As the use of Real-World Evidence (RWE) expands globally, regulatory agencies in different regions have developed their own frameworks for evaluating the quality and applicability of RWE. These guidelines are crucial for ensuring that the data derived from real-world settings meets the necessary standards for making regulatory decisions on drugs, devices, and therapies.
This page aims to provide an overview of RWE regulations across different geographies. Understanding these regulations is vital for researchers, healthcare providers, and pharmaceutical companies to navigate the complex landscape of RWE in clinical research, post-market surveillance, and regulatory approvals.
European Union
(EMA & National Authorities)
European Medicines Agency (EMA) Guidelines
United States
(FDA & HHS)
FDA Guidance on Real-World Evidence