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Regulatory Focus™ > News Articles > The Canadian Special Access Program

The Canadian Special Access Program

Posted 01 January 2010

In Canada, the marketing of drugs and medical devices requires prior approval by Health Canada, the government department roughly equivalent to the US Department of Health & Human Services. Through a narrow, requestbased regulatory exemption called the Special Access Program, Canadian doctors (and patients) can gain access to otherwise unauthorized drugs and medical devices. This article explains this regulatory mechanism and the procedures involved.

 

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