The document provides general considerations that can be applied to a wide range of data sources for the purpose of characterising and assessing data quality for decision making. It also outlines what data quality actions and metrics can be put in place in different regulatory decision-making scenarios and introduces maturity models for the characterisation of data quality for regulatory purposes.

The first release of this framework intends to provide an overarching framework to identify, define and further develop data quality assessment procedures and recommendations for current and novel data types. 

Moving forward, EMA will work with relevant stakeholders to utilise the framework’s concepts and develop practical guidelines for assessing the quality level of data. These guidelines will initially focus on the domains of real-world data (RWD) and adverse drug reactions (ADR). 

Building a European Data Quality Framework for the regulatory use of data sources with associated quality metrics is one of the key 'Data Quality and Representativeness’ deliverables set out in the joint HMA-EMA Big Data Steering Group workplan 2023-2025.

The framework is available on the EMA website. 

In the veterinary domain, the Union Product Database (UPD) Data Quality Framework was launched in April 2023 and is supporting veterinary regulators with achieving the necessary data quality for veterinary medicines product information that is required to enable the smooth functioning of integrated systems. The launch of an enhanced version and progress update to relevant stakeholders is scheduled for January 2024. The UPD Data Quality framework is available for the EU medicines regulatory network colleagues via the EU NTC platform.