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EMA lags behind FDA for drug reviews

Drugs reviewed more rapidly and reach market more quickly in US than in Europe says NEJM study

European regulators are slower to review new drugs than their US counterparts according to a new study.

The report, published in the New England Journal of Medicine (NEJM), said the US Food and Drug Administration (FDA) is, on average, able to complete its review process for a new drug 44 days before the European Medicines Agency (EMA).

Researchers also found that between 2001 and 2010, of the 225 drug applications approved by the FDA, the agency recorded a median review time of 322 days per drug, compared to 366 days for the EMA, which processed 186 applications.

However, the study found the EMA's review process was quicker than Canada's drug body, Health Canada, which recorded a median time of 393 days for its 99 applications.

Among the 72 products approved by all three regulatory agencies, the median total review was again lower for the FDA at 268 days, compared to 356 days at the EMA and 366 days at Health Canada.

In addition to this swifter review process, the US also had a superior proportion of novel therapeutics first approved in the region, with 63.7 per cent of the 190 drugs approved by both the FDA and the EMA receiving their first approval in the US. These drugs were also available to patients a median of 96 days earlier in the US.

Similarly, among the 154 products approved in the US and Canada, 85.7 per cent were first approved in the US, with the drugs available a median of 355 days ahead of Canada.

“[T]he FDA reviewed applications more quickly, on average, than did the EMA and Health Canada, and the vast majority of these novel therapeutics were first approved for use in the US,” said the report, which was authored by a team from Yale University using freely accessible information from each agency.

“Our findings contradict recent criticisms of the speed of review by the FDA and lead to questions about whether the speed of the review process is justified as an emphasis for Prescription Drug User Fee Act (PDUFA) V, particularly since the FDA continues to outpace its European and Canadian peers.”

The PDUFA, which was introduced in 1992, is a law to allow the FDA to collect fees from drug manufacturers to fund the drug review process in exchange for adhering to performance standards.

It is subject to reauthorisation every five years, with PDUFA V due to be written during 2012, and drug approval times is an issue that many in the pharma industry are keen to see addressed.

However, the knowledge that the FDA is faster than both the EMA and Health Canada in this process may change the debate, according to Allan Coukell, director of medical programmes for the Pew Health Group, which funded the research.

He said: “[T]his paper indicates that the agency - at least at one key point along the regulatory pathway - is moving faster than its peers. This should instill greater confidence among drug makers, doctors, and patients in our government's ability to efficiently oversee new drug development.”

18th May 2012

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