Health Canada drug approval process slower than in Europe and US

Issue: BCMJ, vol. 55, No. 5, June 2013, Pages 234-235 News

A new report from the Fraser Institute shows that it takes Health Canada nearly a year to grant marketing ap­proval to prescription drugs. According to the report, entitled Federal De­lays in Approving New Medicines 2013, Health Canada took a median of 355 days to issue a Notice of Compliance certifying new patented medicines as safe and effective in 2011. According to the Fraser Institute, medicines are often approved faster in Europe and the United States. 

In 2010, Health Canada approval was 448 days compared with 319 at the European Medicines Agency. Health Canada also took longer to approve new medicines than did the US Food and Drug Administration (FDA) in 4 out of 5 years from 2007 to 2011. The largest gap was in 2010, when Health Canada approval was 448 days compared with 299 at the FDA. 

The report suggests that Canada’s federal government could improve access to new medicines through harmonization and mutual recognition with international regulatory agencies.

The report can be viewed at www.fraserinstitute.org/research-news/display.aspx?id=19592.

. Health Canada drug approval process slower than in Europe and US. BCMJ, Vol. 55, No. 5, June, 2013, Page(s) 234-235 - News.


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