Europe – High-quality data to empower data-driven medicines regulation in the European Union

EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the quality of the data that underpin decision-making on the benefits and risks of medicines in the European Union (EU).

The joint Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has endorsed two documents for public consultation, one looking at the quality of all data types used in regulatory decision-making, the other one focusing specifically on the discoverability of real-world data…