Drug Licensing Process

This section of the Progressive Licensing Project's Web site explains the current drug review process through a series of process maps and corresponding text explanations. In addition, there are links to important documents, such as guidances and policies.

A manufacturer must submit a Clinical Trial Application (CTA) for authorization to conduct a clinical trial in Canada and submit a New Drug Submission (NDS) to Health Canada to establish that a drug is safe, efficacious, and of high quality.

The overall process can be broken down into the following stages:

• Pre-Clinical Studies
• Clinical Trial Authorization, which includes
  • Clinical Trials
    • Clinical Trial Application or CTA Amendment (Division 5)
• Special Access Program
• Submission Review, which includes
  • Regulatory Product Submission
  • Safety, Efficacy, and Quality Review
    • Drug Identification Number Application (Division 1)
    • New Drug Submission (Divisions 3, 4, and 8)
  • Market Authorization Decision
• Public Access
• Post-market, which includes
  • Surveillance, Inspection, and Investigation
    • Adverse Reaction
  • Post-market Changes
    • Drug Identification Number Change
    • Changes to a New Drug

Health Canada has regulatory authority during the following stages of the process:

• Clinical Trial Application
• Submission Review
• Post-market

Contact information for the Progressive Licensing Project.