Data quality framework for medicines regulation

The data quality framework for European Union (EU) medicines regulation offers guidance and recommendations to assess the quality of datasets used in regulatory decision-making.

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:

• help identify, define and further develop data quality assessment procedures and recommendations for current and novel data types;
• support pharmaceutical companies and other stakeholders in selecting data sources for their studies;
• ensure the trust of patients and healthcare professionals in data-driven regulatory decision-making.

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.

Data Quality Framework for EU medicines regulation

Consultation dates: 10/10/2022 to 18/11/2022

Assessing real-world data quality

A draft version of the framework's real-world data chapter was available for public consultation until end of February 2025. 

This refers to the chapter providing guidance on how to assess the quality of real-world data in the evaluation of medicines. It aims to enhance the use of real-world data in regulatory decisions.

The Committee for Medicinal Products for Human Use (CHMP) and its Methodology Working Party developed this draft.

Draft of Data Quality Framework for EU medicines regulation application to real-world data

Draft: consultation closedConsultation dates: 29/11/2024 to 28/02/2025Summary:

This document describes the Real-World Data (RWD) specific recommendations as derived from the Data Quality Framework (DQF) for EU Medicines regulation endorsed by the Committee for Medicinal Products for Human Use (CHMP). It sets out the principles, concepts, and definitions as intended to be applied widely across datasets used in medicine regulatory use cases. It also provides examples and in-depth clarifications on the developed framework elements for characterising, assessing, and assuring data quality in the regulatory context. Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.