The previous edition of the Info-Day sparked valuable discussions that have since guided PMS-related work. Participants highlighted the importance of PMS as a shared strategic asset for the EU regulatory environment - one that can only be developed and sustained through close collaboration between EMA, National Competent Authorities (NCAs), and the pharmaceutical Industry. Strong commitment was also expressed by NCAs and EMA to connect national product information systems with PMS, ensuring greater synchronisation and consistency between national and EU-level data. In addition, the need to simplify submission processes and data flows emerged as a priority, opening a constructive dialogue with Industry on streamlining data across the entire lifecycle. Finally, the importance of robust data quality monitoring was emphasised, with EMA committing to support Industry through clearer communication on existing data quality issues and their resolution status.
Over the past year, building on these takeaways, EMA has continued the evolution of the PMS Product User Interface (PUI) and PMS Application Programming Interface (API), introducing new functionalities to enhance data viewing, submission processes, and alignment with other EMA systems.
The 2026 Info-Day will once again serve as a platform for the exchange of knowledge, discussion of benefits, and updates on the collaborative progress towards a successful EU implementation of PMS.
The event will be broadcast live via EMA’s YouTube channel from 9:00 to 13:00 (CEST), ensuring broad accessibility for all interested stakeholders. This year’s public programme is intentionally designed as a half-day event to provide a focused and concise agenda, targeting the most relevant strategic and collaborative aspects of PMS. A draft agenda outlining the key topics and sessions will be available soon on the event page. This public session will be followed by afternoon discussions exclusively for onsite attendees at EMA premises.
Make sure to save the date and take advantage of this valuable opportunity to stay informed and engaged in the ongoing development of PMS in the EU!