Key updates include:

Reporting Requirements: Following confirmatory testing, Market Authorization Holders (MAHs) must assess whether nitrosamine impurities exceed the established Acceptable Intake (AI) limit and determine whether market action is required. MAHs are no longer required to notify Health Canada each time an elevated nitrosamine impurity level is detected. Notification is only required when a recall decision has been made, in accordance with the Drug, Natural Health Product and Biocide Recall guide (GUI-0039).

Risk Mitigation Expectations: While the guidance maintains a 3-year CAPA implementation timeline, Health Canada expects MAHs to implement risk mitigation measures and reduce nitrosamine levels below AI limits as soon as possible.

Safety: New contact information has been added for enquiries regarding applicable Acceptable Intake (AI) limits, including proposal for new AI limits.

Appendix 2: The decision tree has been updated to reflect the revised expectations for filing nitrosamine risk mitigation-related changes. 

If you wish to understand how these changes might affect your business, please reach out to us.

The post Health Canada updates guidance on nitrosamine impurities in medications appeared first on Focal Point.

The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)

The post FDA Announces Fiscal Year 2026 OMOR Fee Rates: Costs to Increase appeared first on Focal Point.

This proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

The post 📢 FDA Modernization in Action: The Bemotrizinol Proposal & The Future of OTC Monograph Reform appeared first on Focal Point.

The agreement was made to reinforce the economic ties between the United States, Mexico, and Canada while replacing the North American Trade Agreement. The agreement promoted efficient and transparent customs procedures that reduce costs for both importers and exporters. The agreement includes regulations with elements of environmental protection and a gender bias analysis, which ensures equal opportunity for all gender, race, and for small and medium enterprises.  

We have previously reported on which products will be impacted by USMCA, however this list has since been amended. Previously, the impacted Natural Health Products and Non-Prescription Drugs were only those on Health Canada monographs. This has since been changed to include all products listed within the appendix of the USMCA, such as antiseptic skin cleansers, acne therapy products, and antiperspirants. This requires changes to List A: List of Certain Natural Health Products for Distribution as Samples, List D: List of Certain Non-prescription Drugs for Distribution as Samples, List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019, and of the Food and Drug Regulations Do Not Apply, to include all currently authorized products in the USMCA.  

This revision could not be made officially prior to the July 1^st implementation date. For now, the products listed in the appendix of the USMCA will be exempt from sampling prohibitions and the enforcement actions will be de-prioritized. After a comment period, a Notice of Modification as well as the revised lists will be published on Health Canada’s website.  

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. 

The post Implementation and Updates to the USMCA appeared first on Focal Point.

Distribution of NHP and Non-Prescription Drug Products as free samples was previously not permitted for those other than physicians, dentists, veterinarian surgeons, and pharmacists, according to Section 14 of the Food and Drug Act. Free samples of these types of products will soon be available to consumers and practitioners as well. Natural health products are those such as toothpastes. Such non-prescription drug products include mouthwashes, sunscreens, and medicated skin care products. A full list of the products under these new regulations are listed on List A: List of Certain Natural Health Products for Distribution as Samples (List A) of the Natural Health Products Regulations (NHPR) and List D: List of Certain Non-prescription Drugs for Distribution as Samples. These new regulations will not be applicable to drugs for veterinary use. Health Canada has also released a guidance document in order to assist.

The new regulations are to ensure safety, efficacy, quality standards, and restriction/conditions are met to ensure safety of products continues with distribution of samples. 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.

The post Health Canada: Changing Up the Sample Game appeared first on Focal Point.

The REP information will be sent to the HPFB via the Common Electronic Submissions Gateway (CESG) – similar to FDA drug submissions. XML format will be used and is ideal for Health Canada as it will minimize errors and therefore will improve consistency and reliability of the information captured. This new approach also eliminates the need for media such as CDs and DVDs. The template for the REP will aid in easier and faster data entry with drop down lists and predictive text.

Through the REP template, HPFB will collect routing IDs that will be used for two-way secure communication which will allow for quicker communication. The steps to beginning this process can be found here. As well, information on obtaining a dossier ID or obtaining a dossier from non-eCTD to eCTD is available here. It should be noted that the dossier is considered the REP dossier upon receipt of first transaction including a REP Regulatory Transaction XML file, afterwards the REP dossier must be provided using the REP company template. Health Canada recommends the familiarization of the Guidance Document: The Regulatory Enrolment Process for Drugs for Human Use and beginning the process of registering and setting up a CESG account and obtaining a dossier identifier as soon as possible, as this may take some time.

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

Emily Campbell

The post Health Canada: Mandatory Use of New Regulatory Enrolment Process for Drug Submissions appeared first on Focal Point.

Products impacted by this (Annex A of the bulletin) will no longer require identity testing after receipt in Canada and will also not be required to undergo confirmatory testing in the interim during this pandemic. Importers, however, will still be responsible for ensuring products meet their required specifications and were manufactured under Good Manufacturing Practices. This will give importers of products impacted by this the opportunity to directly ship from fabricators to retailers, as long as the importers release the product before being shipped via review of the necessary documentation and test results as well as ensuring quality agreements are put in place between the foreign manufacturer, importer, and receiver of product.

It should be noted that this update to current low risk non-prescription drug import regulations does not exempt the responsibility of Canadian Quality Control department to ensure all products comply with Canadian regulations. These updates simply minimize any delays that may occur in the process of importing non-prescription drugs during these troubling times.

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

Emily Campbell

The post Less Testing for Imported Low-Risk OTC Drugs – Temporarily appeared first on Focal Point.