Consultation: Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products
Current status: Open
Open on October 24, 2025, and will close to new input on December 23, 2025.
Health Canada is holding a 60-day consultation on:
- revisions to the Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry, now entitled “Guidance on preparing and submitting summary reports for marketed drugs and natural health products”
- Draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product
The purpose of this guidance is to provide market authorization holders (drugs) and licence holders (natural health products) with information on how to comply with the Food and Drugs Act (FDA), the Food and Drug Regulations (FDR), and the Natural Health Products Regulations (NHPR) with respect to the preparation and submission of summary reports for marketed health products, namely:
- Sections C.01.018, C.01.019 and C.01.020 of the FDR
- Subsections 24(2) and 24(3) of the NHPR
This guidance update is meant to:
- consolidate current guidance documents on summary reporting
- incorporate clarifications and convert to plain language
- resolve stakeholder questions and concerns
- refine interpretations and processes
- update submission processes
To enhance clarity, guidance on summary reporting for drugs and for natural health products has been separated to better address the distinct regulatory and operational considerations for these product lines.
Health Canada is seeking feedback on the proposed changes. We invite stakeholders to provide their comments on the draft guidance document and draft notification form and we will consider all input and feedback received before finalizing this guidance.
How to participate
Interested stakeholders should read and review the:
- Draft guidance on preparing and submitting summary reports for marketed drugs and natural products
- Draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product
Send an email with your comments to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca. In the subject line, use “Summary Reporting Guidance – Consultation Comments”
Deadline for feedback is December 23, 2025.
Who is the focus of this consultation
We invite all interested people in Canada and stakeholders to provide their comments, in particular:
- Market authorization holders under the FDR
- Licence holders under the NHPR
- Other industry stakeholders
Related links and information
- Existing guidance document: Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry
- Questions and Answers Regarding the Adoption of Periodic Benefit Risk Evaluation Report (PBRER) Review at Health Canada
- Annual Summary Report Checklist (including PSUR and PBRER)
Note: We are currently in the process of developing and updating other post-market vigilance guidance documents. Following final publication, these documents will provide additional guidance relevant to summary reporting. These relevant guidance documents include:
- Guidance on notifying Health Canada of foreign actions (consultation open until November 24, 2025)
- Guidance on reporting adverse reactions and unusual failure in efficacy to marketed health products (consultation planned for spring 2026)
- Good pharmacovigilance practices (GVP) guidelines (GUI-0102) (consultation open until October 30, 2025)
- Management of post-market vigilance submissions guidance
Stakeholders will have an opportunity to review these guidance documents and provide their comments in due course. We will consider comments regarding the relationship between the summary reports and these other guidance documents, where applicable.
Contact us
Office of Policy, Risk Advisory and Advertising (OPRAA)
Marketed Health Products Directorate
Health Canada
Email: mhpdpolicy-politiquesdpsc@hc-sc.gc.ca