Why was the SBD initiative undertaken?
The SBD initiative was undertaken in response to Health Canada’s commitment to enhance the transparency of the drug and medical device review process. Canadian health professionals frequently rely on foreign approval packages/basis for information about decisions as there is no similar information disseminated in Canada at this time. These approval packages may be inconsistent with the regulatory decisions made in Canada and may not provide information appropriate to the Canadian context. • Will SBDs be drafted for all authorized products? No. SBDs will be implemented in a phased approach beginning with novel drug therapies (New Active Substances) and a subset of Class IV medical device licence applications in January 2005. Once Health Canada have appropriately evaluated the outcomes of Phase I, implementation of Phase II will begin. Phase II will include the drafting of SBDs for an expanded set of drug submissions, including supplements and generic submissions, as well as additional m
