Detailed Explanation
The Periodic Safety Update Report provides a systematic, structured evaluation of a product's safety profile at regular intervals, enabling regulatory authorities to monitor the ongoing benefit-risk balance based on accumulated experience. PSURs integrate safety information from all available sources, including clinical trials, post-marketing surveillance, and the published literature, presenting a comprehensive picture of what is known about the product's risks and the measures in place to manage them. This periodic reporting complements expedited reporting of individual cases by providing aggregate analysis and trend evaluation.