The the data quality framework for EU medicines regulation is available below.
This guideline sets out the criteria for a more consistent and standardised approach to the quality of data used in medicine regulation to support benefit-risk decisions.
It is meant to:
The data quality framework was co-produced by EMA, the Heads of Medicines Agencies (HMA) and the Joint Action Towards the European Health Data Space (TEHDAS).
EMA will work with stakeholders to use the framework’s concepts and develop practical recommendations for assessing the quality level of data. These will initially focus on the domains of real-world data and adverse drug reactions.
On March 2026, EMA made available the real-world data chapter of the data quality framework.
It provides specific guidance on how to assess the quality of real-world data in the evaluation of medicines to enhance its use in regulatory decisions
In addition, a summary of the outcomes of the public consultation on the draft document is also provided below.
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in March 2026.
27 March 2026
Publication of the final version of the document 'Data Quality Framework for EU medicines regulation: application to Real-World Data', as well as the summary of comments that EMA received during the open consultation of the draft document.