Health Canada updates guidance on Adverse Reaction Reporting

Srishti Chaudhari — Thu, 02 Apr 2026 20:24:09 +0000

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 the Reporting Adverse Reactions to Marketed Health products – Guidance Document for Industry (2018) and the 2020 Notice to Industry.

The update aims to reduce duplicate reporting and regulatory burden. Under the revised guidance, MAHs are not required to routinely monitor the Canada Vigilance Online database or Health Product InfoWatch for Individual Case Safety Report (ICSR) obligations. However, MAHs must still report serious, unexpected adverse reactions occurring outside Canada, including those identified through foreign regulatory authority databases. If it cannot be confirmed whether the product belongs to the MAH, the report should be submitted to Health Canada with that limitation noted.

The updated guidance took effect on February 19, 2026. If you have questions or would like guidance on how this change may impact your processes, please reach out to our team.

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FDA Launches Public Dashboard for Real-Time Cosmetic Adverse Event Data

Sagarika Sharma — Tue, 28 Oct 2025 17:38:44 +0000

In a significant move towards increased transparency under the Modernization of Cosmetics Regulation Act (MoCRA), the U.S. Food and Drug Administration (FDA) has launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products.

This new, user-friendly dashboard is an interactive tool that allows the public, industry, and researchers to query and download real-time data on adverse events related to cosmetic products. According to the FDA, the reports are updated daily to include the most recent submissions.

The dashboard contains data from two key sources:

Mandatory Reports: Serious adverse event reports submitted by cosmetic companies (“responsible persons”) as required by MoCRA.
Voluntary Reports: Reports submitted to the FDA by consumers, healthcare professionals, and others.

Impact on the Industry:

This public-facing tool marks a new era of transparency for cosmetic product safety. It provides a direct view into the safety data being collected by the agency and will be a critical resource for post-market surveillance. Companies can monitor trends related to their own products, ingredients, and entire product categories.

We encourage all industry professionals, particularly those in regulatory, quality, and safety roles, to explore this new dashboard to understand its capabilities and implications for your business.

Please contact us if you require assistance with your adverse event reporting procedures or overall MoCRA compliance strategy.

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Adverse Event Data Archives - Focal Point

Health Canada updates guidance on Adverse Reaction Reporting

FDA Launches Public Dashboard for Real-Time Cosmetic Adverse Event Data