Vanessa’s Law Confronts New Drug Safety Assessment Response

Canadians who use medications to improve or maintain their health and wellbeing rely on Health Canada to continue to monitor the safety of drugs it has authorized for use in Canada, and to take prompt action if new risks are identified.

To further advance these efforts, Health Canada is proposing new regulations that would allow it to identify, assess and respond more quickly and effectively to safety issues that emerge after a drug comes on the market.

Under these proposed regulations, Health Canada would be able to require companies to conduct new tests or studies, or to compile new information and report back to the Department.

Companies will also be required to notify Health Canada of any actions requested or required by a regulator in another jurisdiction such as risk communications, label changes, recalls, or licence suspensions. Failure to comply could result in companies being subject to increased fines and penalties which have already come into force under Vanessa’s Law.

When the regulations are finalized, these provisions of Vanessa’s Law (the Protecting Canadians from Unsafe Drugs Act) that did not come into effect immediately when the law was passed will come into force.

These changes will lead to improved patient safety and better health outcomes for Canadians.

(Source: Health Canada)