The variables include descriptions and identifiers of registered products, substances, pharmaceutical products, packaged components and manufactured items to describe the product characteristics. It also includes the context of products such as, by whom is it registered, where, and since when, who approved it, and who manufactured it. In the end, all this information is to be registered to allow for attributing adverse events to the registered product, the pharmaceutical product, a packaged component, a drug substance or a manufacturer. As a result, signal detection can be improved and corrective actions can be made to reduce hospitalization and deaths due to changes in any of those variables.
A key challenge is the lack of authoritative data sources and common terminology
Too often companies have multiple sources with differing terminology for the same information. As a result, employees cannot rely on the information in their Regulatory Information Management (RIM) system completely. The true data is somewhere, obviously, but lack of trust makes people set up their own spreadsheets and databases. So, any time a question is raised, these different sources need to be verified.
Similarly, regulators face the same problems with having multiple sources for the same information and inconsistent terminology. Therefore, the EU regulators implemented a structure called XEVMPD and initiated the development of ISO IDMP. IDMP is a further extension of XEVMPD-like data and data types). Both the EU-EMA and US-FDA are developing standardized terminology to be used for the IDMP structure. The industry should take advantage of these initiatives as they are key to manage unambiguous authoritative data sources within their own organizations. This should be seen as an opportunity for successful digitalization and not only as a compliance-related challenge.