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abstract
BACKGROUND
The
drug approval timeline is a lengthy process that often varies between
countries. The objective of this study was to delineate the Canadian
drug approval timeline for oncology drugs and to compare the time to
drug approval between Health Canada (HC) and the US Food and Drug
Administration (FDA).
METHODS
In
total, 54 antineoplastic drugs that were approved by the FDA between
1989 and 2012 were reviewed. For each drug, the following milestones
were determined: the dates of submission and approval for both the FDA
and HC (Health Canada) and the dates of availability on provincial drug formularies in
Canadian provinces and territories. The time intervals between the
aforementioned milestones were calculated.
RESULTS
Of
54 FDA-approved drugs, 49 drugs were approved by HC at the time of the
current study. The median time from submission to approval was 9 months
(interquartile range [IQR], 6-14.5 months) for the FDA and 12 months
(IQR, 10-21.1 months) for HC (P < .0006). The time from HC
approval to the placement of a drug on a provincial drug formulary was a
median of 16.7 months (IQR, 5.9-27.2 months), and there was no
interprovincial variability among the 5 Canadian provinces that were
analyzed (P = .5).
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