Pharmacovigilance and Regulatory Affairs

Real-World Evidence in Post-Marketing Surveillance

Real-world evidence (RWE) derived from sources such as electronic health records, insurance claims, registries, and patient-reported outcomes is playing an increasingly vital role in pharmacovigilance. Unlike controlled clinical trials, real-world data captures diverse patient experiences, comorbidities, and medication use patterns, offering a broader view of a product’s safety profile. RWE enhances post-marketing surveillance by enabling earlier signal detection, assessing long-term outcomes, and supporting regulatory decision-making. Its use is especially valuable for evaluating safety in underrepresented populations and rare adverse events. However, challenges remain around data quality, standardization, privacy, and integration across systems. Collaborative frameworks and advanced analytics are key to unlocking the full potential of RWE. As regulatory agencies expand their acceptance of RWE, its role in shaping post-marketing safety strategies will continue to grow significantly.