperidone maleate; Lopinavir; Telmisartan; Olanzapine.

The assessment reports for these 20 ingredients are scheduled to be published in 2020/2021. Post 2020, HC aims to retire the R-ICL list by publishing rapid screening documents for low-priority/low volume substances and bringing feasible substances into compliance with CEPA regulations to be incorporated into the Domestic Substances List (DSL). Non-response to Section 71 substances will result in removal from the R-ICL.

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.

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