Comparing FDA and EMA on new drug approvals

NDA Group announced findings from its fourth annual comparison of drug approvals in the European Union and the USA, ahead of this year’s DIA EuroMeeting in Glasgow, Scotland.

This year’s Status of New Drug Approvals report emphasizes the need for a streamlined global development and commercialisation process across the world’s two biggest markets.

The report – based on preliminary research figures from the European Medicines Agency and Food and Drug Administration websites in January 2017 – found that there has been a drop in US approvals but not in EU. For 2016 there were 74 new drug approvals granted in the USA and EU. Of these new products, 19 were approved only in the EU, 19 only in the USA, and 36 were granted in both regions. However, 17 drugs that were approved in the EU in 2016 had received prior approval in 2015 or earlier in the USA, while only six products registered in the US in 2016 were previously approved in the EU.