EMA publishes new guidance on real-world evidence generation service

The use of Real-World Data (RWD) is increasingly embedded in the scientific evaluation of human medicines. At the European Medicines Agency, the Real-World Evidence Team (TDA-RWE) of the Data Analytics and Methods Task Force has direct and indirect access to RWD in the form of patient
electronic medical records which can be used to facilitate regulatory evaluations and inform decisionmaking. On this basis, EMA provides a service to generate and deliver Real-World Evidence (RWE) to EMA’s scientific committees, national competent authorities (NCAs), EMA functions and other EU
decision-makers and partner organisations
.
This document briefly describes how RWE, derived from the analysis of RWD, can be useful in the context of regulatory decision-making, the types of studies that can be performed and how EMA can help identify the best resources to address a research question. The process for requesting RWD
studies is also explained.

All work on RWD is conducted in full compliance with data protection legislation