title: Comparison of oncology drug approval between Health Canada and the US Food and Drug Administration.
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 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).
  
  
  CONCLUSIONS
  The time from HC submission to HC approval takes 3 months longer than the same time interval for the FDA. To the authors' knowledge, this is the first documentation of the time required to bring an oncology drug from HC submission to placement on a provincial drug formulary.
authors.affiliation: Department of Oncology, Tom Baker Cancer Center, Calgary, Alberta, Canada.
authors.forename: Doreen A
authors.initials: DA
authors.lastname: Ezeife
authors.forename: Tony H
authors.initials: TH
authors.lastname: Truong
authors.forename: Daniel Y C
authors.initials: DY
authors.lastname: Heng
authors.forename: Sylvie
authors.initials: S
authors.lastname: Bourque
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Welch
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Tang
mesh_terms: D000970:Antineoplastic Agents; D002170:Canada; D017277:Drug Approval; D006801:Humans; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents
keywords: Health Canada; US Food and Drug Administration; drug approval; interprovincial variability; oncology drug timeline