The European Medicines Agency (EMA) and pharmaceutical industry associations agreed on 14 July 2026 to accelerate the transition to the Product Management Service (PMS) as the single source of medicinal product master data, replacing legacy systems such as xEVMPD. The agreement came at the annual Network Data Steering Group (NDSG) meeting with industry stakeholders, co-chaired by Karl Broich of Germany's BfArM and EMA's Peter Arlett.
Industry representatives, including EFPIA, Medicines for Europe, and EuropaBio, expressed strong alignment with NDSG priorities, particularly on data interoperability and PMS master data. They called for building on the momentum of the recent PMS Information Day to support the New Pharmaceutical Legislation (NPL). Key industry requests included improving data quality, optimising the Type 1A variation process by shifting from document-based to data-driven submissions, integrating electronic product information (ePI) into the product lifecycle, and establishing harmonised EU definitions for shortage and marketing status reporting using structured PMS data.
Participants emphasised the need to move from planning to delivery, focusing on practical implementation, interoperability, and process simplification. The meeting noted the importance of integrating PMS, ePI, electronic common technical document (eCTD), and related systems to support an end-to-end, data-centric regulatory process and avoid duplication. EMA and NDSG will further explore how these systems can be better aligned. Industry was also encouraged to participate in upcoming ePI user acceptance testing.
The meeting also addressed PMS data qualification activities, with plans to develop a clear qualification process and explore automation and AI-enabled approaches. Industry representative Remco Munnik will provide EMA with a list of key challenges related to the current xEVMPD acknowledgement process for discussion at the next Regulatory Optimisation Group PMS Industry meeting in August.
The NDSG workplan progress update covered six workstreams, including AI-related activities such as the AI Observatory Report and establishment of an AI coordination group, as well as expansion of DARWIN EU for real-world evidence. Several stakeholder engagement activities, including workshops and public consultations on data standardisation and adverse drug reaction data quality, are planned.
The meeting was attended by industry associations Vaccine Europe, AESGP, Association of Veterinary Consultants, EFPIA, EUCOPE, ACRO, Medicines for Europe, and EuropaBio.