Summary Basis of Decision (SBD) documents explain why Health Canada authorized certain drugs and medical devices for sale in Canada. The documents include regulatory, safety, effectiveness and quality (chemistry and manufacturing) considerations.
SBDs for pharmaceuticals, biologics, and medical devices are now available exclusively on the Canada.ca website through the Drug and Health Product Register (DHPR). Click here to access the SBD search function in the DHPR. Searches can be conducted by manufacturer, medicinal ingredient, drug or device name, drug identification number, or device licence number.
Health Canada is now in Phase II of the SBD initiative. Health Canada drafts Phase II SBDs for new drug submissions for new active substances and biosimilars (previously referred to as subsequent entry biologics). Health Canada also targets to publish 5-7 Phase II SBDs per year for Class III or IV medical device applications with novel technology.
Phase II SBDs are drafted for all eligible drugs and medical devices authorized/licensed as of September 1, 2012. Eligible products authorized before September 1, 2012, but on or after January 1, 2005 have SBDs in the Phase I format.
Consult the Frequently Asked Questions document for more information on the SBD initiative.
SBDs benefit Canadians by
SBDs improve the transparency of the drug and medical device regulatory review processes. They also give Canadians improved access to information about decisions to authorize products for sale in Canada.
For an explanation of the information available in each section of a Phase II SBD, consult the Phase II Reader's Guides.
For an explanation of the information available in each section of a Phase I SBD, consult the Phase I Reader's Guides.
Development of the SBD initiative began in 2003/04, and SBDs themselves were first published in 2005. An evaluation of the SBD initiative was published in 2010, and Health Canada has now launched Phase II. For more information, please visit the Background web page.