EMA PMS Info Day 2026: The Future of Data-Driven Medicines Regulation in Europe

We are delighted about the opportunity to participate in the European Medicines Agency’s (EMA) PMS Information Day in June 2026, which gave us the chance to learn about and discuss the latest developments with other experts from all over Europe. Here we summarize some of the most important results of this special event.

From Documents to Data

The EMA is moving away from document-heavy workflows toward data-driven regulation. PMS will serve here as a shared “source of truth,” which allows for entering data once and reusing it across multiple regulatory processes. This supports shortages monitoring, pharmacovigilance, variation simplification, and cross-border healthcare.

Data Quality Becomes a Business Priority

More and more life science organizations consider data quality a core business responsibility now, and this is more essential than ever: Organizations must adopt continuous data management instead of periodic submissions, ensuring that their information stays accurate and aligned across EMA, NCAs, and industry.

API-Integration as the New Standard

We need to consider API-driven integration as the coming standard way to interact with regulators for companies. Together with machine-to-machine communication, it is a core enabler of PMS.

The Roadmap to PMS

The transition to PMS will follow a stepwise path:

• Gradual phase-out of XEVMPD

• Support for both PMS and XEVMPD during the transition phase

• PMS becomes the main submission channel by 2029

   

How to Prepare Your Organization:

• Invest early in data governance and quality frameworks

• Prioritize API-readiness and scalable integration

• Align internal data models with PMS and IDMP standards

• Train teams to work on data-driven workflows

• Avoid heavy investment in XEVMPD-specific enhancements

The Timelines for Marketing Authorisation Holders (MAH)

The EMA has set clear deadlines for MAHs:

• By the end of June 2026: Complete submission of manufacturers and structured package details for non-CAPs in the ULCM list

• By the end of December 2026: Complete submission of manufacturers for all other non-CAPs

• By the end of June 2027: Submit package sizes and structured package details for all other non-CAPs

Collaboration Will Drive Success

The EMA emphasized that collaboration between regulators, NCAs, industry, and technology partners is essential. Working together will unlock the benefits of PMS and create a unified, high-quality, and future-proof data ecosystem for medicinal products in Europe.