Clarification of section 4.3 (Regulatory Authority Sources) of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry

The intent of this notice is to clarify Health Canada’s expectations with respect to the re-reporting of cases identified from the Canada Vigilance (CV) Online Database by Market Authorization Holders (MAHs). In particular, this clarifies section 4.3 of the May 2018 update to the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry.

The CV Online Database contains information about suspected adverse reactions to health products received from MAHs, who are required to submit serious adverse reaction (AR) reports according to the Food and Drug Regulations, as well as from consumers and health professionals, who submit reports either directly to Health Canada or via MAHs. These individual reports may be the only source of information concerning previously undetected ARs or changes in product safety and effectiveness profiles to marketed health products. Continued monitoring of ARs is thus essential to maintain a comprehensive safety and effectiveness profile of health products made available to Canadians.

As per section C.01.017 of the Regulations, “The manufacturer shall submit to the Minister a report of all information relating to the following serious adverse drug reactions within 15 days after receiving or becoming aware of the information, whichever occurs first.”

The Canada Vigilance Program (CVP) is aware of concerns regarding increased administrative burden while complying with the Regulations as they relate to the re-reporting of ARs by the MAHs based on reports that they identified from the CV Online Database. These resubmitted reports are considered to be duplicates, meaning the patient, suspected health product(s), adverse reaction(s) and timelines are the same as those in a case that already exists in the CV Online Database. In fact, these duplicates contain less information than the original reported to the CVP as they will always lack patient identifiers and potentially medical history if the MAH has not requested a copy of the report via the Access to Information (ATI) Program.

In the event a report contains no new information relative to the causality assessment of a health product’s safety and effectiveness, MAH reports originating from the Marketed Health Products Directorate (MHPD) sources (e.g., case reports published in the Canada Vigilance Adverse Reaction Online Database, case reports published in the Health Product InfoWatch) are not required to be re-submitted to the Canada Vigilance Program by the MAH as they are already contained within the CV Adverse Reaction Database. Health Canada expects this information will continue to be captured in annual summary reports (ASRs), as highlighted in section C.01.018 of the Regulations.

As part of environmental scanning efforts, MAHs should consult the CV Online Database at each monthly update or request line-listing summaries from Health Canada to obtain reports about their marketed drugs and active pharmaceutical ingredients that were sent directly to the CVP. Regularly scanning the CV Online Database produces more comprehensive safety data for ASRs and consequently, constitutes a valuable source of additional safety information on marketed health products for Health Canada. Upon identifying cases related to their products during environmental scanning efforts, the MAH is expected to conduct their own evaluation, including a causality assessment, of these reports. Further to this evaluation, the reportability of cases should be determined based on the presence or absence of new information, in addition to applying all principles outlined in the guidance document and the Regulations pertaining to reporting requirements, including determination of seriousness, causality, and minimal criteria for submitting an AR report. For these assessments, it is recommended that the MAHs obtain copies of adverse reaction reports through the ATI Program as it contains additional information to the CV Online Database.

When cases are re-reported, MAHs should provide the Canada Vigilance Adverse Event Report (AER) number and identify Canada Vigilance as the source of the report, in order to help identify duplicate reports.

Health Canada is committed to continuously improving its systems and striving to make it easier for industry to comply with Regulations. In order to help MAHs with the identification of duplicates from the CV Online Database, Health Canada will be adding the Company number/Authority number, the Sender’s full AER Number, and the Literature Reference Title to the Canada Vigilance data extract file. MAHs will be notified of these additions once implemented.

If you have any questions or concerns regarding the above messaging and/or the Guidance Document for Industry on Reporting Adverse Reactions to Marketed Health Products, we invite you to send them to the CVP, such that they can be considered in a future document revision. All enquiries pertaining to this Notice and/or suggestions to update the Guidance Document should include the phrase: "Duplicate Reports Notice and/or Reporting AR Guidance Document for Industry Updates", in the subject line.

Email: hc.canada.vigilance.sc@canada.ca

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