Advice on the Regulatory Process for Canada

The following advice covers the regulatory process for vaccines and other biologics in Canada. However, advice on the regulatory process for other international markets can be given since they are similar in nature.

Advice on the Canadian regulatory process covers ...

• Structure of the regulatory authority
• Drug submission management process
• Pre-licensure meetings with regulatory authority
• Screening process for drug submissions
• Review and licensing process
• How to respond to clarifaxes subsequent to review
• Priority review status application
• Establishment licensing
• Good Manufacturing Practice Inspections
• On Site Evaluations (Product Specific Process)
• Lot release process
• Changes to marketed drugs (Supplemental New Drug submissions, Notifiable Changes and Notice of change)

Phone me to discuss any aspects of the regulatory process or return to home page.