PSURs try pharmacovigilance data meant to render an assessment of the risk-benefit equilibrium away from a therapeutic device at the discussed go out issues shortly after their authorisation.
The goal of this new PSUR is always to establish a thorough and you can crucial studies of your risk-benefit equilibrium of one’s tool, looking at this new or emerging shelter guidance on the framework off cumulative information about chance and you may positives
EMA and you can federal competent regulators determine information from inside the PSURs to choose if the you’ll find the latest threats identified to own a drugs and you will/or if perhaps the risk-benefit equilibrium changed. Continue reading “Submission standards and you may European union reference dates: the fresh new EURD number”