Public consultation on the RWD chapter of the Data Quality Framework

The joint HMA-EMA Big Data Steering Group (BDSG) has launched a public consultation on the draft real-world data (RWD) chapter of the Data quality framework for EU medicines regulation.

This RWD chapter aims to enhance the usefulness of real-world evidence in regulatory decisions by providing guidance on assessing the quality of real-world data used in medicines assessment. It provides recommendations on evaluating the quality of RWD using metrics, characterising reliable data-collection systems and processes, and determining data relevance for research questions

All partners and stakeholders involved in the planning, conduct and analysis of non-interventional studies using real-world data, as well as in the data science field, are invited to provide their input on the draft document via the comments form by 31 January 2025.

The RWD chapter was developed in collaboration with the Methodology Working Party (MWP) and the Committee for Medicinal Products for Human Use (CHMP). It is part of the joint HMA-EMA BDSG initiatives aimed at developing the European medicines regulatory network's capability in data-driven regulation.

Further information: Data quality framework for EU medicines regulation | Submission of comments form | Big Data workplan 2023-2025