New drug approval times and safety warnings in the United States and Canada, 1992-2011.

Background: New drug approvals in the US and Canada were reviewed in short-term studies in the 1990s. A database of drugs approved in both countries between 1992 and 2011 exists allowing for a longer time horizon to assess trends.

Objective: To compare review times of drugs approved in the US and Canada over the 20-year period and their duration on the respective markets until any serious safety risk arose.

Methods: Data on submission and approval dates and review type were obtained from the regulatory agencies.

Results: 454 drugs were approved in both countries in the 20-year period for which the US median approval time was shorter than the Canadian median by >6 months (382 versus 574 days). Nevertheless, in 2007-11, the median approval times were closer in the two countries (302 and 356 days, respectively). 3% of the drugs were discontinued for safety reasons in both countries. The 10-year survival rate without a serious safety warning was significantly lower in Canada (58.4%) than in the US (69.3%). Being approved in 2002-11 with a shorter review time had the greatest impact on a drug receiving a serious safety warning.

Conclusions: Overall, new drug approval times in the two countries in the last five years were closer, although some important differences remain so that Canadians still wait longer for some new drugs to be approved. The survival rate of a drug without a serious warning decreased substantially in the last decade in both countries, especially in drugs approved with shorter review times.