Periodic safety update reports - European Medicines Agency (EMA)
Nov 26, 2025 · This page includes information on periodic safety update reports (PSURs), PSUR submission requirements, PSUR single assessment procedures (PSUSAs) and the European …
PSUR: Periodic Safety Update Reports, Your Full Guide | RegDesk
Oct 21, 2025 · What is a PSUR in medical devices? PSUR is an acronym for Periodic Safety Update Reports. In the medical device context a PSUR is a comprehensive report that …
Periodic Safety Update Reports (PSURs) in Pharmacovigilance: A …
Dec 21, 2025 · A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an evaluation of a drug’s benefit-risk balance at defined intervals post …
Periodic Summary Update Report (PSUR) & Post-Market …
Jan 22, 2025 · The PSUR is for higher-classification devices and is more detailed and comprehensive than a Post Market Surveillance Report (PMSR), but both are part of the …
ICH Guidelines for Periodic Safety Update Reports (PSUR): Key ...
Stay compliant with ICH guidelines for Periodic Safety Update Reports (PSUR) with key insights on regulatory requirements and safety reporting practices.
PSUR, PBRER, and DSUR Explained: Ultimate Guide to Global ...
Dec 18, 2025 · Three main report types dominate global regulatory submissions: the Periodic Safety Update Report (PSUR), the Periodic Benefit-Risk Evaluation Report (PBRER), and the …
Periodic safety update reports (PSUR) - CBG/MEB
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities …
PSUR Explained: Everything You Need to Know About Periodic
Apr 9, 2023 · A PSUR is a report that provides a detailed evaluation of the safety and efficacy of a medicinal product. It is a requirement for all medicinal products authorized in the European …
What Is A Periodic Safety Update Report (PSUR)? - Freyr Solutions
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.
Creating a Periodic Safety Update Report (PSUR) that Complies …
Feb 1, 2023 · The Periodic Safety Update Report (PSUR) is one of the new postmarket surveillance (PMS) activities required by EU MDR and EU IVDR. These new regulations …