EMA's PSUR hub brings together the operational framework for periodic safety update reporting in the EU.
Official resource
What the hub covers
The page explains submission requirements, the relationship with the EU reference dates (EURD) list, the PSUR single-assessment (PSUSA) procedure, assessment guidance and post-authorisation procedural questions and answers.
Practical use
Use this resource when determining whether and when a PSUR is due, how the report should be submitted, how PSUSA applies, and how an assessment outcome should be implemented.
The format and substantive content of the report are governed by applicable EU legislation and GVP Module VII. EMA procedural advice explains how those requirements are handled in practice and should therefore be read alongside the EURD list and the PSUR Repository resources.