Quality

The Biologics and Genetic Therapies Directorate has developed a number of technical guidances, Directives, and Notices, pertaining to the Quality (Chemistry and Manufacturing) information associated with specific products which we regulate under the authority of the Food and Drug Regulations and Act. These documents are intended to assist stakeholders with developing their operations, products, and/or in preparing drug submissions to meet current regulatory requirements or objectives. For additional information, please contact the appropriate division within the Biologics and Radiopharmaceutical Evaluation Centre.

• Draft Guidance Document - Drug Master Files (DMFs)
  Date: 2008-09-05
• Draft Help Notes for Completing the Quality Information Summary-Biologicals (QIS-B) and Certified Product Information Document- Biologicals (CPID-B) Templates
• Notice- Electronic Templates for the Quality Information of Drug Submissions for Biological Products and Radiopharmaceuticals
  Date: 2004-09-01