Understanding Periodic Safety Update Reports (PSURs) in Pharmacovigilance
Periodic Safety Update Reports (PSURs) are essential pharmacovigilance documents that evaluate the benefit-risk balance of medicinal products post-authorization. These reports are submitted by Market Authorization Holders (MAH) at specified intervals to ensure the ongoing safety and efficacy of medicines in the European Economic Area. The European Medicines Agency (EMA) conducts single assessments of related PSURs to harmonize safety and benefit-risk reviews across member states. The primary objective of PSURs is to provide a comprehensive analysis of the benefit-risk profile by considering new and cumulative information in the post-marketing environment.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
European Patients Academy on Therapeutic Innovation Aspects of pharmacovigilance: Periodic Safety Update Reports (PSURs)
What are 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
Assessment of the PSUR 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
Scope 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
Further reading 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 http://www.ema.europa.eu/docs/en_GB/document_librar y/Scientific_guideline/2013/04/WC500142468.pdf 5
