The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.
Periodic Safety Update Report
Periodic Safety Update Reports are pharmacovigilance documents submitted to the Competent Authorities, which provide an evaluation of the risk benefit balance using the worldwide safety data collected in connection to a medicinal product. Marketing Authorization Holders and Competent Authorities use this evaluation to conclude on the safety and efficacy profile of the medicinal product and decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.
Periodic Safety Update Report in the European Union/EEA
In the EU/EEA, PSURs should follow a specific format (PBRER) and submission schedule.
The frequency with which the PSURs are to be submitted shall be specified in the marketing authorization. The dates of submission according to the specified frequency shall be calculated from the date of the authorization.
The Agency (European Medicines Agency) carries out single assessments of related PSURs (PSUSA) for medicines containing the same active substances or combinations of active substances in order to harmonize and strengthen the safety and benefit-risk review of medicines across the European Economic Area. Marketing authorization holders of branded products as well as generic products are expected to submit PSURs under this single assessments process, using the EURD list as reference for submission dates and DLPs (data lock points).