This report evaluates approvals by the US Food and Drug Administration (FDA) utilizing data from FDA databases as well as BioMedTracker regulatory data. Additionally, this update looks at analyses of the European Medicines Agency (EMA) approvals utilizing their Agency database and annual reports, as well as BioMedTracker regulatory data. This report aims to detail approval trends for both agencies independently, as well as comparing drug review timelines between FDA and EMA to determine which region is approving drugs faster and putting drugs on the market first.

Key Points

• In a direct comparison of drugs which were approved in the U.S. and EU, the average time to approval was relatively similar while the median time to approval in the U.S. was ~5 months faster
• If approved on a first review in the U.S., the FDA drug approval process is faster than the EMA, but substantially slower if the drug is approved after the first review cycle
• Per the FDA, there were 97 New Drug Approvals (NDA) in the United States in 2013
• Year-over-year, the indications with the most approvals in the U.S. continue to be infectious disease and oncology with 22 and 23, respectively, in 2013
• For each review cycle, the FDA review process slowed in FY2013 vs. FY2012

For the full report, please download the PDF version at the top of this page.

For our disclosures, please read the BioMedTracker Research Standards.