Navigating the Transition from XEVMPD to PMS: Preparing for IDMP Compliance

As the pharmaceutical industry continues its digital transformation, one of the most pressing challenges facing Marketing Authorization Holders (MAHs) today is the transition from XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) to the EMA’s evolving Product Management Service (PMS) database.

“While this shift is part of the broader push toward IDMP compliance, it’s far more than just a data migration - it represents a fundamental change in how we manage, structure, and exchange medicinal product data,” says Beatriz Ugalde, and continues: “This transition is complex, but it’s also an opportunity - one that requires a proactive, structured approach.”

From XEVMPD to PMS: What’s Really Changing?

The transition from XEVMPD to PMS marks a significant step forward in regulatory compliance and data reusability within the pharmaceutical landscape. XEVMPD was introduced to support pharmacovigilance activities, while PMS aims to be a centralized repository of human medicinal product data from across the European Medicines Regulatory Network.

“At its core, PMS introduces a more robust, structured, and interoperable system for medicinal product data management, aligning with ISO IDMP standards. Unlike XEVMPD, which allowed for more flexibility through free-text entries, PMS demands consistency and harmonization in how data is managed,” says Naushina Arshi. The EMA has confirmed that XEVMPD will not be decommissioned as a one-time process, but rather through a stepwise approach.

Navigating Submission Requirements: Critical vs. Non-Critical Medicines

One of the most nuanced aspects of this transition involves the EMA’s phased implementation approach, which prioritizes critical medicines before non-critical medicines. On paper, this staged rollout appears manageable. In practice, it creates pressure points. The EMA developed PMS and the European Shortages Monitoring Platform (ESMP) with interoperability as a foundational principle.

In alignment with this principle, PMS provides structured data that fulfills the ESMP requirements for critical medicines. ESMP monitors and manages the availability of medicines essential for public health. For MAHs, this means submitting structured data for critical medicines before the end of 2025.

Looking Beyond Compliance: Building for the Future

Too often, regulatory compliance is seen as a short-term hurdle - a box to check. But the PMS transition is a clear signal that the future of regulatory affairs lies in data-driven operations.

“Organizations that treat this transition as a strategic opportunity - rather than a compliance burden - will be better positioned to manage future regulatory updates and respond to evolving global standards,” says Rowan Nidd, and continues: "Organizations that embrace this transition early will gain more than compliance readiness. They’ll build stronger data foundations, increase interoperability, and future-proof their organizations - creating a competitive advantage in a landscape where regulatory excellence and speed to market go hand in hand.”

Once fully implemented, PMS will meet the legal obligations outlined in Article 57 of Regulation 726/2004. The move from XEVMPD to PMS is more than just a system change - it’s a mindset shift. And while the transition is undoubtedly complex - particularly when balancing timelines for critical and non-critical medicines - it’s also a chance for MAHs to future-proof their regulatory infrastructure.