The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have reaffirmed their long-term vision for the Product Management Service (PMS) and confirmed priorities for 2026, according to minutes of the 21 May 2026 joint Network Data Steering Group (NDSG) meeting published on 22 June 2026. The meeting, co-chaired by Karl Broich (HMA) and Peter Arlett (EMA), focused on advancing structured medicinal product master data and ensuring its quality for use cases including cross-border data exchange under the European Health Data Space (EHDS).
The NDSG, a joint body of EMA and national competent authorities, discussed several use cases for structured medicinal product master data. Isabel Chicharo (EMA) presented an overview of use cases, including PMS data for EHDS cross-border use and a pilot for public release of PMS data to stakeholders via an API. The group also examined findings from the ROG PMS data qualification feasibility study, presented by Georg Neuwirther (AGES, Austria), and measures to ensure fit-for-purpose data quality driven by use cases, presented by Ana Cochino (EMA). Hilmar Hamann (EMA) outlined next steps for data quality and the European Medicines Regulatory Network (EMRN) working arrangement.
The meeting adopted the agenda and the minutes of the 15 April 2026 NDSG meeting. Participants included representatives from national agencies of Germany, Spain, Netherlands, Austria, France, Sweden, Denmark, and others, as well as EMA staff, the European Commission, and observers from ethics, HTA, and patient groups. The meeting was held via Microsoft Teams from 15:30 to 17:30.
The PMS data quality and use case work directly affects pharmaceutical companies, which will need to ensure their product master data meets new quality standards for EHDS interoperability. National competent authorities face potential administrative burden in aligning data systems with the new requirements. Healthcare professionals and patients stand to benefit from improved data quality enabling safer cross-border prescribing and pharmacovigilance. The pilot API release of PMS data could provide distributors and digital health developers with easier access to structured medicinal product information, potentially reducing costs but also requiring adaptation to new data formats.