Summary Basis of Decision (SBD)

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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.

Summary Basis of Decision Documents

The SBDs are organized alphabetically by product name for drugs and medical devices. Click the links below to access the lists of SBDs.

• Summary Basis of Decision - Drugs
• Summary Basis of Decision - Medical Devices

Health Canada has now launched Phase II of the Summary Basis of Decision project. Phase II will be effective immediately, with the publication of the Notice and the accompanying Frequently Asked Questions document and Phase II Reader's Guide - Drugs and Phase II Reader's Guide - Medical Devices on June 29, 2012. Phase II SBDs will be 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 will have SBDs in the Phase I format. Please note: with Phase II, the Notice of Decision will be eliminated.

Benefits for Canadians

SBDs benefit Canadians by

• providing information that leads to more informed decisions taken in consultation with their healthcare providers; and
• providing healthcare professionals with background information that could be relevant in treating their patients.

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.

SBD Project Development

The SBD project development began in 2003/04, and SBDs themselves were first published in 2005. An evaluation of the SBD project was published in 2010, and Health Canada has now launched Phase II of the SBD project. For more information about the project, please visit the Background web page.