What is a Summary Basis of Decision?
A Summary Basis of Decision (SBD) is a document that outlines the scientific and benefit/risk based considerations that factor into Health Canada’s decision to grant market authorization for a drug or medical device. The document includes regulatory, safety, efficacy and quality (chemistry and manufacturing) considerations. • What is a Notice of Decision? A Notice of Decision (ND) is a one-page summary outlining the authorization received and general information related to the drug or medical device. NDs will be published independently within approximately two weeks of Notice of Compliance or medical device licence issuance. When the SBD is published, the ND will be incorporated into the SBD as Section 2. NDs will be published for the same scope of submissions as SBDs. • 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 professional
