Biologics, Radiopharmaceuticals and Genetic Therapies

Health Canada works to maximize the safety and effectiveness of biologics, including vaccines and biotechnology products, as well as, radiopharmaceuticals in the Canadian marketplace and health system.

What information can you find here?

This section contains links to reports and publications related to Biologics, Radiopharmaceuticals & Genetic Therapies.

• BGTD 2008 Retrospective Review
• (2005) A Coordinated and Comprehensive Donation and Transplantation Strategy for Canada
• Announcements
• Fact Sheets
• Consultation
  • (2008) Consultation on the Regulatory Framework for Subsequent Entry Biologics - Summary Report
  • (2007) Stakeholder Consultation on the Proposed Regulatory Framework for Blood and Blood Components: Consultation Report
• Guidance Documents
  • (2007) Good Guidance Practices
• Summary Basis of Decision documents are available, which outline the scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization for a drug or medical device.