US Drug Approvals Top Canada, Europe

The FDA approves drugs faster and earlier than regulatory agencies in other countries.

By | May 18, 2012


Despite the seemingly slow pace of the US Food and Drug Administration (FDA) drug approval process, the agency actually approves drugs faster and earlier than regulators in Canada and Europe, according to a review of a decade of drug approvals published online May 16 in the New England Journal of Medicine.

Researchers at Yale University School of Medicine found that for drugs approved between 2001 and 2010, the median total time of FDA review was 322 days, compared to 366 days at the European Medicines Agency (EMA) and 393 days at 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,” study author Nicholas Downing said in a press release.

In total, 510 drug applications were approved by the 3 agencies in those 10 years: 225 by the FDA, 186 by the EMA, and 99 by Health Canada. And many therapies were first approved for use in the U.S., the authors found: about 64 percent of therapies approved in both the U.S. and in Europe, and 86 percent of those approved in both the U.S. and Canada, received their US approval first.

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Avatar of: Anne Breen

Anne Breen

Posts: 1457

May 18, 2012

And what are the corresponding rates of actual drug recalls in these countries.  and what about impact of political or religious influences pro or con?  I am trying to get my message through and still waiting for a safe old generic anti-progesterone drug,  the French morning after pill approved in Europe a long time ago for other female conditions like uterine fibroids, meningioma and ovarian cancer. HELP! GBYAY Anne Breen you can visit my blog at     

Avatar of: Echohawk


Posts: 4

May 19, 2012

Recently I have been noticing an increase of drugs being heavily marketed on prime time  TV, and quite often you will see about 18 to 24 months later a law firm on the same TV time slot advertising they have a class action law suit on the maker of that drug, due to serious harm and/or death related to the use of that very same drug .
Is there a direct correlation of this perceived increase of harmful drugs that get marketed , due to the FDA's streamlining of their approval system ?
Or is it more of a numbers game where certain percentage of drugs that get approved will in fact do more harm than good ?

Avatar of: Anne Breen

Anne Breen

Posts: 1457

May 20, 2012

We need to stand together to make sure there is free public access to all for all federal government medical clinical trials funded by our tax payer money, including knowledge gained from the unpublished ones too.

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