The critical role of industry in the PMS and master data
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Hanna Saari
Master data is integral to the EMA’s four data management services: substance, product, organisation and referential (SPOR). The Product Management Service (PMS) is a central plank in the SPOR program and will be used as a trusted source of product information.
EMA is proceeding with its PMS roadmap,2 which most urgently includes providing data to the European Shortages Monitoring Platform (ESMP) and electronic Application Forms (eAFs). Industry will need to work with the agency to submit their data to the PMS and to check and cleanse that data.
Data cleansing needed
Once that data is checked and cleansed, the next step will be to enrich the dataset with information about the manufacturer and their role (for example, are they responsible for producing the active pharmaceutical ingredient or formulating the tablets?), as well as inclusion of the structured packaging data. Manufacturing information will be required for the ESMP to ensure greater transparency over the supply chains.
EMA has extended the deadlines for enrichment of the data for products on the critical medicines list until June 2026 and for other products until December 2026 (manufacturer data) or June 2027 (structured packaging data); however, companies need to act urgently to fulfill these requirements.
There is still a lot to do before enrichment can happen. An important starting point will be to integrate data processes into regulatory processes. Have a clear data governance process in place and make sure there is ownership of the data. And implement proper regulatory information management.
The agency is developing tools to support industry with the transition to PMS. Now it is up to industry to ensure it provides the resources and commitment needed to achieve the goal of a shared repository of trusted product master data.
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Sources:
1. Medicinal Product master data for better regulation and better health, HMA and EMA, May 2025. https://www.ema.europa.eu/en/documents/other/medicinal-product-master-data-better-regulation-better-health-network-data-steering-group-ndsg-recommendations-human-product-master-data-implementation-data-management_en.pdf
2. Product Management Service roadmap, EMA. https://www.ema.europa.eu/en/documents/other/product-management-service-pms-roadmap_en.pdf
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