The Timeliness of New Drug Approvals in Canada: A Rejoinder

While Canada has a delay in drug approval dates and regulatory approval times compared with countries such as the United States and the United Kingdom, evidence to show that such delays compromise therapy is lacking. Faster regulatory approval coupled with an effective postmarketing surveillance system can achieve acceptable safety results, but whether such a system is feasible in Canada is unknown. Setting priorities in reforming the Canadian drug regulatory process depends on an assessment of what the most important problems are. Such an assessment reflects the nature of policy making in Canada.