Module 12 Presentations

IDMP Origins

Due to a world-wide demand for internationally harmonised specifications for medicinal products , the International Conference for Harmonisation (ICH) in collaboration with the International Organization for Standardization (ISO) created a set of 5 standards called ISO-IDMP (IDentification of Medicinal Product). • Consistent identification and reconciliation of product information in adverse event (AE) reports ✓ Individual Case Safety Report (ICSR) – Initial pharmacovigilance (PV) use case • Support electronic submission of product lifecycle information between the industry and regulators ✓ Electronic Common Technical Document (eCTD) ✓ Structured Product Labeling (SPL) • Healthcare Exchanges and Health Information Networks ✓ Electronic Health Records (EHRs) ✓ Electronic Prescribing Systems (ePrescription)

The Organisation for Professionals in Regulatory Affairs