FDA approves drugs three to four months faster than the EMA

Office of the US Food and Drug Administration

The United States medicines safety watchdog approves more new drugs and is faster than its peer agency in Europe, according to the results of a study published in the New England Journal of Medicine (online, 5 April 2017)[1]

Researchers found that the US Food and Drug Administration (FDA) gave the green light to 170 new drugs between 2011 and 2015, compared with 144 approved by the European Medicines Agency (EMA) in the same period. 

The median time it took for a drug to gain FDA approval during this time was 306 days, the researchers found, compared with 383 days for a drug to complete the EMA system.

New drugs for cancer and blood diseases were singled out by the authors as moving through the FDA system especially quickly, taking a median of 206 days compared to 379 days in Europe.

On the whole, the research shows that the FDA is working around three to four months faster than its European peer agency, confirming that the US agency has upped its pace in recent years.

A separate paper published in 2012 compared the time the FDA took to approve new drugs between 2001 and 2010 compared with the EMA as well as the Canadian drugs safety watchdog, Health Canada.

These results, also published in the New England Journal of Medicine (online, 14 June 2012)[2]
, revealed that the FDA was working around two to three months faster than the two other agencies.

The latest research comes at a time when the FDA’s drug approval system is being scrutinised as part of a government review of the US Prescription Drug User Fee Act — the law that determines the agency’s funding.


[1] Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015. New England Journal of Medicine 2017. doi: 10.1056/NEJMc1700103

[2] Downing NS, Aminawung JA, Shah ND et al. Regulatory review of novel therapeutics — comparison of three regulatory agencies. New England Journal of Medicine 2012. doi: 10.1056/NEJMsa1200223

Last updated
The Pharmaceutical Journal, April 2017;Online:DOI:10.1211/PJ.2017.20202570