A total of 695 comments were collected from 39 different stakeholders during the public consultation on EMA’s revised reflection paper on the use of real-world data (RWD) in non-interventional studies to generate real-world evidence (RWE). The final version of the reflection paper was published on 3 April 2025. The EMA has now released a summary of the comments received and the decisions made on their basis.
The majority of comments supported the initiative, although some specific topics were of concerns. The main decisions include maintaining the original proposal for the definitions of RWD and RWE. The suggestion that non-interventional studies using RWD should focus on assessing effectiveness rather than efficacy was adopted, as well as the request of additional considerations in cases where RWD is collected through primary data collection, and recommendations on the use of AI, machine learning and natural language processing technologies.