About good pharmacovigilance practices (GVP) inspections
Any drugs sold to Canadians must remain safe and effective after they are approved for prescription and sale. Learn about good pharmacovigilance practices (GVP) and how Canada conducts GVP inspections.
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This act and its associated regulations:
- allow us to monitor the sale and importation of drugs in Canada
- require drug establishments to:
- monitor the ongoing safety of the drug
- report any adverse drug reactions (ADRs) to the federal government
Through the GVP inspection program, we can help to ensure that establishments are continually evaluating the safety and effectiveness of drugs. The goal of a GVP inspection is to assess whether a drug establishment is following post-approval regulatory requirements. These requirements are outlined in the Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102). They include preparing:
- ADR reports
- annual summary reports after a drug has been approved
All market authorization holders or importers who sell drug products in Canada are subject to a GVP inspection. This is because the names of these establishments appear on the labels of drugs sold in Canada. As such, they are likely to receive notifications of ADRs that must be monitored and reported to us.
GVP inspections help ensure drug establishments put in place and maintain a strict ADR management program. Establishments must keep their ADR records and annual summary reports for 25 years. This allows us to monitor drug reactions over time and request label changes.
What is pharmacovigilance?
Pharmacovigilance is the practice of monitoring the effects of medical drugs after they have been approved for use and sale.
What are adverse drug reactions?
An adverse drug reaction can happen when a drug is taken, and can include reactions that are:
What is an annual summary report?
An annual summary report describes whether what is known about a drug's risks and benefits has changed over the past year.
What inspectors look for
Inspectors review the drug establishment's records and procedures to assess compliance, including processes for:
- receiving, analyzing, submitting and maintaining records about:
- unusual failures in effectiveness of new drugs
- preparing annual summary reports and issue-related summary reports
Inspectors make "observations" when they note areas where the establishment is not meeting regulatory requirements. Each observation is classified by level of risk:
What is an unusual failure in effectiveness?
An unusual failure in effectiveness is when a health product fails to produce the expected intended effect. This may involve a negative health outcome, including a worsening of the condition the drug was meant to treat.
After a GVP inspection
After completing the inspection, the inspector creates a report that:
- documents the findings
- communicates to the establishment the:
- issues an overall inspection rating to the establishment
The overall rating indicates whether the establishment is compliant or non-compliant with the:
- Food and Drugs Act
- Food and Drug Regulations
The rating is based on observations noted by the inspector and includes:
- the number of observations
- risk level of each observation
A compliant rating means the establishment is complying with the Food and Drugs Act and associated regulations with respect to GVP.
An establishment may receive a compliant rating even if a number of observations have been identified. This is because the rating also takes into consideration the level of risk.
Establishments will need to take corrective actions to address any observations.
A non-compliant rating could mean that:
- the establishment:
- has not shown that its activities comply with the Food and Drugs Act and Food and Drug Regulations
- will need to take immediate corrective actions
- safety information is missing which could lead to serious health risks for Canadians
- request corrective actions be implemented immediately
- conduct a re-inspection to evaluate corrective actions taken
If non-compliance leads to a potential health risk to Canadians, an assessment of the approval to market will be conducted.
Where possible, establishments are given the opportunity to correct observations during an inspection. If they are not able to, they must then take corrective actions after the inspection to address the observations.
Establishments must provide us with a written corrective action plan for any observations identified, including target dates for completion.
We may conduct a follow-up inspection to make sure the corrective actions have been taken.
When needed, we will consider enforcement actions, as outlined in the Compliance and Enforcement Policy (POL-0001).
Inspection report cards
We post detailed report cards for GVP inspections. Each report card summarizes the inspection observations and ratings:
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