As acknowledged in the recommendations of the HMA-EMA Joint Big Data Task Force (BDTF) and the workplan of the HMA-EMA Joint Big Data Steering Group (BDSG), establishing an EU framework for data quality and representativeness is a critical element for realising the full potential of (big) data and driving regulatory decisions. This document is the first release of the EU data quality framework for medicines regulation and addresses high level principles and procedures that apply across the European Medicines Regulatory Network (EMRN)’s regulatory activities. This framework provides general considerations on data quality that are relevant for regulatory decision making, definitions for data dimensions and sub-dimensions, as well as their characterisation and related metrics. It provides an analysis of what data qualityactions and metrics can be put in place in different scenarios and introduces a maturity model to drive the evolution of automation to support data-driven regulatory decision making.
