Canadian, European and United States new drug approval times now relatively similar

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Abstract

The objectives of this analysis were to assess whether consistency in Health Canada's (HC's) approval times identified in 2011 has been sustained and to compare HC's approval times with those of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Between 2002 and 2016, 460 new drugs were approved by at least one of the agencies: 351 (76.3%), 319 (69.3%) and 392 (85.2%) by HC, the EMA and the FDA, respectively – all three approved 252 (54.8%). Overall medians and inter-quartile ranges of approval times for HC, the EMA and the FDA were 364 days (343–651), 371 days (322–434) and 304 days (209–455), respectively. The EMA's annual median approval time was consistent over the 15 years, while HC's and the FDA's median times were only consistent with each other and the EMA after 2005. Almost 80% of the drugs approved by all three agencies were submitted to HC later than to the other two agencies, which led to a median delay of a year between the agency first giving approval (FDA or EMA) and HC's approval. Rates of drugs withdrawn for safety reasons were 1.4% in Canada, 0.9% in Europe and 0.8% in the United States.

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