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Regulatory Focus™ > News Articles > EMA Report: Approval Numbers Likely to be Lower than 2011

EMA Report: Approval Numbers Likely to be Lower than 2011

Posted 10 October 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has released a mid-year report detailing its progress in 2012, showing a projected decline in the number of submitted applications even as products seeking orphan designations surged 30%.

The report, highlighted in an EMA press release on 10 October, was originally reported to EMA's management board by Executive Director Guido Rasi.

Rasi, who took over EMA this year after Thomas Lonngren stepped down in the midst of controversy, has been making a series of transparency overhauls aimed at making the EU regulator more accountable. The report seems targeted at similar objectives, and outlines where EMA has made progress relative to 2011, and where it has the potential to miss its targets.

"Our main performance indicators have been met," said Rasi. "The mid-year report indicates that the Agency is on target to meet its core business objectives for 2012."

However, the report cautions that EMA may not be on pace to meet its objective for much longer, though not necessarily because of any action taken by regulators. "The forecast for applications to be submitted by the end of the year has been reduced from 112 to 101, owing mainly to a lower rate of submission of applications for generic medicinal products for human use than expected," it explained. Through the first half of 2012, EMA said it approved approximately the same number of applications as 2011-52-but did not specify the exact number.

The report also highlighted that more companies seem to be submitting requests for scientific advice and protocol assistance, perhaps as a result of new guidance aimed at clarifying the process of doing so for sponsors. From 2011 to 2012, requests for scientific advice increased 14% and requests for protocol assistance increased by 24%, "Confirming the growing importance for pharmaceutical companies to seek early advice from the Agency on their medicines-development programs," explained EMA.

Orphan drug applications for both human and animal species were both up considerably. Orphan drug applications were up a "significant" 30% over 2011, while veterinary minor use minor species (MUMS) classification requests were up more than 100% compared with 2011.

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