It highlights how stakeholders and partners can request real-world data studies from EMA, the types of studies that can be performed and how EMA can help identify resources to address research questions (see document).

A reflection paper on non-interventional studies methodologies using real-world data (RWD) to generate real-world evidence (RWE) for regulatory purposes has been released for consultation until 31 August 2024. The paper will be discussed in a dedicated session at the multi-stakeholder joint HMA-EMA workshop on RWE methods on 14 June 2024.