Periodic Safety Update Report(PSUR)

Periodic Safety Update Reports exist because a marketing authorisation is granted on trial data from a controlled population, while the safety profile that matters emerges later, in routine use, across markets the sponsor does not directly observe. PSURs force the marketing authorisation holder to stop at fixed points, aggregate what was learned worldwide in that window, and state in writing whether the benefit-risk balance still holds.

Periodic Safety Update Reports cover the cumulative and interval safety experience of an authorised medicine: exposure estimates, signals evaluated during the period, and the benefit-risk conclusion that follows. PSURs do not replace expedited reporting, so individual serious reactions still go in on their own clock. PSURs also stop at the authorisation boundary: safety data on a product still in clinical development belongs in a development safety report, not here.

Periodic Safety Update Reports run on an externally fixed calendar rather than the author's schedule. The EU reference dates list sets each active substance's data lock point and reporting interval and is legally binding, and the submission clock then runs 70 or 90 calendar days from that data lock point. PSURs are required for both centrally and nationally authorised medicines, whichever assessment route the product follows.

The obligations split by jurisdiction; these are the anchors a PSUR programme is audited against.