ABSTRACT

Since 2003, Health Canada has been undergoing regulatory modernization to "ensure that Canadians have faster access to the safe drugs they need", and national health agencies have developed policies to modernize the regulation of new drugs. We examined a decade of drug approval data from the Canadian setting to determine whether these policies promote innovation while maintaining safety. The drug approval data in Health Canada's Annual Drug Submission reports between 2000 and 2010 were analyzed to determine the proportion of new active substances qualifying as innovative new drugs. We also examined the proportion of successful submissions granted priority review that subsequently received safety warnings. We show that despite an increase in supplementary product submissions, there was no sustained increase in new active pharmaceutical or biologic products. Furthermore, priority reviews are intended to expedite new drug submissions that promise significant clinical benefits. While the proportion of submissions indicated for new active substances declined, there was a significantly higher rate of safety warnings for their priority reviews. Our results challenge the assumption that the new regulatory policies that were intended to spur industry innovation of new and safer drugs work.