Editor's Choice
Main Category: Regulatory Affairs / Drug Approvals
Article Date: 18 May 2012 - 14:00 PDT
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Healthcare Prof: Although the drug approval process in the U.S. has been perceived as too slow, the nation approves new drug treatments faster and earlier than Europe and Canada, according to researchers at Yale School of Medicine.
The study, conducted by Nicholas Downing, a second-year medical student and Joseph S. Ross, M.D., assistant professor of internal medicine at Yale School of Medicine, found that the median total time to review was:
- 322 days at The U.S. Food and Drug Administration (FDA)
- 366 days at The European Medicine Agency (EMA)
- 393 days at Health Canada
Downing explained:
"The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications."
The researchers reviewed drug approval decisions of the FDA, EMA, and Health Canada between 2001 and 2010 in order to determine the time it took to review novel therapeutics and timing of key regulatory events. The team selected Europe and Canada as a comparison due to the fact that they face similar pressures to approve new therapies quickly while ensuring drug safety.
Downing 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."
Downing continued:
"Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86% of medicines approved in both the U.S. and Canada were also approved first in the U.S."
Written By Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
- Additional
- References
- Citations
Nicholas S. Downing, A.B., Jenerius A. Aminawung, M.D., M.P.H., Nilay D. Shah, Ph.D., Joel B. Braunstein, M.D., M.B.A., Harlan M. Krumholz, M.D., and Joseph S. Ross, M.D., M.H.S.
New England Journal Of Medicine, May 2012, doi: 10.1056/NEJMsa1200223 Please use one of the following formats to cite this article in your essay, paper or report:
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