Background

In Canada, drugs are regulated under federal statutory and regulatory provisions set out in the 1960s. Since then, the development of drugs by the modern pharmaceutical and biotechnology industries has grown increasingly complex. The recent advancements in science, medicine, and technology are having an impact on drug licensing in Canada.

The Progressive Licensing Project was initiated to look closely at the entire federal drug licensing system, from early clinical trials to market authorization, and then the monitoring of drugs once they are on the market. The following subsections provide a general description of the history of Canadian drug regulation, describe some of the drivers behind the Progressive Licensing Project, and supply details about the project and the main themes upon which it is based:

Brief History

Drug regulation in Canada began in the late nineteenth century and the current system was in place by the end of the twentieth. This section describes the development over time of the regulatory system for drugs.

Trends and Drivers

This section explores some of the changing trends and pressures that have an impact on a drug licensing system, which include changes in public expectations, new developments in technology and medical practice, and shifts in the focus of regulatory agencies worldwide.

About the Project

This section provides some details about the project, the team behind it, and its position within Health Canada.

Themes

The new framework is based on the fact that knowledge about a drug progresses over time. From this central concept flow the four main themes: a life-cycle approach to drugs; an evidence-based approach to decisions; and an approach based on good planning and accountability.

Glossary

The glossary contains brief descriptions of commonly used terms and concepts related to the drug regulatory system in Canada.

Contact information for the Progressive Licensing Project.