Health Canada proposes new regulatory regime for drugs

Kondro, Wayne
April 2007
CMAJ: Canadian Medical Association Journal;4/24/2007, Vol. 176 Issue 9, p1261
Academic Journal
The article reports that Health Canada is proposing a new regulatory regime for pharmaceuticals and biologics. The proposition was to support its move to lower the threshold for initial market authorization licenses in exchange for additional safety and efficacy studies as the condition for selling drug. The regulatory regime incorporates the notion of post-market surveillance into Health Canada. Nevertheless, the changes that the proposed regime offers are still being reviewed.


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