Federal Delays in Approving New Medicines 2013

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This study measures delays in the approval of new medicines by Health Canada and provides patients with the information they need in order to determine whether the time they wait for access to new medicines in Canada is unnecessarily long.

Our findings reveal that Canadian approval delays are not insignificant. The most recent estimates calculated show that Health Canada took a median of 355 days to issue a notice of compliance for patented medicines in 2011?an improvement from the 448 days it took in 2010. Between 2007 and 2011, Canadians could generally expect a delay of nearly a year or more for access to new medicines after submission for approval. That delay was longer than experienced in Europe for most years during that period. It was also longer than experienced under the US FDA for between two and four of the five years studied.

While the requirement for governmental approval for sale is not unique to Canada, the process can add further delays for Canadians seeking treatment from these new medicines. An important question that arises from this comparison is the value of duplicating the application of safety standards between jurisdictions. Given the similarity of international safety standards and the relatively small size of the population served by Health Canada?s mandatory approval process, Canada?s federal government could improve access to new medicines through international harmonization and mutual recognition agreements.

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