What Is The EMA DADI Project - And Why Is It Critical To IDMP, eCTD, RIM, And More?

By Cary Smithson and Jim Nichols

If you are at all familiar with ISO IDMP (Identification of Medicinal Products), you are likely aware that this complex regulatory initiative has been something of a roller-coaster ride for our industry over the last several years. The latest up (or down, depending on your perspective) is the announcement that IDMP efforts by the European Medicines Agency (EMA) will be aligned with an existing EMA information technology initiative known as DADI, or Digital Application Dataset Integration.

While there is still a great deal of uncertainty around what this announcement means for regulatory teams at biopharmaceutical companies, the broad trend towards implementing master data in a structured way across life sciences – including regulatory – is certain to continue. This blog provides a brief summary of what we know about DADI so far, its implications, and how to continue to prepare for the data-driven transformation of regulatory processes.