Legislation and Guidelines

Acts and Regulations

The Biologics and Genetics Therapies Directorate (BGTD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the biologic or radiopharmaceutical drug and medical device combinations offered for sale in Canada are safe, effective and of high quality. The BGTD also administers fee regulations for drugs and medical devices under the authority of the Financial Administration Act. All Federal Acts and associated Regulations are available on the Justice Canada Web site.

• Interim Orders
• Notices and Early Consultation
• Canada Gazette Part I
• Canada Gazette Part II

Additional Resources

• Guidance Documents
• Policies