2025 - Proposed Updates to Health Canada’s Guidance on Summary Reports

Health Canada (HC) has released proposed updates to its “Guidance on preparing and submitting summary reports for marketed drugs and natural health products” and the related “Draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product.” These documents were released for public consultation on October 24, 2025 and will replace the 2018 edition once finalized. This webinar will cover the proposed revisions and examine the key changes to the summary reporting requirements for the Market Authorization Holders (MAHs) and license holders.
The modifications integrate existing guidance materials on summary reporting, clarify expectations, simplify language, address stakeholder inquiries and issues, polish explanations and methods and revise filing procedures. To improve transparency, guidance on summary reporting for drugs and for natural health products has been divided to more effectively tackle the unique regulatory and practical factors for these product categories. Besides offering direction to MAHs under the Food and Drug Regulations (FDR) and to license holders under the Natural Health Products Regulations (NHPR) on how to comply with the summary reports guidance standards, the documents provide instructions to HC personnel on how the rules are implemented in an equitable, uniform and efficient manner throughout Canada.
The featured speakers will examine the effects of the proposed modifications on how Canadian MAHs and license holders perform summary reporting tasks in a uniform, reliable and verifiable manner that ensures adherence to post-market surveillance responsibilities.
Register for this webinar to learn how the updated summary reports guidance will affect compliance for drug products and natural health productsBesides offering direction to market authorizatio.
Keywords: Annual Summary Reports, ASR, Clinical Research, Drug Development, Health Canada Inspections, PBRER, Periodic Risk Benefit Evaluation Report, Periodic Safety Update Report, PSUR, Regulatory, Regulatory Compliance, Toxicology/Safety