Guidance on preparing and submitting summary reports for marketed drugs and natural health products: Issue-related and interim summary reports
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Issue-related summary reports (FDR)
The issue-related summary report (IRSR) is a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to a drug that are known to the manufacturer and that concern a specific issue identified by the Minister.
Health Canada may ask the manufacturer of a drug to submit an IRSR if we wish to assess the drug's safety and effectiveness. This is set out in C.01.019(1) of the Food and Drug Regulations (FDR).
Content of an IRSR
An IRSR should consider the following:
- actions already taken in relation to the issue
- medical definition of the adverse reactions related to the subject of the report
- description of the search strategy to retrieve the cases (for example, from databases)
- detailed summary analysis of the cases, which should include the following information:
- tabulation of all events
- your comments on the cases
- summary analysis of the temporal relationship between product administration and the occurrence of the event
- summary analysis of possible risk factors and confounding variables
- summary of medication errors, including incidents without clinical consequences
- Canadian and international patient exposure data using both patient-years and total number of patients exposed, if available
- core reference safety information, approved product labels or other documentation that reflects Canadian market entry requirements
- reference safety information includes company core safety information, company core data sheet
- other documentation includes product monograph, labelling standard or approved labelling information
- conclusion on the product's safety and effectiveness related to the occurrence of these events and, if applicable, any planned risk mitigating actions or change to the risk management plan (RMP), product monograph, labelling, packaging or product design
You may include additional information in the IRSR relevant to the analysis of the specific issue.
If we require other specific information, we will stipulate this in the request letter.
Submission of issue-related summary reports
We will issue a request for an IRSR in writing. You will have an opportunity to provide comments on the period or the requested data outlined in the request letter for the submission of the report.
In general, IRSRs are to be submitted within a 30-day period. However, we may require the information within less than 30 days if it is needed to determine whether the drug poses a serious and imminent risk to human health.
Provide the IRSR in either English or French.
Submit the IRSR in an electronic common technical document (eCTD) or non-eCTD format via the electronic submissions gateway (ESG) using the regulatory enrolment process (REP).
For information on transactions in eCTD or non-eCTD format, consult:
Contact us if you have questions about your submission.
Interim summary reports (NHPR)
We may request an interim summary report if we believe the natural health product (NHP) is no longer safe when used under the recommended conditions of use. This is set out in subsection 24(3) of the NHPR. We will inform you of the request in writing.
Since the date of the most recent summary report, the interim summary report must contain a concise critical analysis of all:
- adverse reactions that occurred in Canada
- serious adverse reactions that occurred in Canada and serious unexpected adverse reactions that occurred inside or outside of Canada
- during the previous 12 months and
- at a dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying organic functions in humans
Submission of interim summary reports
Interim summary reports are to be submitted within a 30-day period.
Interim summary reports should be provided to Health Canada in either English or French.
For NPN or DIN-HM products, our request letter will outline instructions on how to submit the ISR.
Contact us if you have questions about your submission.