On June 13, 2009, proposed regulations amending the Food and
Drug Regulations with respect to adverse drug reaction
reporting (Proposed Regulations) were published in the Canada
Gazette. The Proposed Regulations permit more rigorous monitoring
of drug safety by the Minister of Health and bolster the
Minister's ability to enforce Canada's reporting
requirements for adverse drug reactions.1
Under the current regulations, manufacturers are required to
submit a case report to the Minister within 15 days of becoming
aware of any serious adverse drug reaction associated with a drug.
Manufacturers must also prepare an annual summary of all adverse
events associated with the drug, but there is no requirement to
actually submit this summary to Health Canada
unless it makes a determination (based on
other information that it has gathered/been provided) that the drug
may not be safe.
The Proposed Regulations will require manufacturers to
determine, in preparing their annual summary report, whether a
significant change has occurred in the risk-benefit profile of the
drug since the last annual summary report. If the manufacturer
concludes that a significant change has occurred, it must notify
the Minister without delay. The Proposed Regulations will also
allow the Minister to request annual summary reports and case
reports if the Minister decides to examine the safety and
effectiveness of the drug. Generally, the manufacturer must comply
with this request within 30 days, but the Minister may set a
shorter deadline if he or she has reasonable grounds to believe
that the drug may pose a serious and imminent risk to human
The Proposed Regulations do not indicate whether the Minister
will publish the manufacturer's reports, or summaries thereof,
on the Health Canada website. Presumably, the reports may be
subject to access requests via the Access to Information
In the United States, drug manufacturers must submit annual
reports to the Food and Drug Administration (FDA) containing a
"brief summary of significant new information from the
previous year that might affect the safety, effectiveness, or
labelling of the drug product."2 This is quite
different from the standard imposed by the Proposed Regulations.
The amendment would require more frequent and timely reporting in
Canada (it is expected that an average of 10–15 reports
would occur per year).
Note that there are proposed amendments to the U.S. regulations
that would require manufacturers to notify the FDA of safety
findings as they occur. If the Proposed Regulations come into force
before any amendment to the U.S. regulations, there may be
significant implications for the pharmaceutical industry. First,
Health Canada may become aware of safety issues before the FDA
does, and so may attempt to drive corrective action. Second, the
fact that a Canadian manufacturer has reported a "significant
change" in the risk-benefit profile may be alleged to be an
admission regarding safety in the context of product liability
litigation. This could spur class action suits regarding drugs that
have been the subject of Canadian adverse event reports.
Stakeholders are invited to send written comments on the
Proposed Regulations to Health Canada until August 12, 2009.
Manufacturers that have submitted comments on the proposed
amendments to the U.S. regulations may wish to submit corresponding
comments to Health Canada.
1. Regulations Amending the Food and Drug Regulations
(Adverse Drug Reaction Reporting),
C. Gaz. 2009.I.1748.
2. Ibid. at 1750.
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