Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.
Sharon C M EssinkInge M ZomerdijkSabine M J M StrausHelga GardarsdottirMarie Louise De BruinPublished in: Drug safety (2023)
The probability of completing an aRMM effectiveness evaluation at time for renewal of the MA was only one in five. Furthermore, estimates of the duration of studies around MA are too optimistic, with the majority being delayed.