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On October 3, 2012, Health Canada issued a press release announcing that it will develop a framework for the marketing approval of drugs to treat rare life-threatening, seriously debilitating or serious chronic rare diseases that are commonly referred to as "orphan drugs."
In a recent decision of the Federal Court in Hospira Healthcare Corporation v. Canada (Attorney General) the Court affirmed that Health Canada has broad discretion in interpreting the Food and Drug Regulations to determine the content of an application for the marketing approval of a drug
