RENATO RJAVEC
Amplexor Life Sciences, Slovenia

Abstract

The European Medicines Agency (EMA) recently confirmed that the UNICOM’s DADI (Digital Application Dataset Integration) project will be used for regulatory data submissions. The move may have been surprising, but it offers opportunities as well as challenges for the pharma industry, says Amplexor’s Renato Rjavec.

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.

Leveraging the parallel DADI project offers a means to maintain progress towards a future of data-driven submissions management and it also relieves a lot of pressure for the pharma industry.

OUT GO PDFS, IN COME WEB FORMS
The DADI project has been running in parallel with IDMP/SPOR (Substance, product, organisation and referential) developments and offers an important step towards o ...