Regulatory Focus™ > News Articles > Updated: FDA and EMA in 2016: A Look at the Numbers

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Posted 19 January 2017 | By Michael Mezher 

Updated: FDA and EMA in 2016: A Look at the Numbers


The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended.

In fact, both regulators saw the lowest number of new drugs given a positive review in their respective jurisdictions in years. For EMA, the number represents the fewest NASs recommended in a single year since 2011; while FDA's Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, it's fewest since 2010.

EMA spokeswoman Rebecca Harding told Focus: "There are always ups and downs in approval numbers of new active substances and it is too early to establish whether this is a trend towards a decrease. In the past three years we have seen a positive trend in submissions of marketing authorisation applications (see our annual reports). 

"Looking at the medicines’ pipeline, the outlook does not suggest a trend towards declining numbers of applications for new active substances," she added. 

While the comparison isn't one to one—some products recommended by EMA, such as CLS Behring's recombinant blood products Afstyla and Idelvion, were approved by FDA's Center for Biologics Research and Evaluation (CBER)—the figures represent a shift from recent record-breaking approvals in both regions.

In 2015, EMA recommended a total of 39 new active substances, while CDER approved a record 45 new molecular entities.

FDA has in part explained the drop-off in approvals as a timing issue. In November, former director of FDA's Office of New Drugs John Jenkins explained that the agency had fewer applications to act on in 2016, in part due to a decline in the number of applications submitted, an uptick in complete response letters and the agency having approved five drugs with 2016 Prescription Drug User Fee Act (PDUFA) goal dates ahead of schedule.

Focus has reached out to EMA for an explanation on why the number of 2016 recommendations is down from a year earlier and will update this article accordingly.

For both regulators, the proportion of drugs r

eceiving orphan designation or benefiting from one of the regulators expedited pathways was similar to the previous year. In 2016, EMA recommended 10 products with orphan designation, compared to 18 in 2015, while CDER approved nine orphan drugs. It's worth noting that Idelvion, which appears on EMA's list of NASs, was also approved by CBER with orphan designation in the same year.

Notably, in 2016, EMA did not recommend any NASs "under exceptional circumstances," though eight of the 27 products EMA recommended were granted a conditional marketing authorization.

EMA also kept its lead in biosimilars, recommending seven biosimilars in 2016, compared to three biosimilars approved by FDA.

EMA and CDER 2016 Activities (NAS/NME)
RegulatorEMAFDA (CDER)
Orphan Designation10 (37%)9 (41%)
Expedited Pathway (EMA: Accelerated Assessment; FDA: Accelerated Approval, Breakthrough, Fast Track, Priority Review)4 (15%)16 (73%)

EMA – Human Medicines Highlights 2016

FDA – Novel Drugs Summary 2016

CBER - 2016 Biological License Application Approvals

Editor's note: This article was updated on 1/20 with comment from EMA.


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