EMA – Draft of Data Quality Framework for EU medicines regulation application to real-world data

The EMA is currently carrying out a public consultation on the Data quality framework for medicines regulation chapter dedicated to real-world data . The chapter under consultation provides guidance on how to assess the quality of real-world data in the evaluation of medicines. It aims to enhance the use of real-world data in regulatory decisions. This document describes the Real-World Data (RWD) specific recommendations as derived from the Data Quality Framework (DQF) for EU Medic...