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Health Canada Responds to the Report of the Interim Auditor General Chapter 4: Regulating Pharmaceutical Drug

Statement
2011-157
November 22, 2011
For immediate release

OTTAWA - Canada has one of the safest and most rigorous drug safety systems in the world. Health Canada is constantly looking for ways to strengthen it, which is why we take the findings of the Interim Auditor General seriously.

It is important to note that the report did not question the safety or effectiveness of drugs authorized by Health Canada. Rather, it identified ways Health Canada can strengthen and improve processes that are already in place.

The Department agrees with the 10 recommendations and we are already taking action to implement all of them. Clear and specific timelines for action have been adopted that will be used to measure and report progress.

Health Canada is already the only drug regulator in the world that has adopted performance standards both for completing drug reviews before a drug is authorized and for completing safety assessments while a drug is on the market.

During the audit period and since that time, we have taken important steps to improve performance.

We took a major step forward with the introduction of increased industry user fees. These came into effect in April 2011, after the audit period.  User fees are charged to companies for regulatory services and activities, such as evaluating drug submissions, performing inspections, issuing licenses, and monitoring drug safety. Charging fees reduces the burden on taxpayers and ensures that industry helps support services received from Health Canada.

The Auditor General previously called upon Health Canada to make this change. With the updated industry user fees now in place, Health Canada will invest new resources in more efficient drug product reviews, enhanced drug safety monitoring, and inspections.

As the Interim Auditor General noted, Health Canada actively monitors the safety of drugs on the market and we have increased the amount of information we disclose on approved drugs.

We have committed to improving transparency and public access to clinical trial and drug submission information so that patients and health providers can make better informed health decisions. 

For example, consultations are underway on expanding the information we make available to include decisions around drug approvals with conditions and rejections/withdrawals of drug submissions for marketed products. The goal is to make more information available by June 2012.

Health and safety is our top priority.  We have highly qualified professionals and scientists whose sole goal is to help ensure the drugs authorized in Canada are safe, effective and of high quality.

As an added step to further enhance drug safety, the Government of Canada recently provided $17.5 million to the Canadian Network for Observational Drug Effect Studies (CNODES). Part of the Drug Safety and Effectiveness Network, CNODES will increase Canada's capacity to collect data about the safety and effectiveness of medications on the market, and make better information available to medical professionals and decision-makers.

Implementing the Interim Auditor General's recommendations will build on Health Canada's commitment to work smarter and better, in ways that are more consistent, efficient and transparent. 

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