Submitting risk management plans guidance document: Resources
Submission process and content
- Filing submissions electronically
- Guidance document: Product monograph
- Fees for the review of drug submissions and applications
- Guidance document for industry – Review of drug brand names
- Guidance document: Labelling of pharmaceutical drugs for human use
- Post-notice of compliance (NOC) changes: Safety and efficacy document
- Guidance for industry: Management of drug submissions and applications
- Preparation of drug regulatory activities in the common technical document (CTD) format
Pharmacovigilance and other practices and standards
- Reporting adverse reactions to marketed health products
- Good pharmacovigilance practices (GVP) guidelines (GUI-0102)
- Labelling requirements for non-prescription drugs guidance document
- Good label and package practices guide (GLPPG) for prescription drugs
- Draft guidance document – The use of foreign reviews by Health Canada
- Notifying Health Canada of foreign actions – Guidance document for industry
- Good label and package practices guide for non-prescription drugs and natural health products
- Guidance document – Submission and information requirements for extraordinary use new drugs (EUNDs)
- Preparing and submitting summary reports for marketed drugs and natural health products – Guidance document for industry
- Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products - Guidance for industry
- Notice: Adoption of the International Conference on Harmonisation (ICH) guidance on periodic benefit risk evaluation report – ICH topic E2C(R2)
- Notice: Implementation of risk management planning including the adoption of International Conference on Harmonisation (ICH) guidance Pharmacovigilance planning – ICH topic E2E
International Conference on Harmonization (ICH) guidance documents
Find the following guidance documents by accessing the International Conference on Harmonization (ICH) website:
- ICH E2C-R2: Periodic benefit-risk evaluation reports (PBRERs)
- ICH E2E: ICH harmonized tripartite guideline: Pharmacovigilance planning E2E
European Medicines Agency guidelines
Find the following guidelines by accessing the European Medicines Agency (EMA) website:
- Guidance on format of the risk management plan in the EU – in integrated format
- Guideline on good pharmacovigilance practices: Module V – Risk management systems
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