EMA - Data Quality Framework for EU medicines regulation

14th December 2023

EMA - Data Quality Framework for EU medicines regulation

This document is the first release of the EU Data Quality Framework (DQF) for medicines regulation
and defines high-level principles and procedures that apply across EMA’s regulatory mandate. This
framework provides general considerations on data quality that are relevant for regulatory decision
making, definitions for data quality dimensions and sub-dimensions, as well as their characterisation
and related metrics. It provides an analysis of what data quality actions and metrics should be
considered in different use cases and introduces a maturity model to guide the evolution of automation
to support data-driven regulatory decision making.

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