Guidance Documents

The following guidance documents have been prepared to assist in the interpretation of the policies governing statutes and regulations.

• Blood Submission Status
• Clinical Trials
• Cost Recovery
• Drug Interactions
• Drug Submission Status
• Drugs Currently Regulated as New Drugs
• Facility Information
• Good Manufacturing Practices
• Guidance Document: Schedule A and Section 3 to the Food and Drugs Act
• Homeopathics
• ICH
• Lot Release
• Management of Drug Submission
• Notice of Compliance with Conditions
• Official Methods
• Patented Medicines
• Pharmacogenomics
• Plasmapheresis
• Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form
• Preparation of Drug Submissions
• Priority Review
• Quality
• Radiopharmaceuticals
• Semen Special Access Program
• Subsequent Entry Biologics (SEBs)