Health Canada takes longer to approve new drugs than European and US counterparts

Canadian medicines regulator Health Canada takes nearly a year to grant marketing approval to prescription drugs while new medicines are often approved faster in Europe and the USA, according to a new report from the Fraser Institute, an independent, non-partisan Canadian public policy think-tank.

Federal Delays in Approving New Medicines calculates that Health Canada took a median of 355 days to issue a Notice of Compliance certifying new patented medicines as safe and effective in 2011.

"These new drugs have already passed extensive clinical trials in accordance with international safety standards, and are reviewed by European and American agencies for safety and efficacy. But Health Canada holds them in bureaucratic limbo, often for more than a year,” said Nadeem Esmail, Fraser Institute director of health policy studies and co-author of the report, adding: “This raises important questions about whether the drug evaluation system in this country is beneficial or detrimental to Canadians.”