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Yale research: New Drugs Are Approved Faster in US Than Europe And Canada

HealthDay reports that the findings counter a common belief that the drug-approval process by the U.S. Food and Drug Administration is especially slow, according to Yale University School of Medicine researchers.

The study authors reviewed drug-approval decisions made between 2001 and 2010 by the FDA, Health Canada (the Canadian drug regulator), and the European Medicines Agency (EMA). The latter agencies were chosen for comparison with the FDA because they face similar pressures to approve new drugs quickly while ensuring patient safety.

Study leader Nicholas Downing, a second-year medical student, said:

“Among the subsample of drugs approved for all three regulators, the FDA’s reviews were over three months faster than those of the EMA or Health Canada.

The total review time at the FDA was faster than EMA, despite the FDA’s far higher proportion of applications requiring multiple regulatory reviews.

Examining novel drugs approved in multiple markets, we found that 64 percent of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86 percent of medicines approved in both the U.S. and Canada were also approved first in the U.S.”

Read here how the FDA approves drugs.