Aspects of pharmacovigilance: Periodic Safety Update Reports (PSURs)

1. Aspects of pharmacovigilance: Periodic Safety Update Reports (PSURs)

2. What are Periodic Safety Update Reports (PSURs)? • 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.

3. Assessment of the PSUR • 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.

4. Scope of the PSUR • 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

5. Further reading • 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 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf