The Canadian government recently announced an amendment to the adverse drug reporting requirements.

The proposal would require manufacturers to notify the Minister of Health of any significant change in a product's benefit-risk profile. The manufacturer is to determine the significance of such change at the time of preparation of the annual summary report of adverse drug reactions.

Upon such notification, the Minister's rights to further examine the safety and efficacy of the product and to request access to adverse drug reaction case reports and summary reports are triggered.

Currently, the Minister does not have the authority to compel case reports or summary reports unless the Minister first undertakes an independent assessment to conclude that the drug may not be safe.

In addition, summary and case reports are to be retained for a period of 25 years from the date the record was created.


Comments may be submitted to the Therapeutic Effectiveness and Policy Bureau of Health Canada by August 11, 2009.