Monday, March 12, 2007

Changes mulled in licensing medicines

From the Globe and Mail:
Health Canada is considering changing its system of licensing prescription drugs, moving to one where the safety and effectiveness of medicines would be more closely monitored after products are approved for sale.

A discussion paper proposes progressive licensing for drugs to follow up on them once large numbers of people are taking them. Clinical trials used to bring drugs to market are typically small; rare side effects generally come to light only when medications are taken by many thousands of people.

The aim is to improve the capacity of the regulatory system to monitor the safety of medication during the life cycle of a drug. The importance of this has been underscored in recent years by the revelation that popular painkillers from the cox-2 inhibitor family raised risks of heart attack and stroke. ...more

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