If Canada does not publish SBDs for negative decisions, how will consumers be informed should Health Canada not approve a drug for a new use due to safety concerns?
The SBD is intended to reflect the information available to the regulator at the time of authorization. It is not intended to be a vehicle for communicating all important up-to-date safety information on a product. Such information is communicated through the issuance of a Dear Health Professional Letter and Public Advisories as appropriate. • Will the SBDs contain comparisons of the drug to other available therapies for the same use? The SBDs may on occasion provide comparative information between available therapies if the clinical trials submitted in the application were so designed. If the sponsor has made a claim of superiority over other available therapies, the SBD would include Health Canada’s review of the supporting data. • Is Canada the only country to publish SBDs? The European Medicines Agency (EMEA) publishes European Public Assessment Reports (EPARs) for all products approved through the centralized procedure, thereby providing a similar level of information to the SBD.
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