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Abstract
To evaluate the timeliness of the Canadian drug review process, data on approval times of nonbiologic new chemical entities approved between 1992 and 1995 were obtained for Canada, Australia, and Sweden from their national drug regulatory agencies, for the United States from Tufts University's Center for the Study of Drug Development, and for the United Kingdom from the Centre for Medicines Research International. The information was augmented by a survey of companies performed by the Pharmaceutical Manufacturers Association of Canada. The overall Canadian median approval time (917 days) was significantly longer (p < 0.001) than those of all the other countries: Australia (620), Sweden (368), the United Kingdom (542), and the United States (623). On a yearly basis, approval times in Canada were significantly longer in 1992-1994, but the median time improved in 1995 to 650 days, which was not significantly different from any of the other countries (562, 444, 439, and 464 days, respectively). Further work is required, however, to achieve established review time performance targets and to reduce approval times in all therapeutic classes.
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