title: Regulatory approval time for hormonal contraception in Canada, the United States and the United Kingdom, 2000-2015: a retrospective data analysis.
abstract: BACKGROUND
  Access to a wide range of contraceptive methods improves prevention of unintended pregnancy by ensuring the best method fit for each individual. We compared approval times of new hormonal contraceptives by Health Canada, the US Food and Drug Administration (FDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
  
  
  METHODS
  We obtained dates of applications to Health Canada, the FDA and the MHRA for contraceptive methods approved from January 2000 to January 2015. We used public data sources and direct correspondence, and excluded generic versions of previously approved drugs. The primary outcome of interest was median time to approval for novel hormonal contraceptives. Secondary outcomes included the median time to approval for all hormonal contraceptives and the number of approved hormonal contraceptives comparing countries studied, as well as the median time for approval of novel compared with nonnovel hormonal contraceptives within each country.
  
  
  RESULTS
  During this period 16 contraceptives were approved in Canada, 26 in the US and 14 in the UK. Applications for novel contraceptives were initiated later in Canada, and time to approval was longer in Canada than in the US (p= 0.03). The median time to approval for all contraceptives in Canada was 529.5 (interquartile range [IQR] 420.8 to 784.0) days, compared with 396.0 (IQR 308.0 to 594.5) days in the US and 341.0 (IQR 244.8 to 512.2) days in the UK. No subdermal implant contraceptives are approved in Canada.
  
  
  CONCLUSIONS
  Canadian women wait longer for novel contraceptive methods and have fewer options. Canada could improve population health by addressing the regulatory barriers associated with the unmet need for contraception. Facilitation for approval of a contraceptive implant, and improvement to prolonged novel drug approval times, could support Canadians to plan and space their pregnancies.
authors.affiliation: Faculty of Pharmaceutical Sciences (Troskie, Soon), University of British Columbia; Contraception Access Research Team (Troskie, Soon, Albert, Norman), Women's Health Research Institute; Department of Family Practice, Faculty of Medicine (Soon, Norman), University of British Columbia, Vancouver, BC.
authors.forename: Christine
authors.initials: C
authors.lastname: Troskie
authors.affiliation: Faculty of Pharmaceutical Sciences (Troskie, Soon), University of British Columbia; Contraception Access Research Team (Troskie, Soon, Albert, Norman), Women's Health Research Institute; Department of Family Practice, Faculty of Medicine (Soon, Norman), University of British Columbia, Vancouver, BC.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Soon
authors.affiliation: Faculty of Pharmaceutical Sciences (Troskie, Soon), University of British Columbia; Contraception Access Research Team (Troskie, Soon, Albert, Norman), Women's Health Research Institute; Department of Family Practice, Faculty of Medicine (Soon, Norman), University of British Columbia, Vancouver, BC.
authors.forename: Arianne Y
authors.initials: AY
authors.lastname: Albert
authors.affiliation: Faculty of Pharmaceutical Sciences (Troskie, Soon), University of British Columbia; Contraception Access Research Team (Troskie, Soon, Albert, Norman), Women's Health Research Institute; Department of Family Practice, Faculty of Medicine (Soon, Norman), University of British Columbia, Vancouver, BC.
authors.forename: Wendy V
authors.initials: WV
authors.lastname: Norman