Barriers and Opportunities for Use of Patient Registries in Medicines Regulation

The European Medicines Agency (EMA) established the Patient Registry Initiative to explore ways of supporting the use of patient registries in generating high-quality data for regulatory decision making and to enable a systematic approach to their use. We review barriers and opportunities for using patient registries in medicines regulation. A key aspect is that early discussions between all parties may often help address concerns including heterogeneity of data collection, data quality, data sharing, or questions on safety reporting.