30 September 2025
PMS is the last piece of the SPOR puzzle and recently EMA published an updated PMS Roadmap. PMS implementation has been in the works for several years and during 2025 the mapping of product data from SIAMED and XEVMPD is ongoing. During the initial migration to PMS, some fields will contain data, while others will have missing information as it was not captured in the source. The next step is for the companies to “enrich” this data for non-centrally approved products where the EMA do not automatically have access to the data. This will be implemented through a staggered approach that is visualized in the PMS roadmap.
The latest update of the timetable extends the deadline for enrichment of structured Manufacturer’s data and pack size for non-CAPs on the Union List of Critical Medicines by 6 months to June 2026 and the enrichment of pack sizes for all other non-CAPs also by 6 months to June 2027. This is due to challenges from the industry in adhering to the previous deadlines.
With the implementation of PMS the SPOR project will, within the coming years, become fully functional as more and more EMA-connected systems draw the data needed for applications from the repository. Hopefully this will streamline many of the processes and make the submissions easier for both the applicant and for the authorities.
Rolf Eriksson
Senior Expert Regulatory Affairs
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