Regulatory decisions in US and EU align

Country

Netherlands

Over the past decade, the European Medicines Agency and the US Food and Drug Administration have stepped up their collaborations with the result that more than 90% of the marketing authorisation decisions made by the two organisations are aligned. This is the conclusion of an analysis conducted by the EMA and FDA, which compared outcomes on 107 new medicine applications between 2014 and 2016. While both agencies evaluate applications independently, they nevertheless are coming to many of the same conclusions.