Health Canada's use of priority review status for drugs for unmet needs.

The processes for granting priority review status to new drug submissions in Canada and the United States are not exactly the same, but reasonable concordance should be expected since the selection criteria are similar in the two countries. This study compared new therapeutic drugs approved by both Health Canada and the Food and Drug Administration (FDA) between 2000 and 2014 to evaluate concordance on priority review status. New therapeutic drugs approved in both countries totalled 301; 86 (28.6%) and 136 (45.2%) were given priority review status in Canada and the United States, respectively, with 73 (24.3%) in both. Sensitivity and specificity were 53.7% and 92.1%. Overall concordance on review type was 74.8%. κ was 0.47 indicating moderate agreement. Agreement on review type was >70% for all drugs, except oncology therapies. Broad agreement exists between Health Canada and the FDA on drugs that should not have priority review status. Concordance on drugs that should have this status was generally satisfactory and, for critical drugs, was high. Agreement would improve if more oncology drugs received priority review status in Canada. Despite a higher number of drugs receiving priority review status in the United States, there is reasonable concordance between the two countries.