by Srishti Chaudhari | Apr 2, 2026 | Canadian Quality Assurance, Canadian Regulatory, Health Canada Updates, Natural Health Products, Uncategorized
Health Canada has issued a notice clarifying adverse reaction reporting expectations for Market Authorization Holders (MAHs) of drugs (including pharmaceuticals, biologics and radiopharmaceuticals) and Natural Health Products (NHPs). The notice replaces Section 4.3 of...
by Srishti Chaudhari | Apr 2, 2026 | Canadian Regulatory, Health Canada Updates, Medical Device, Medical Devices
Health Canada has introduced several key regulatory updates in 2026 that significantly change how medical device applications are prepared and submitted. A major update is the new Guidance on Managing Applications for Medical Device Licenses (effective February 2,...
by Sagarika Sharma | Apr 2, 2026 | Cosmetics, Health Canada Updates, Our View
On March 25, 2026, the Government of Canada published Order 2026-87-20-01 in the Canada Gazette, Part II. This order introduces significant amendments to the Domestic Substance List (DSL) under the Canadian Environmental Protection Act (CEPA). The changes impact...
by Sagarika Sharma | Dec 4, 2025 | Canadian Quality Assurance, Canadian Regulatory, Cosmetic Ingredient Hotlist, Cosmetics, Health Canada Updates, Our View
Health Canada has launched a consultation on proposed updates to the Cosmetic Ingredient Hotlist. These changes are intended to enhance consumer safety by restricting or prohibiting certain ingredients based on new safety data. Proposed Additions (New...
by Srishti Chaudhari | Nov 3, 2025 | Canadian Regulatory, Health Canada Updates, Importation of NHPs, Natural Health Products, Our View
Health Canada, under Bulletin No. 8, has provided updates to help streamline the site licence amendment and notification process for NHPs, improving predictability and speeding up license decisions. Key updates: Separate submissions: Amendment applications must be...
by Sagarika Sharma | Nov 3, 2025 | Health Canada Updates, Importation of NHPs, Natural Health Products, OTC Drugs
Health Canada has launched a 60-day public consultation on its revised “Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products.” The consultation period opened on October 24, 2025, and will close on December 23, 2025....
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