title: The timeliness of new drug approvals in Canada.
abstract: In a recent article, Lexchin asks "who needs faster drug approval times in Canada?" and, on the basis of extremely limited and selective data, draws the conclusion that neither the public nor the pharmaceutical industry does. Whether the Canadian system is really slower is investigated by comparing Canadian and U.S. marketing approval dates and by using information on regulatory approval times from the two countries and elsewhere. Marketing approval dates in Canada are significantly later than those in the United States, although not consistently across all therapeutic categories; anti-cancer and gastrointestinal drugs have earlier approval dates in Canada. However, Canadian and U.S. regulatory approval times are not significantly different, indicating that marketing applications are submitted later in Canada, but both are considerably longer than those in the United Kingdom. The evidence shows that Canadians need faster drug approval times if individuals requiring the medications are not to suffer unnecessarily. A significant decrease in drug approval times and the establishment of comprehensive and effective postmarketing surveillance would reduce the time it takes for new drugs to be made available to Canadians while, at the same time, providing a high level of drug safety.
authors.affiliation: Royal University Hospital, Saskatoon, Saskatchewan, Canada.
authors.forename: N S
authors.initials: NS
authors.lastname: Rawson
mesh_terms: D002170:Canada; D003431:Cross-Cultural Comparison; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D013997:Time Factors; D014481:United States