EMA Bests FDA in 2013 New Drug Approval Numbers

Posted 21 January 2014 | By Alexander Gaffney, RAC 

If regulation is a numbers game, the European Medicines Agency (EMA) may have just bested the US Food and Drug Administration (FDA) in 2013.

One of the best indications that a regulator is performing efficiently is the number of new molecular entities (NMEs) it approves in a given year. An NME is essentially an active substance that has never before been used for a given purpose, requiring new evidence of safety and efficacy. The thinking goes that a regulator that can approve more of these products in a given year is-assuming that safety issues do not emerge later on-serving patients by expediting access to new therapies.

While a myriad of factors can influence the approval of NMEs, including the quality of data submitted by industry and the number of applications submitted, regulators often highlight and brag about NME approvals in year-end reports.

FDA, for example, touted its approval of 27 NMEs in 2013 in a report last week. As explained in Focus, this number was somewhat disappointing given the 39 approvals seen in 2012, or 95% of all applications received. In contrast, 2013 had an approval percentage of just 75% (27 out of 36 applications).

EMA Data

EMA is now out with its year-end report on 2013 approvals, indicating a number of strong points of performance from the regulator.

EMA said it had recommended 81 medicines for marketing authorization in 2013, of which 38 contained a new active substance never before used in medicine. That number compared favorably with the 35 NMEs it approved in 2012, 25 in 2011 and 15 in 2010. In a statement, EMA said the number of NME approvals was "quite high."

The regulator also had some landmark approvals in 2013, such as the approval of the first two monoclonal-antibody biosimilars and two advanced therapy medicinal products (1) (2).

As with FDA, EMA said it had seen a favorable trend with new approvals in the rare disease space, with 11 of its 81 approvals affecting rare diseases, compared with just eight in 2012 and four in 2011. EMA also said it had seen success utilizing new expedited review pathways, such as its accelerated assessment and exceptional circumstances authorization procedures.

While it's difficult to compare the methodologies used by FDA and EMA, it would appear from data provided by both regulators that EMA edged out FDA in 2013 on NME approvals.

Still, FDA's report contains one piece of crucial data that EMA does not provide: first-in-world approvals. FDA approved 74% of its NMEs before any other regulator, it said in its report. Unless EMA approved substantially different NMEs than FDA, it would appear that FDA bested EMA in at least one metric.

EMA's report is available here.


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