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  • September 24, 2019

AMSTERDAM, Netherlands—The European Medicines Agency (EMA) and the FDA agree on more than 90 percent of marketing authorization decisions for new medicines, according to a joint EMA/FDA analysis. The analysis compared the two agencies’ decisions on 107 new medicine applications from 2014 to 2016. In the 10 percent of cases where the agencies disagreed on an authorization decision, the cause was either differing conclusions on drug efficacy or differences in in the clinical data submitted. This is the first analysis by EMA and the FDA that compares the agencies’ decisions on marketing authorizations.