EMA Extends PMS Deadlines and Launches New PMS Functionalities for MAHs

On 10 September 2025, the European Medicines Agency (EMA) announced two major updates for Marketing Authorisation Holders (MAHs): extended deadlines for PMS data submissions and the release of new PMS functionalities. While the extended timelines give companies more time to prepare, the upcoming PUI and API capabilities provide powerful tools to simplify and accelerate non-CAPs data enrichment. Together, these changes represent a significant shift in how MAHs manage regulatory data, offering both relief and new opportunities. We have collected them here:

EMA extends PMS data submission deadlines

In response to challenges raised by industry stakeholders, EMA has updated several PMS submission milestones:

• Non-CAPs in the Union List of Critical Medicines (ULCM): Enrichment of structured manufacturer’s data and pack sizes extended to June 2026 (previously end of 2025).
• All other non-CAPs: Enrichment of pack sizes extended to June 2027 (previously December 2026).
• Structured Manufacturer’s data for non-CAPs: Deadline remains December 2026.

These extensions give MAHs additional time to align processes, systems, and resources with new PMS requirements while maintaining pressure to ensure high-quality, structured data.

Training and support for MAHs

To help industry adapt to these new features, EMA is offering dedicated webinars in October 2025:

• PMS PUI Training – Product data submission & bulk edit made easy: 6 October 2025 (10:00–12:00 CEST). Covers new bulk edit functionality and a recap of PUI key features.
• Unlocking PMS API potential – Edit functionality training for MAHs: 16 October 2025 (10:00–11:30 CEST). Focuses on API write functionalities and practical use.

Additional resources are available on the PLM Portal, including the PMS Product UI registration guide, PMS Product UI navigation guide, and the PMS API Implementation Guide based on FHIR standards.

What do the extended PMS deadlines and its new functionalities mean for MAHs?

These two developments - extended deadlines and new functionalities - are closely linked. On one hand, MAHs gain more time to meet PMS requirements; on the other, they now have more powerful tools to make compliance easier and more efficient.

For MAHs, the key takeaways are:

• Use the deadline extensions to strengthen data governance and ensure accuracy.
• Take advantage of the new PUI and API functionalities to scale data entry and reduce manual effort.
• Attend EMA’s training sessions to stay up to date and gain practical knowledge for faster implementation.

EMA’s announcement marks an important step in shaping the future of regulatory data management. While the extended deadlines provide breathing space, the release of PUI and API functionalities signals that the transition to structured, digital-first regulatory data is accelerating. MAHs that act early - leveraging the new tools and preparing their systems now - will be best positioned to stay compliant and competitive.

Quick Facts about EMA’s latest Announcement regarding PMS Data Submission Deadlines and Functionalities:

• EMA extends key PMS (Product Management Service) data submission deadlines.
• Non-CAPs in ULCM extended to June 2026, all other non-CAPs extended to June 2027.
• Structured Manufacturer’s data deadline of December 2026 remains unchanged.
• New PMS Product User Interface (PUI) and API write functionalities available from September 2025.
• EMA will provide training webinars in October 2025 to support industry adoption.