Good pharmacovigilance practices guidelines (GUI-0102): References
Laws and regulations
Health Canada policies
- Compliance and enforcement policy for health products (POL-0001)
- Inspection strategy for good pharmacovigilance practices for drugs (POL-0041)
Health Canada guidance documents
- Risk classification of Good Pharmacovigilance Practices observations (GUI-0063)
- Guidance document for industry – Reporting adverse reactions to marketed health products
- Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry
- Guidance on notifying Health Canada of foreign actions
- Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products – Guidance for industry
- Guidance on the Food and Drug Regulations for public health emergency drugs
- Submitting risk management plans guidance document
- Guidance Document: Product Monograph
- Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Guidance document: Administrative processing of submissions and applications involving human or disinfectant drugs
Other Health Canada guidance documents and databases
- The drug and health products inspections database (DHPID)
- Compliance and enforcement policy framework
International guidance documents
- Periodic Benefit-Risk Evaluation Report (ICH E2C(R2)) (PDF)
- Post-approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICH E2D(R1)) (PDF)
- MedDRA Support Documentation
- Council for International Organizations of Medical Sciences (CIOMS) Form I (PDF)
- Practical Aspects of Signal Detection in Pharmacovigilance (CIOMS Working Group VIII) (PDF)
- CIOMS Cumulative Pharmacovigilance Glossary (Version 1.0) (PDF)