What the European Medicines Agency (EMA)’s choice of Digital Application Dataset Integration (DADI) means for Pharma

7

The EMA’s decision is only the latest twist in the tale of the Identification of Medicinal Products (IDMP). A more data-driven way of managing regulated product data, based on agreed standards, is the future for the pharmaceutical industry and most industry players agree on this. But the EMA’s new stance means that full IDMP-based regulatory data exchange, with a system-to-system interface between pharmaceutical companies and the EMA, now won’t come into effect until after 2023. Until that happens, regulatory teams will have to manually manage data in two separate repositories – information populated via DADI web forms, and the fuller data sets held within their own internal Regulatory Information Management (RIM) systems.