Canadian Approval Pathway Created for Extraordinary-Use New Drugs

Health Canada has amended the Food and Drug Regulations (Amended Regulations) to create a regulatory approval pathway for “extraordinary use new drugs” (EUNDs), which are drugs for emergency use in the prophylaxis or treatment of life-threatening or other serious diseases or conditions, caused by exposure to chemical, biological, radiological or nuclear substances. The amendments came into force on March 25, 2011. Previously, EUNDs were typically approved under the Special Access Programme. Under the Amended Regulations, a sponsor may file an EUND submission if it can establish that the drug is an EUND and that the regulatory safety requirements cannot be met because testing in humans would be potentially lethal or permanently disabling, and the circumstances in which exposure occurs is sporadic and infrequent. An EUND submission will have a reduced safety data package, by which safety is supported by in vitro or animal studies, the drug’s mechanism of action and pharmacokinetic and pharmacodynamic profile, and detailed post-marketing surveillance plans. All other regulatory requirements must be met in an EUND submission, including the provision of complete chemistry and manufacturing information. An EUND approved through this pathway can only be sold to federal, provincial, territorial and municipal governments. The Amended Regulations allow generic manufacturers to file abbreviated EUSD submissions referencing approved EUNDs. The Regulations and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) were amended to clarify that the Data Protection provisions of the Regulations and the PM(NOC) Regulations apply to EUNDs. For the text of the Regulations Amending the Food and Drug Regulations (1319 — New Drugs for Extraordinary Use), visit: http://tinyurl.com/6xbla64 Summary by: Michael Migus