In a study recently published by the New England Journal of Medicine, two researchers from the Yale School of Medicine studied the average time from clinical trial to approval by the FDA in the U.S., the European Medical Agency (EMA), and Health Canada between 2001 and 2010.
Although the average approval time still may seem long, the FDA approval time was more than two months faster than the EMA and more than three months faster than Health Canada.
Average drug approval times:
FDA 322 days
EMA 366 days
Health Canada 393 days
Approval agencies around the world are always under pressure to approve potentially successful drugs as soon as possible and many approvals are done in less time than the averages shown here. It is worth noting also that a long approval time may mean that the study results are not as clear cut as it seems and the FDA needs to ask more questions. The other side of the coin, of course, is when a drug may be approved too quickly and then have to be recalled because of risks and problems not known at the time of approval.
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(c) 2012 Tom Beer and Larry Axmaker