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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GVP inspections

In Canada, establishments that sell drug products are regulated by the Food and Drugs Act and Food and Drug Regulations.

This act and its associated regulations:

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:

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:

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:

The overall rating indicates whether the establishment is compliant or non-compliant with the:

The rating is based on observations noted by the inspector and includes:

Compliant rating

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.

Non-compliant rating

A non-compliant rating could mean that:

We may:

If non-compliance leads to a potential health risk to Canadians, an assessment of the approval to market will be conducted.

Ongoing follow-up

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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2016-10-28