This session offers a potpourri of various international data initiatives that aim to transform the way medicines are developed, regulated, and find their way to clinical practice. The main question we will try to get answered during this session is: How do we enable and use these data for clinical and regulatory decisions? From the ambitious European Health Data Space (EHDS) to the information-rich electronic product information (ePI) and the newly developed European medicines regulatory database (EMRD): we will dive into the foundations for clinical and regulatory decision making, and the world that drives the use of artificial intelligence.