The European Medicines Agency (EMA) published the final version of the Data Quality Framework for EU medicines regulation following a public consultation. 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.

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.

This framework intends 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.

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

Discover more about the framework on the EMA website.

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