Closed consultation: Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products

Health Canada held 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 sought feedback on the proposed changes. We invited stakeholders to provide their comments on the draft guidance document and draft notification form for our consideration before finalizing this guidance.

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)

Contact us

Office of Policy, Risk Advisory and Advertising (OPRAA)
Marketed Health Products Directorate
Health Canada
Email: mhpdpolicy-politiquesdpsc@hc-sc.gc.ca