Throughout 2023, the EMA’s specialized body tasked with coordinating pharmacovigilance efforts across the European Union, the Pharmacovigilance Inspectors’ Working Group (PhV IWG), conducted a series of inspections to evaluate the effectiveness of current pharmacovigilance systems in the European Economic Area (EEA), share best practices, and ensure continued industry-wide compliance with European regulations. The report, a 12-page document published by the EMA, outlines how human and veterinary medicinal product pharmaceutical companies in Europe must now revise their pharmacovigilance efforts and update their systems to align better with new EU legislation by running and maintaining comprehensive Quality Management Systems (QMS), robust Pharmacovigilance System Master Files (PSMFs), and enhanced reporting procedures for adverse drug reactions. In addition to the working group's emphasis on the need for Marketing Authorization Holders (MAHs) to maintain comprehensive PSMFs and adhere to Regulation (EU) 2019/6 (the updated veterinary legislative framework which replaced the outdated Directive 2001/82/EC), the report highlights the critical focus on data accuracy, timely reporting of adverse events, and strengthened signal detection mechanisms.