Serious Adverse Event Reporting Archives - Focal Point https://focalpointresearch.net/tag/serious-adverse-event-reporting/ Scientific, Regulatory and New Product Consultants Thu, 02 Apr 2026 20:24:34 +0000 en-US hourly 1 https://wordpress.org/?v=7.0.4 https://focalpointresearch.net/wp-content/uploads/2021/11/cropped-focal_point_chart_03-32x32.jpg Serious Adverse Event Reporting Archives - Focal Point https://focalpointresearch.net/tag/serious-adverse-event-reporting/ 32 32 126679100 Health Canada updates guidance on Adverse Reaction Reporting https://focalpointresearch.net/uncategorized/health-canada-updates-guidance-on-adverse-reaction-reporting/ Thu, 02 Apr 2026 20:24:09 +0000 https://focalpointresearch.net/?p=5812 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 […]

The post Health Canada updates guidance on Adverse Reaction Reporting appeared first on Focal Point.

]]> 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.

The post Health Canada updates guidance on Adverse Reaction Reporting appeared first on Focal Point.

]]> 5812