EMA's implementation of IDMP in the EU: A Stepwise Approach
The European Medicines Agency (EMA) is adopting a phased implementation of the ISO IDMP standards in the EU with Product Management Service (PMS) Iteration 1. It focuses on a subset of authorised medicinal product data. This marks a crucial step toward harmonised, structured data use across regulatory procedures – supporting key initiatives like the European Shortages Monitoring Platform and integration of structured PMS data in the electronic Application Form (eAF).
We're proud to share that PMS API Write Access has been live since 25 September 2025 – and LORENZ was actively involved during the UAT phase, which successfully concluded at the end of August. In a significant milestone for the industry, LORENZ was one of the first to deliver PMS Enrichment via the API to EMA's PMS Production, marking real progress in the practical implementation of IDMP.
Watch this video to learn more about:
- The role of PMS in enabling data reuse across EU regulatory procedures
- Key deadlines and compliance requirements
- How to manage package-level submissions and enrichment activities efficiently
- Leveraging LORENZ's Gateway Submission module, which supports both the PMS Write API and XEVMPD for seamless, parallel submission processes
Stay informed. Stay compliant. Stay ahead – with LORENZ drugTrack.
About the speaker: Dr. Grace Ng-Krülle is a Senior Business Process Consultant and Lead RA Specialist. Since 2013 Grace helps customers navigate regulatory requirements by improving data quality and ensuring compliance. She is subject matter expert on electronic submissions of structured regulatory data for ISO-IDMP, specifically in the support of the European Network Portfolio.
