European Patients’ Academy on Therapeutic Innovation Aspects of pharmacovigilance: Periodic Safety Update Reports (PSURs)

European Patients’ Academy on Therapeutic Innovation  PSURs are pharmacovigilance documents intended to provide an evaluation of the benefit-risk balance of a medicinal product for submission by a Market Authorisation Holder (MAH) at defined points of time during the post-authorisation phase.  The European Medicines Agency maintains a list of EU reference dates (EURDs) and frequency of submission of PSURs for active substances contained in medicines in the EU. 2 What are Periodic Safety Update Reports (PSURs)?

European Patients’ Academy on Therapeutic Innovation  The EMA carries out single assessments of related PSURs for medicines containing the same active substances or combinations of active substances.  Single assessments occur even though the active substances in question may be contained in medicines subject to different marketing authorisations or authorised in more than one Member State.  The single assessment process aims to harmonise and strengthen the safety and benefit-risk review of medicines across the European Economic Area. 3 Assessment of the PSUR

European Patients’ Academy on Therapeutic Innovation  The main objective of the PSUR is to present a comprehensive, concise, and critical analysis of the benefit-risk balance of the medicinal product, taking into account new or emerging information in the context of cumulative information on benefit-risk in the post- marketing environment 4 Scope of the PSUR

European Patients’ Academy on Therapeutic Innovation  European Medicines Agency (2013). EMA/816292/2011 Rev 1. Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report. Retrieved 29 September, 2015, from y/Scientific_guideline/2013/04/WC pdf y/Scientific_guideline/2013/04/WC pdf 5 Further reading