EATG » US drugs regulatory process faster than European agency’s

US drugs regulatory process faster than European agency’s

The US regulator, the Food and Drug Administration (FDA) reaches its decisions more quickly than its European counterpart, the European Medicines Agency (EMA), finds an analysis* published in a letter in the New England Journal of Medicine.

On average, the US speed of regulatory review for new medicines was around 60 days faster, the findings suggest.

The researchers compared the total number of days taken by the FDA and the EMA to reach a decision on whether to approve or not between 2011 and 2015.

All the new drugs approved during this period were grouped by therapeutic area and orphan status.

Between 2011 and 2015, the FDA approved 170 new drugs while the EMA approved 144. The therapeutic areas for the approvals were similar in both agencies, although the FDA approved more medicines designated as orphan drugs than the EMA — 43.5% compared with 25% of the total.

The average length of time it took the FDA to reach a decision was 306 days compared with 383 days for the EMA.

The total review times were shorter at the FDA than at the EMA for medicines that are used for the treatment of cancer and blood disorders, but not for other therapeutic areas, and for medicines designated as orphan drugs.

Among the 142 drugs that were approved by both the FDA and the EMA, the average total review time was 303 days at the FDA, compared with 369 days at the EMA.

For new drugs approved between 2011 and 2015, the regulatory reviews by the FDA were, on average, 60 days shorter than those by the EMA.

But preliminary figures** issued by global drug development consultancy the NDA Group last month found that the number of approvals for new drugs by the FDA fell in 2016.

Last year, both agencies approved 74 new drugs, of which 19 were approved only in the US, and 19 only in the EU; 36 were given the green light in both regions.

But 17 drugs approved in the EU in 2016 had received prior approval in 2015 or earlier in the US, while only six products registered in the US in 2016 had been granted prior approval in the EU.

Terese Johansson, who led the NDA analysis, commented: “The findings show that FDA has had a significant drop in drug approvals but continues to grant more expedited and non-standard review approval status than the EMA.”

She added: The drop is not as pronounced in the EU but is likely to be more prominent in 2017. Expedited drug development and non-standard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common.

* Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015. N Engl J Med 2017; 376:1386-1387, April 2017. DOI: 10.1056/NEJMc1700103

** Johansson T. Europe vs USA: new drug product approvals in 2016. NDA Group.

News categories: EMA/FDA