Background: The median time to approval of new drugs in Canada decreased considerably in the mid-1990s, although it continued to be longer than in such countries as Australia, Sweden, the United Kingdom, and the United States. Ongoing concern about approval times pointed to a need for a further international comparison.
Objective: This study was designed to assess whether there have been continuing improvements in drug approval times in Canada relative to these other countries.
Methods: Application and approval dates of new chemical or biological substances approved for marketing from 1999 through 2001 were requested from the Canadian, Australian, and Swedish regulatory agencies. Information for the United States was derived from publications of the Pharmaceutical Research and Manufacturers of America. The regulatory agency for the United Kingdom does not release application dates, although these were the same as the Swedish application dates for most drugs approved in both countries through the centralized European Union (EU) review procedure. Application dates for drugs licensed under the EU mutual-recognition arrangement or in the United Kingdom only were requested from the relevant pharmaceutical companies.
Results: One hundred eighty-six new drugs were approved in >/=1 of the countries studied between January 1999 and December 2001: 17 (9.1%) in all 5 countries, 25 (13.4%) in 4, 27 (14.5%) in 3, 39 (21.0%) in 2, and 78 (41.9%) in 1. Approval times were longer in Canada than in Australia, although not significantly so (median time, 645 and 551 days, respectively). Canadian and Australian approval times were significantly longer than those in Sweden (431 days), the United Kingdom (479 days), and the United States (371 days) (P < 0.001). The annual median approval time in Canada increased in each of the 3 years. The approval times of priority-reviewed drugs in Canada were significantly longer than in the United States (median 317 vs 232 days) but significantly shorter than in Australia (509 days) (both comparisons, P < 0.001).
Conclusions: Overall approval times of new drugs in Canada were longer than those in Australia, Sweden, the United Kingdom, and the United States in the period studied. The findings warrant ongoing monitoring of Canadian drug approval times.