Back to: Global IDMP Implementation – Getting Closer to the Goal
🔔 Note: Stop playback at 1:05:36 to complete this lesson.
Presenter
Ta-Jen Chen
Project Management Officer
Office of Strategic Programs
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This presentation details the significant progress and collaborative efforts towards global IDMP implementation, highlighting regional readiness and opportunities. Regulators worldwide are committed to adopting the global IDMP framework, despite varying stages of implementation. The FDA has a long history of aligning with IDMP standards and now drives harmonization, having published final guidance in 2023 and established collaboration with EMA in 2019. Other key players include EMA, implementing IDMP through their Spore Master Data Project and aligning regional PhPIDs with global ones, and ANVISA, which sees IDMP as a strategic program to enhance regulatory efficiency and patient safety. SwissMedic integrates IDMP into its digital transformation for improved data exchange and transparency. The Norwegian Medical Product Agency (NOMA) demonstrates practical PhPID use cases in hospital settings and tests global PhPID APIs for national mapping. Health Canada emphasizes IDMP’s role in creating a common language for health product data, improving traceability and transparency. A key facilitator for global data exchange is HL7 FHIR, which supports the UMC PhPID operating model for submitting, retrieving, and publishing PhPIDs, successfully demonstrated in cross-border scenarios. Global collaboration is crucial for faster responses to drug shortages and adverse events, ultimately protecting patients and saving costs.