Comparison shows drop in FDA approvals but not in EU

An annual comparison of drug approvals in Europe and the US, performed by NDA Group, has found that there has been a drop in drug approvals in the US but not in the EU. These findings emphasise the need for streamlined global development and commercialisation process across the world’s two biggest markets.

“Understanding the evolving regulatory landscape and requirements is a key concern for the drug developing industry, as it is for us at NDA,” said Johan Strömquist, CEO of NDA Group. “It is intriguing to see how expedited pathways shape this year’s statistics just like it did last year, but with a very different outcome. It is also interesting to see the continued rise of smaller companies in the percentage of products taken to market.”

The report, based on preliminary research figures from the EMA and FDA websites in January 2017, showed that in 2016 there were 74 new drug approvals granted in the US and EU. Of these new products, 19 were approved in the EU only, 19 in the US only and 36 were granted in both regions.

“The findings show that the FDA has had a significant drop in drug approvals but continues to grant more expedited and nonstandard review approval status than the EMA,” added Terese Johansson, PhD, NDA’s consultant behind the research. “The drop is not as pronounced in the EU but is likely to be more prominent in 2017. Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common.

“This report also highlights the continued trend that many companies first seek approval in the US. Both EU and US show increases in drug approvals from small and medium sized pharma but big pharma still dominates the drug approval statistics,” she continued. “The biggest therapeutic area was oncology.”