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PSURs are pharmacovigilance documents that evaluate the risk-benefit balance of medicines after authorisation. Learn how to prepare, submit and use PSURs in the EU, and access the EURD list and COVID-19 guidance.
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document which provides information related to the risk-benefit balance of a drug product post its authorization.
PSUR is a report that summarises the safety and benefit information of a medicinal product from clinical trials and post-marketing data sources. This guideline provides the principles, format and contents of PSURs for marketing authorisation holders in the EU.
Learn how to submit periodic safety update reports (PSURs) or periodic benefit risk evaluation reports (PBRERs) for approved medicinal products in the UK. Find out the submission dates, exemptions, fees and how to prepare your PSUR according to ICH and GVP guidelines.
This document provides guidance on the preparation and submission of Periodic Safety Update Reports (PSUR) for medicinal products in the EU. It covers the requirements, procedures, formats and timelines for PSUR according to Regulation (EU) 2017/745.
Learn how to use the ICH E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) instead of the U.S. periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR) to satisfy the postmarketing safety reporting requirements. This guidance applies to applicants with or without a PSUR waiver and provides the procedures, format, content, and timing of the PBRER.
Learn the differences and similarities between development safety update report (DSUR) and periodic safety update report (PSUR), two mandatory ICH regulatory documents for drug safety. Find out how to prepare and submit them according to national or regional requirements.
Learn about the post-market surveillance requirements for medical devices in the EU, including the Periodic Summary Update Report (PSUR) and the Post-Market Surveillance Report (PMSR). Find out the differences, frequencies, formats, and outputs of PSUR and PMSR for different device classes.
PSURs are reports that evaluate the safety and efficacy of medicinal products authorized in the EU. They are prepared by the MAHs and submitted to the EMA at predefined intervals. Learn how PSURs are prepared, what information they include, and why they are important.
PSUR is a report by the marketing-authorisation holder of a medicine describing its worldwide safety experience. Learn more about PSUR and its questions and answers on the EMA website.