A review of the time taken by the Food and Drug Administration (FDA) in USA and the European Medicines Agency (EMA) in Europe to assess applications for new medicines over a 5 year period revealed that the FDA takes on average 60 days less to approve an application.
The review covered the 170 approvals by FDA and 144 approvals by EMA for new drugs over the period 2011 to 2015. Overall, the FDA took an average of 306 days compared to the EMA’s 383 days.
In terms of therapeutic areas, the FDA was faster for cancer and hematologic disease and for infectious disease, whilst the EMA was faster for other therapeutic areas. Both agencies took a similar amount of time to review applications for drugs to treat cardiovascular disease.
Of the 142 therapeutic agents approved by both agencies, FDA were quicker, taking 303 days compared with 369 by EMA.
Interestingly, of those medicines with orphan status the FDA approved nearly half (43.5%) whilst EMA approved a quarter (25.5%).
The results show a similar pattern to 2001 to 2010 levels.
To see the results of the review in full, please visit the NEJM website.