Leveraging Global Labeling to Comply with the EMA’s Emerging IDMP Standard
You may have heard that the European Medicines Agency and EU Health Authorities have stated their intention to receive all Identification of Medicinal Products (IDMP) in structured product labeling (SPL) format. The Food and Drug Administration also stated its intention to receive IDMP information in SPL format in the future. As result of this intended convergence, a global labeling solution can play an increasingly important role in simplifying regulatory submissions in the US and EU in the next 5 years.
Ray Glemser, and John Polhemus of AbbVie presented the importance of global labeling for complying with IDMP at the 4th Annual Pharma Labeling Compliance Conference on March 16th on Leveraging Global Labeling to Comply with the EMA’s Emerging IDMP Standard with the following topics:
- IDMP and its impact on managing labeling content
- Collecting IDMP information consistently
- Business insight from IDMP information
- Planning for the future
- Global labeling solution features that support IDMP