PSUR/DSUR Templates Explained: Ultimate Guide to Pharmacovigilance Reporting and Compliance Mastering PSUR/DSUR Templates: Compliance-Ready Guide for Global Pharmacovigilance Reporting Introduction to PSUR/DSUR Templates and Their Importance Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) are critical pharmacovigilance documents required by regulators worldwide to evaluate the safety profile of pharmaceutical products. PSURs are submitted for marketed products, while DSURs are required during clinical development. Regulators such as the EMA, FDA, and CDSCO mandate these reports in line with ICH E2C (R2) and ICH E2F guidelines. By 2025, PSUR/DSUR templates have become indispensable tools for ensuring consistent, compliant, and…