ARCHIVED - Legislation and Guidelines - Biologics, Radiopharmaceuticals and Genetic Therapies - Health Canada

Health Canada is actively involved in a number of global initiatives to support and enhance our regulatory framework related to biologics, radiopharmaceuticals and genetic therapies.

What information can you find here?

This section contains links to information on legislation and guidelines related to biologics, radiopharmaceuticals and genetic therapies.

Acts & Regulations

• Canada Gazette Part I
• Canada Gazette Part II
• Notices & Early Consultation

Guidance Documents

• Facility Information
• Lot Release
• Preparation of Drug Submissions
• Quality
• Radiopharmaceuticals
• Semen Special Access Program
• Vaccine regulation