Regulatory Focus™ > News Articles > UPDATED: Report: FDA Quicker Than EMA, Health Canada for Drug Approvals

UPDATED: Report: FDA Quicker Than EMA, Health Canada for Drug Approvals

Posted 17 May 2012 | By Alexander Gaffney, RAC 

A study published in the New England Journal of Medicine (NEJM) claims the US Food and Drug Administration (FDA) is better at approving drugs than the European Medicines Agency (EMA) and Health Canada.

The study, conducted by a team of researchers from Yale University, shows FDA to have approved more drugs and in less time on average, with products arriving to US markets before European and Canadian markets in the majority of cases.

Between 2001 and 2010, FDA approved 225 new drugs, with each product taking an average of 303 days to approve. Meanwhile, EMA and Health Canada respectively approved just 186 and 99 drugs during that time, taking on average 366 days (EMA) and 352 days (Health Canada) to review the drugs.

The quicker review times in the US comes despite many products requiring multiple reviews, noted the study.

The US regulator also beat EMA and Health Canada in getting products to market before other countries.

"Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the US and in Europe were approved for US patients first, and 86% of medicines approved in both the US and Canada were also approved first in the US" said Nicholas Downing, a medical student at the Yale School of Medicine and lead author of the study.

[Editor's note: a previous version of this story used incorrect numbers for FDA and Health Canada's mean approval times.]


Read more:

NEJM - Regulatory Review of Novel Therapeutics - Comparison of Three Regulatory Agencies

Yale - In drug-approval race, US FDA ahead of Canada, Europe

Washington Post - Researchers say the FDA has approved more innovative drugs faster than EU and Canada

Med Page Today - FDA Gets Good Marks on Speed of Approvals

Pharmalot - FDA Reviews Drugs Quite Quickly, Thank You

BioCentury - Study shows FDA faster at reviews than EMA, Health Canada

MedIndia - US FDA Ahead Of Canada, Europe In Drug-approval Race


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