Using RWD in Non-Interventional Studies: EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

The article focuses on EMA's promotion of real-world data (RWD) in non-interventional studies for generating real-world evidence (RWE), addressing methodological aspects, governance, and data quality, aligning closely with FDA guidance but highlighting differences in NIS definitions, aiming to enhance regulatory decision-making and scientific rigor while improving transparency and reliability of industry-generated RWD.