Report: Patient safety is not compromised with faster EU regulatory process

AdvaMed-Sponsored Report Says Safety Not Improved By Longer Approval Process (WSJ)

A new report prepared by the Boston Consulting Group shows that a slower regulatory process in the U.S. doesn’t improve the safety of patients here compared to Europe. Findings show that the number of products pulled due to “significant health risks” is about the same in the U.S. as in Europe, at about 21 per year. “The therapeutic mix and type of recall is also similar to that in the U.S.,” the report says.