Consultation: Guidance document updates for Good Pharmacovigilance Practices (GVP) inspections

Current status: Open

Opened on September 15, 2025 and will close to new input on October 30, 2025.

Health Canada is announcing a 45-day consultation on the drafts of the updated GVP guidance documents. After consultation, the drafts will be finalized and replace the versions previously published in 2013:

• GUI-0102: Good pharmacovigilance practices (GVP) guidelines
• GUI-0063: Risk classification guide for good pharmacovigilance practices (GVP) observations

The deadline to provide comments is October 30, 2025.

Join in: How to participate

Send us an email

Step 1

Send an email to gvp-bpv@hc-sc.gc.ca to request the consultation package. Include the subject line "Consultation for GVP guidance documents updates" in your request.

Step 2

Send an email to gvp-bpv@hc-sc.gc.ca with your comments by October 30, 2025. Comments received on or before this deadline will be taken into consideration.

Who is the focus of this consultation

This consultation invites feedback from all interested parties and stakeholders, in particular:

• market authorization holders marketing the following human drugs in Canada:
  • pharmaceutical drugs, prescription and non-prescription
  • biologics set out in Schedule D to the act, including:
    • biotechnology products
    • vaccines
    • fractionated blood products
  • radiopharmaceuticals set out in Schedule C of the Food and Drugs Act (act)
  • medical gases

Key areas for discussion

Your ideas and input are sought around the proposed updates to the guidance documents related to GVP inspections. The updates will provide additional information on GVP and regulations applicable to current inspections.

The documents for consultation include proposed updates to existing guidance documents:

1. Draft GUI-0102: Good Pharmacovigilance Practices (GVP) guidelines
2. Draft GUI-0063: Risk classification guide for Good Pharmacovigilance Practices (GVP) observations

These guidance documents are intended to promote stakeholder compliance, as well as promote consistency in inspections conducted by Health Canada.

The input gathered through this process will be considered when finalizing the guidance documents.

Related information

• Food and Drugs Act
• Food and Drug Regulations

Contact us

Health Product Compliance Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Email: gvp-bpv@hc-sc.gc.ca