The European Medicines Agency (EMA) hosted the third Product Management Service (PMS) Info-Day with revamped hybrid format, strengthening alignment across the EU regulatory network.
 
Date: 10/06/2026
 

On 9 June 2026, EMA hosted the third PMS Info-Day at its premises in Amsterdam, bringing together representatives from EMA, National Competent Authorities (NCAs), and Industry stakeholders. Building on the momentum of the 2024 and 2025 editions, this year's event introduced a new hybrid format designed to maximise both accessibility and meaningful engagement by combining a publicly broadcast morning session with interactive, in-person-only discussions in the afternoon.

Key takeaways from the event

  1. Regulatory readiness and strategic enabler: PMS enables the EU regulatory network to confidently meet upcoming legal and policy changes while serving as a strategic digital foundation for future regulatory use cases and digital health innovation. PMS positions the network for compliance with upcoming legal changes and acts as a strategic enabler for digital health.

  2. Shared commitment to data quality: EMA, NCAs, and Industry stakeholders are aligned on the importance of delivering high-quality, fit-for-purpose product data. Marketing Authorisation Holders (MAHs) play a critical role in enhancing data completeness (particularly for shortages-related data) while NCA legacy data qualification improves overall consistency across national and EU-level systems. A more collaborative approach with MAHs was identified as a major key success factor for data quality.

  3. Strong governance and collaboration: a structured Data Quality Framework and coordinated working arrangements via the Network Data Steering Group (NDSG) ensure trusted, consistent, and usable product data across the network. Stakeholders discussed concrete solutions to simplify collaboration and data flows between EMA, NCAs, and MAHs.

  4. Accelerated delivery and public value: the evolving PMS roadmap, with a 2026 focus on public access, data quality, and network mobilisation, drives expanded access, improved data quality, and tangible public benefits. A key milestone is the launch of the beta PMS Public API, increasing transparency and usability of medicinal product data for wider audiences. The roadmap presents a clear alignment of use cases, data, processes, and IT delivery.

Collaboration in action

The Info-Day served as a platform for direct, multi-stakeholder dialogue. The afternoon interactive sessions, a new addition this year, enabled participants to explore two key themes in depth: data quality priorities and working arrangements for simplified data flows.

Industry representatives emphasised the importance of a more collaborative approach with MAHs as a key success factor for data quality. NCA representatives shared concrete examples of how PMS data enables them to simplify their activities and be better prepared. Discussions reinforced the shared goal of driving alignment and consensus across EMA, NCAs, and MAHs, and participants identified practical solutions to improve collaboration and data flows.
 

Next steps

EMA will continue to follow the PMS roadmap with a focus on public access, data quality, and network mobilisation in 2026. The beta PMS Public API will offer wider access to structured medicinal product data, and ongoing efforts around NCA legacy data qualification and MAH data enrichment will further strengthen the consistency and completeness of PMS data. The broad consensus that emerged from the Info-Day reinforces the direction of travel, and the  insights gathered during the afternoon interactive sessions will inform future collaboration and implementation activities.