VII.B.1. Objectives of the periodic update safety report (PSUR)

The main objective of a PSUR is to present a comprehensive, concise and critical analysis of the riskbenefit balance of the medicinal product taking into account new or emerging information in the context of cumulative information on risks and benefits. The PSUR is therefore a tool for postauthorisation evaluation at defined time points in the lifecycle of a product.

For the purposes of lifecycle benefit-risk management, it is necessary to continue evaluating the risks and benefits of a medicine in everyday medical practice and long term use in the post-authorisation phase. This may extend to evaluation of populations and endpoints that could not be investigated in the pre-authorisation clinical trials. A different risk-benefit balance may emerge as pharmacovigilance reveals further information about safety. The marketing authorisation holder should therefore reevaluate the risk-benefit balance of its own medicinal products in populations exposed. This structured evaluation should be undertaken in the context of ongoing pharmacovigilance (see Module XII) and risk management (see Module V) to facilitate optimisation of the risk-benefit balance through effective risk minimisation.

Urgent safety information should be reported through the appropriate mechanism. A PSUR is not intended, in the first instance, for notification of significant new safety or efficacy information or to provide the means by which new safety issues are detected, (see Module IX and XII). It is acknowledged that the review of the data in the PSUR may lead to new safety issues being identified.