加拿大卫生部发布并实施 GUI-0102 药品优良药物警戒实践指南

Date issued: May 22, 2026
Date implemented: May 22, 2026
Replaces: Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102), implemented August 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 guide is for manufacturers or market authorization holders (MAH), who sell drugs and are responsible for post-market pharmacovigilance activities and good pharmacovigilance practices (GVP). When you sell a drug under a name you control, you meet the definition of a manufacturer.

Health Canada performs GVP inspections to assess your compliance with the following post-market pharmacovigilance and GVP requirements outlined in the Food and Drug Regulations (regulations).

• C.01.014.21
• C.01.016 to C.01.020
• C.01.050
• C.08.007(1)(h)
• C.08.008(c)
• C.08.003

It is important to implement GVP to monitor and assess the safety and effectiveness of the drug(s) you sell. GVP provides confidence that you have conducted pharmacovigilance activities in a consistent, reliable, and verifiable manner.  

Please note that this guidance document does not cover all the legislation related to post-market pharmacovigilance and safety activities and/or amendments under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) such as the Food and Drugs Act (act) sections 9, 21.1, 21.2, 21.31, 21.32, and the regulations C.01.003, C.01.004, C.01.013, C.01.014.1, C.01.052, C.01.053.

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

This guide does 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

Guidance documents help you understand how to comply with regulations for the purpose of GVP inspections. They also provide guidance to our staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

We inspect manufacturers or MAHs to assess compliance with the act and associated regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with GVP requirements.

To better understand how risk ratings are assigned during inspections, see Risk Classification of Good Pharmacovigilance Practices Observations (GUI-0063).

These guidelines are not the only way regulations can be interpreted and are not intended to cover every possible case. We may revise this guidance and adapt our policy approach as new technologies emerge and mature, and as regulatory oversight optimizes.

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.