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Drugs and Health Products
Guidance Documents
The following guidance documents have been prepared to assist in the interpretation of the policies governing statutes and regulations.
- Guidance Document: Determining Prescription Status for Human and Veterinary Drugs [2013-06-21]
- Prescription Drug List [2013-06-21]
- Questions and Answers - Prescription Drug List [2013-06-21]
- Consultation on the new Prescription Drug List [2012-12-24]
- Allergenic products of biological origin
- Blood
- Clinical Trials
- Cost Recovery
- Drug Submission Status Requests
- Drugs Currently Regulated as New Drugs
- Good Guidance Practices
- Good Manufacturing Practices
- Guidance Document: Schedule A and Section 3 to the Food and Drugs Act
- ICH
- Management of Drug Submission
- Notice of Compliance with Conditions
- Official Methods
- Patented Medicines
- Post-Notice of Compliance (NOC) Changes
- Priority Review
- QT/QTc Interval Prolongation
- Reconsideration of Final Decisions
- Release of the finalized Guidance Document: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice [2010-04-30]
- Subsequent Entry Biologics (SEBs)
