Drug approvals in EU and US for SMEs exceed big pharma in 2017

Posted on 17/05/2018

Small and medium-sized enterprises (SMEs) have surpassed big pharma for the first time in their share of drug approvals in the EU and US.

Extracting data from the European Medicines Agency and US FDA websites, consulting group NDA found that SMEs were responsible for 51% of new drug approvals in 2017, compared with 49% from big pharma1. This was an increase from previous years of 47% in 2016 and 28% in 2015 for SMEs. In the past few years big pharma’s share of new drug approvals has been on the decline (53% in 2016, 72% in 2015 and 64% in 2014).

Overall, in 2017, drug approvals increased in the EU and the US compared with 2016 figures1. There was a total of 103 drug approvals in the EU and US (compared with 74 drug approvals in 2016 and 89 in 2015). Of these, 36 applications were granted in both regions, 15 were approved in only in the EU and 52 only in the US. Drugs which were classified as novel made up more than half of total approvals (n=56, 54%). In 2016, of the total number of drug approvals in the EU and US (n=74), 35 were classified as novel drugs (47%).

This success is even more prominent considering SMEs face many regulatory challenges specific to small and start-up companies.

Lynda Wight, Executive Director of TOPRA, said: “These data demonstrate the importance of SMEs in delivering innovation and they need support to enable them to maximise their regulatory effectiveness. TOPRA’s dedicated SME stream at the 2018 Annual Symposium will give such companies an opportunity to access the information, contacts and support they need.”



  1. T Johansson. Europe vs USA: new drug product approvals in 2017. 11 April 2018. Available at: http://www.ndareg.com/europe-vs-usa-new-drug-product-approvals-in-2017/ (accessed 4 May 2018).