Pharmaceutical Regulatory Affairs and IPR

The ISO standards for the Identification of Medicinal Products (IDMP) were established in 2012 and updated in 2017. The first region to implement them will be the European Medicines Agency (EMA), which plans to use it to replace their current drug registration system called XEVMPD. Compliance with IDMP will require gathering data that is mostly locked up in narrative documents and systems outside of regulatory control, but has great potential to serve as a master data management system for EMA for improving public safety through better adverse event signal detection, reduction in prescribing errors, and prevention of counterfeit or contaminated product reaching the market. This session will discuss the progress being made toward implementing the standard in Europe as well as in other regions, and will demonstrate the approach needed to gather the information required for compliance.