FDA fastest in granting new drug approvals among major regulators including EMA, TGA, Health Canada

Monday, February 2, 2015

FDA fastest in granting new drug approvals among major regulators including EMA, TGA, Health Canada

Among six major regulatory agencies worldwide, the FDA has emerged as the fastest in approving new medi­cines.

A new report from the London-based Center for Innovation in Regulatory Science (CIRS) showed that for 2013, the FDA’s median approval time for new drugs was the lowest— at 304 days—compared to 478 days for the European Medicines Agency.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) was second lowest at 342 days, followed by Health Canada at 350. Australia’s Therapeutic Goods Admin­istration (TGA) took 391 days for approvals, placing the EMA fifth. SwissMedic—the smallest of the six—came in last with a median approval time of 511 days.

These approval times were part of a study of regulatory drug reviews over a 10-year period between 2004 and 2013. During that time, all six government agencies reduced the time needed to approve new medicines. Some were faster than others, according to CIRS’ report, The impact of the changing regulatory environ­ment on the approval of new medicines across six major authorities 2004-2013.

The underlying factors influencing the overall time it takes for a new medicine to be submitted and then approved by a regulatory authority includes company strategy, the conduct and type of review process and the type of product and therapeutic area, said CIRS.

“Noticeable variations still exist in the rela­tive efficiency of individual regulatory authori­ties in granting approvals in a timely manner, which may be largely a reflection of the differ­ences in processes employed by the authori­ties,” the report stated. Relative efficiencies were estimated using a cumulative percentage of approvals over a fixed period of time.

The study cited the accomplishments of Health Canada, which approved the highest number of new active substances (NAS) in a decade and the highest among all six agencies in 2013. However, Health Canada and the other smaller agencies had similar approval numbers, and many of the compounds they approved already had gained approval from the FDA in previous years.

Between 2011 and 2013, 20% of FDA ap­provals were granted within six months of sub­mission, “faster than for the other authorities, and which may show the role played by priority reviews in the U.S. system,” the report stated.

One reason the EMA had the lowest num­ber of expedited reviews is due largely to the European system, said Neil McAuslane, Ph.D., director of CIRS.

“Unlike Japan’s PMDA and the U.S. FDA , priority reviews are viewed very positively and carefully watched, while at the EMA, the review times are legislated and a bit higher—so they are different,” said McAuslane.

Median approval times between a chemical entity and a biological/biotechnology product were minimal across the FDA, EMA and PMDA. Health Canada’s chemical-based pharmaceu­ticals were approved 42 days faster, and Swiss­Medic’s were 14 days quicker, the study noted.

“Japan is a star in relation to our data, as it has worked very hard to develop priority systems since 2006,” said Magdalena Bujar, a research analyst and author of the report. “Its review times came down in 2007 and 2008, and it seemed to work harder in this most recent time period to improve the regulatory environment.”

Viewing the approvals based on therapeu­tic area, the study found between 2009 and 2013, nearly 30% of total approvals among the six agencies were anti-cancer and immuno­modulator drugs—the largest disease area, as companies are developing more compounds to address the high unmet medical need, the report stated. During that five-year period, the median approval times for those drugs were the fastest when compared with all other therapeutic areas. The FDA led the group with a median approval time of 240 days, followed by Heath Canada at 350 days and Japan’s PMDA at 365 days. The EMA, by contrast, had a median approval time of 450 days.

Noted Bujar, “The FDA seems to have the most flexibility in pathways for approval.”


Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 04, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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