The role of real-world data (RWD) and real-world evidence (RWE) in supporting the evaluation of medicines across the different stages of their development and lifecycle is evolving.

To reflect this, the International Conference on Harmonisation (ICH) has released a reflection paper on ‘pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines’. The aim is to further enable the integration of RWE into regulatory submissions and timely regulatory decision-making.