Thursday, October 29, 2009

The road to roll-out

From CBC News:
It's normally a complicated and lengthy process to get new drugs approved in Canada. After years of research and development, a drug company is required to conduct extensive clinical trials to back up its claims that the drug will work the way the company says it's supposed to, before it can submit it for approval.

Once the data's in, the company has to assemble the appropriate paperwork — the New Drug Submission — and ship it off to Health Canada's Therapeutic Products Directorate branch. If everything's in order, and Health Canada's satisfied that the drug's benefits will far outweigh its risks, it takes an average of 18 months for approval to come through.

It helps if the drug has already been approved in the United States.

That's the story for virtually all drugs — including vaccines. Yet it took only a few months for Health Canada to give the go ahead to Arepranix H1N1. That's the vaccine GlaxoSmithKline has developed exclusively in the Canadian fight against the swine flu pandemic. ...more

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