Who is Faster in Approving: FDA or EMA; and Why Should it Matter  
​[Posted on: Thursday, April 13, 2017]

An analysis published in the New England Journal of Medicine last week, it was proven with data that overall FDA is much faster than its nearest peer, the European Medicines Agency (EMA) in approving new products. Over the last 5 years, FDA took almost half as long as EMA to approve anti-cancer products, and about two-thirds of the time to approve anti-infectious agents compared to EMA. On an average FDA takes about 20% less time that EMA to approve products. For most products other than anti-cancer, hematologic and anti-infective agents, FDA and EMA took almost similar times. The speed of approval of products by regulators may have an impact in political discussions but for practical purposes, a general number has limited benefit to the work horses in the industry. The rules for review have been harmonized significantly across FDA and EMA in the last 2 decades with both agencies following similar applications and review philosophies. However, FDA is a much larger organization with much larger resources so it may not be a fair comparison between the two agencies. Also, there are differences in the clinical and nonclinical studies required by the two agencies for a positive decision which could influence the overall approval time so just looking at the final market approval application review time may give a partial picture. From a strategic point of view, developers of anti-cancer and anti-infective products should certainly pursue FDA approval first. Overall, the strategic and business priorities of a given manufacturer will define which region they seek first approval. These days with parallel multi-region submissions, such comparisons satisfy academic curiosity but have limited practical benefit.