Good pharmacovigilance practices inspection approach policy for human drugs (POL-0041): Overview
- Date issued: May 22, 2026
- Date implemented: May 22, 2026
- Replaces: Inspection Strategy for Good Pharmacovigilance Practices (GVP) for Drugs (POL-0041) 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.
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Purpose
Pharmacovigilance is the science and activities to detect, assess, understand, and prevent adverse events and other drug-related problems. Good pharmacovigilance practices (GVP) are measures taken to facilitate pharmacovigilance activities. These practices ensure that safety data is generated in a consistent, reliable, and verifiable manner. GVP protects public health and patient safety by ensuring that drugs being sold comply with the legislation, such as section 9 of the Food and Drugs Act (act). Manufacturers or market authorization holders (MAH) who sell drugs are responsible for post-market pharmacovigilance activities and GVP. When you sell a drug under a name you control, you meet the definition of a manufacturer.
Health Canada verifies compliance with Part C, Divisions 1 and 8 of the Food and Drug Regulations (regulations). This may be done through inspections of manufacturers or MAHs.
This policy describes the inspection strategy and process on:
- domestic manufacturers or MAHs
- foreign manufacturers or MAHs
Health Canada's authority to inspect comes from section 23 of the act. Health Canada inspectors are designated under subsection 22(1) of the act.
The main objectives of Health Canada's inspection strategy are to:
- minimize the health risks of drugs sold in Canada
- assess, through inspections, the compliance of manufacturers or MAHs with GVP regulatory requirements
- take compliance and enforcement actions when needed
- support national consistency
- foster transparency with the industry, international regulatory partners, and other global stakeholders
Scope
The scope of this policy applies to manufacturers or MAHs of the following human drugs:
- pharmaceuticals 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
The scope of this policy does not include:
- 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 the scope, 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
Health Canada is committed to ensure that health products are safe for consumers to use. We work with regulated parties to manage the health-related risks and benefits of drugs by:
- minimizing health risk factors to consumers
- maximizing the safety of drugs governed by the regulatory system
- providing clear information to help consumers make informed decisions
To meet these commitments for drugs, the Regulatory Operations and Enforcement Branch (ROEB) of Health Canada performs inspections of domestic and foreign manufacturers or MAHs to enforce the regulations and verify industry compliance. This includes GVP inspections of manufacturers or MAHs inside or outside Canada and can be in the form of remote inspections, as described in Policy on accessing the premises of a regulated party remotely to verify compliance (POL-0138).
Health Canada has developed a series of guides that outline our interpretations and how to comply with the regulations. The following documents are the main documents used during GVP inspections:
- Good pharmacovigilance practices guidelines (GUI-0102)
- Risk classification guide for good pharmacovigilance practices observations (GUI-0063)
Where possible, we strive to harmonize practices with other international regulatory partners or bodies such as the World Health Organization (WHO), the Pharmaceutical Inspection Co-operation/Scheme (PIC/S), and the International Council for Harmonisation (ICH).
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.