FDA and EMA on the Same Page for Most Drug Approval Decisions, Analysis Shows
A study by the FDA and EMA comparing their decisions on drug marketing applications found the two agencies align in most cases — but sometimes reach different conclusions about a drug’s efficacy.
Led by researchers from CDER, the FDA’s Office of Global Policy and Strategy and the EMA’s Human Medicines Evaluation Division (HMED), the analysis compared 107 new drug applications the two agencies made decisions on between 2014 and 2016.
The agencies agreed on marketing authorizations up to 98 percent of the time, the study found. The EMA had a higher rate of first-cycle approvals than FDA, the researchers found. For applications submitted first to the FDA, it was “not uncommon for data in the EMA submissions to be more mature, including trials that were ongoing at the time of submission to FDA,” the study found.