How soon after a drug or device is approved can I find the corresponding SBD?
Health Canada aims to publish SBDs within 4 months of Notice of Compliance (NOC)/licence issuance. • Where can I find SBDs? SBDs will be publicly available on the Health Canada website under the Therapeutic Products Directorate (TPD) and Biologic and Genetic Therapies Directorate (BGTD) webpage links. They will accompany posting of related product-specific information concerning issuance of market authorization on the NOC database (drugs) and the Medical Device Application Line Listings (MDALL) database (devices). • Who prepares the SBDs? Technical editors draft the SBDs directly from the Health Canada review reports, vetting all information for accuracy with the responsible review authority. • Will I understand the SBD? Who is the intended audience? SBDs are written for all Canadians interested in the reasons why Health Canada has taken product-specific decisions for drugs and medical devices. The documents are drafted in technical language and although an accompanying Readers’ Guide
