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.

Speakers

Agnes Jankowicz, Vice President of Pharmacovigilance, ClaroPV Services Inc.

Agnes Jankowicz is an industry leader with over twenty years of experience in pharmacovigilance (PV) and medical information (MI), both in the pharmaceutical industry and consulting. She is a Vice President of Pharmacovigilance at ClaroPV, whose team includes experienced and dedicated PV & MI professionals. Agnes is an expert PV auditor and a recognized pharmacovigilance educator, teaching pharmacovigilance courses and presenting on various PV topics. Agnes holds a graduate degree in Pharmacology & Toxicology and, before joining the pharmaceutical industry, was involved in academic research.

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Anna Bussel, Vice President, Pharmacovigilance and Medical Information, ClaroPV Services Inc.

Anna Bussel is a pharmaceutical professional with over 15 years of experience in pharmacovigilance (PV), regulatory affairs (RA) and quality assurance (QA). She is a Vice President of Pharmacovigilance and Medical Information at ClaroPV Services Inc. Her career spans both the pharmaceutical industry, where she held PV, RA and QA roles at Eli Lilly and Company, and consulting, where she headed the PV & MI Department, providing strategic PV & MI advice to multiple clients. She has led numerous GVP and GMP audits on behalf of Marketing Authorization Holders and liaised with Health Authorities on market access and drug policy improvements. Anna holds a Master’s in Pharmacy and is an active member of the DIA.

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