One of the findings of a joint European Medicines Agency (EMA) and Food and Drug Administration (FDA) analysis compared decisions on 107 new medicine applications at the two agencies for the period 2014 to 2016. The majority of the information used for the study was sourced from EMA’s publicly available European Public Assessment Reports (EPARs) and FDA reviews. In addition, the study assessed applications for which the EMA and FDA had different outcomes in relation to the type of approval and indication.
Reasons identified for diverging decisions at the two agencies were differences in conclusions regarding efficacy and differences in clinical data submitted in support of an application. Differences were identified in the clinical data due to the difference in timing of submissions, for example a greater number of applications were submitted to the FDA before they were submitted to the EMA.
In comparison to the FDA, the EMA regularly reviewed applications including additional clinical trials, or more mature data from the same clinical trial. In these situations, the EMA were more likely than the FDA to grant standard approval, a broader indication, or use of a medicine as first-line therapy.
The head of EMA’s human medicines evaluation division stated that “the high rate of convergence in the authorisation of new medicines at EMA and the FDA is the result of expanded investment in dialogue and cooperation since 2003 and has fostered alignment between the EU and the US with respect to decisions on marketing authorisations, while both agencies evaluate applications independently of each other”.
To read more on the EMA/FDA analysis which showed a high degree of alignment in marketing application decisions between the EU and US, please click here.