[co-author: Eftychia Sideri]

The European Medicines Agency (“EMA”) has released a guidance document for assessors. The guidance document is written in a questions-and-answers form. It should be read in combination with the explanatory note to GVP module VII.

The purpose of this document is to provide guidance concerning certain challenges related to the Periodic Safety Update Report (PSUR) single assessment (PSUSA) procedure. These challenges are specific to the EU single assessment of PSURs of medicinal products approved on national level. EMA has based this guidance document on the experience acquired from the PSUSA procedure since it started in January 2015.

The PSUR is a global document in which information such as product information, description of on-going procedures or risk minimisation activities should be provided. EMA’s guidance document provides that the purpose of the PSUR is to determine whether there are new risks or whether risks have changed and whether there are changes to the benefit/risk balance of the medicinal product. In addition, GVP module II describes the purpose of PSUR as presenting a comprehensive, concise and critical analysis of the benefit/risk balance of the medicinal product.

The guidance document highlights the aspects on which the review of the PSUR should focus and the strength and nature of the evidence required to support regulatory action. EMA underlines that any variation of marketing authorisation needs to be well justified especially if no differences in comparative incidence were found.

EMA also provides guidance concerning the link between PSUSA and the outcome of other regulatory procedures and concerning the scope of conclusions to be drawn regarding the impact on products outside the PSUSA.

The second part of the guidance document deals with specific assessment aspects of related sections of the PSUR AR template. Guidance is provided in relation to product information inconsistencies; exposure and safety data; safety specification/RMP inconsistencies; signals and issues under close monitoring; benefit risk evaluation; benefit risk balance; supplementary information within the next PSUR and PSUR frequency and EURD list.