Health Canada发布药物警戒规范观察项风险分级指南GUI-0063

• Overview
• Risk and rating
• Sample observations
• Glossary
• References

Date issued: May 22, 2026
Date implemented: May 22, 2026
Replaces: Risk classification guide for good pharmacovigilance practices (GVP) observations (GUI-0063), implemented February 11, 2013

Disclaimer: This document does not constitute legislation. If there is any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to help the regulated party comply with the legislation and the applicable administrative policies.

On this page

• Purpose
• Scope
• Introduction
• Notes about guidance documents in general

Purpose

This guidance document helps ensure consistency among Health Canada inspectors during good pharmacovigilance practices (GVP) inspections when:

• classifying GVP observations according to risk
• assigning an overall inspection rating to an inspection

This guidance document also informs manufacturers or market authorization holders (MAHs) of the scenarios that are considered unacceptable. These scenarios may result in:

• a non-compliant (NC) rating and/or
• compliance and enforcement actions
  • in accordance with the Compliance and enforcement policy (POL-0001)

Scope

This guide applies to all persons (individuals and companies) involved in the post-market pharmacovigilance activities for the following human drugs:

• pharmaceutical drugs, prescription and non-prescription
• biologics set out in Schedule D of the act, including:
  • biotechnology products
  • vaccines
  • fractionated blood products
• radiopharmaceuticals set out in Schedule C of the act
• medical gases

These guidelines do not apply to:

• sperm and ova
• medical devices
• veterinary products
• natural health products
• cells, tissues and organs
• whole blood and blood components
• biocides (surface disinfectant and surface sanitizers)

Although these product lines are out of scope of this guide, vigilance requirements may still apply. As the manufacturer or MAH, it is your responsibility to ensure compliance with the requirements set out within the act and regulations applicable to your products.

Introduction

During a GVP inspection, we note deviations from the Food and Drugs Act (act), Food and Drug Regulations (regulations), the Good pharmacovigilance practices guidelines (GUI-0102) and other applicable guidance documents.

These deviations appear as observations in the inspection exit notice provided to the manufacturer or MAH.

This guidance document will explain how we assign a risk to observations and how we assign an overall inspection rating. It will also provide sample observations that we may note during an inspection.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, effectiveness or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.