What is the Yearly Biologic Product Report (YBPR)?
The Yearly Biologic Product Report (YBPR) is a report that must be submitted annually by manufacturers of all Schedule D (Biologic) drugs in accordance with Guidance for Sponsors: Lot Release Program for Schedule D (Biologics) Drugs. The report contains production information on both drug substance and drug product lots, including test methods and results, reasons for any recalls and corrective action taken, as well as other pertinent post-market information. Health Canada has the authority to request aYBPR based on section C.01.014.5, C08.007 and/or C.08.008 of the Food and Drug Regulations, which requires manufacturers of Schedule D (biologic) drugs to provide information annually to Health Canada. Section C.04.015 of the Food and Drug Regulations requires manufacturers to provide information supporting Lot Release.
