Impact and Challenges of Periodic Safety Update Reporting
Year: 2025
Type: article
Abstract: This abstract explores the integral role of Periodic safety update reporting in the post-marketing surveillance process, highlights the challenges faced by marketing authorization holders in compiling and submitting these reports to Repository, and examines the harmonization of requirements across Europe Union. Pharmacovigilance has grown in breadth throughout time as a result of the realisation that a systematic strategy is necessary to monitor and improve the safe use of medications. Aggregate reporting plays a crucial role in assessing the benefit/risk ration of a medicinal product throughout its lifespan. It is frequently not enough for marketing authorisation holders to thoroughly evaluate the benefit/risk profile and obtain a complete understanding of the safety features of a pharmaceutical product. Therefore, periodic examination and analysis of cumulative safety data from several sources is required. The results are subsequently sent to regulatory bodies in the form of aggregate reports. Periodic Safety Update Reports playing a critical role in the ongoing assessment of medicinal products after they have been authorized for use. These reports are designed to provide regulatory authorities with a comprehensive, cumulative review of safety data, including adverse drug reactions, emerging safety signals, and evolving risk factors. This report contributes significantly to ensuring patient safety and public health by enabling timely interventions, such as label modifications, risk minimization strategies, or even market withdrawal, when necessary. This study emphasizes the importance of continuous safety monitoring and the adaptation of regulatory processes to keep pace with emerging safety data.
Author: S. Upadhyay*, Sakshi Joshi, Vinit Movaliya, Arnab Majumedar, Bhavik Joshi
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W6930942947
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