Updated guidance on preparing and submitting summary reports for marketed drugs and natural health products: Notice

On this page

• Updated guidance for summary reporting requirements
• Consultations
• Implementation of the updated guidance
• Contact us

Updated guidance for summary reporting requirements

The current version of Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry was published on May 23, 2018.

An updated guidance for summary reporting will come into effect on October 1, 2026.

• Revised guidance on preparing and submitting summary reports for marketed drugs and natural health products

The updates clarify long-standing requirements to prepare annual summary reports and make clear that annual summary reports should only be provided to the Minister upon receipt of a written request from Health Canada.

The updates also describe how to notify the Minister of significant changes to what is known about the product's risks and benefits, using a new form. These updates also explain that you should notify Health Canada of a significant change only if it meets the threshold outlined in guidance, per the definition.

As part of Health Canada's red tape reduction efforts, these changes are intended to reduce burden by minimizing duplicate reporting and over-reporting.

These changes reinforce Health Canada's support for a lifecycle approach to the regulation of drugs and natural health products, within the current regulatory frameworks.

Consultations

The proposed updates were published in October 2025 for 60 days to invite comments from stakeholders.

We received a total of 132 comments from industry and other stakeholders. The key themes of these comments were:

• Clarity around criteria and formatting for Canadian-specific information
• The desirability of international alignment
• Support for a risk-based approach
• The need for clarity regarding
  • format
  • required content
  • timing of notification

We considered all comments when updating the guidance document and the relevant internal processes.

Implementation of the updated guidance

The updated guidance will take effect as of October 1, 2026.

Although we will not be holding additional formal consultations on this guidance, we may consider feedback when we review the guidance and regulations for future updates. You may submit your feedback by email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca.

Contact us

Integrated Policy and Stakeholder Engagement Section
Marketed Health Products Directorate
Health Canada
Email: mhpdpolicy-politiquesdpsc@hc-sc.gc.ca