A Periodic Safety Update Report (PSUR) is a structured pharmacovigilance document that summarizes cumulative safety data for a medicinal product over a defined reporting interval.
PSURs evaluate worldwide adverse event reports, emerging safety signals, exposure estimates, and benefitñrisk balance to determine whether new risk controls are needed. They often include analyses of special populations, medication errors, and post-authorization study updates where applicable. Regulators use PSURs to assess whether labeling changes, additional monitoring, or risk minimization actions are warranted. For sponsors, high-quality PSURs demonstrate mature safety surveillance and support consistent global safety governance.