Key takeaways from the event

1. Collaborative strategic asset - A data-ecosystem based on standardised and structured product data is a strategic asset for the EU regulatory environment. It can only be created and maintained with collaboration of EMA, NCAs and Industry. PMS will eventually support the full life cycle of the product – both development product and authorized product, expanding on previous PMS objectives. Beyond the clear strategic direction, a longer-term roadmap is instrumental in setting direction.

2. Network commitment - There is strong commitment from NCAs and EMA to connect national product information with PMS to ensure synchronisation and consistency between national and EU-level data. Different member states face different challenges which means they can move at different speeds. An action plan would help clarify when what can be achieved. EMA aims to support where possible, for example through data mapping support for NCAs.

3. Simplifying submissions and data flows - Submissions and data flows need to be simplified, with Industry requesting an open dialogue on how to simplify across the data lifecycle, especially for data qualification. In the near-term, XEVMPD submissions continue to support Article 57 obligations, while also enabling important data enrichments and data enrichment efforts are expanding to cover all products in company portfolios. Industry requests that the timeliness of the release (planned at the end of September 2025) of bulk update for Product User Interface enrichment functionalities, and Application Programming Interface (API) enrichment functionalities, in light of enrichment deadlines, is considered. In the medium-term, a key step toward simplification of submission and data flows includes XEVMPD decommissioning. This would entail submissions of both Investigational and Authorised Medicinal Product data via the PMS API or Product User Interface (PUI), integration with legacy systems during the transition, and then the discontinuation of XEVMPD and full operationalisation of PMS, following a defined cut-off date. In the long-term, the goal is to further reduce the burden on stakeholders by integrating PMS data across regulatory processes and supporting structured data submission throughout the product lifecycle. This approach, from short to long term, follows the Network Data Steering Group (NDSG) recommendations (see dedicated section below).

4. Data quality monitoring - Data quality is critical to effective PMS. In the short-term, better communication on existing data quality issues and their resolution status will help Industry. In the long-term, NCA efforts around legacy data qualification and integration of national and PMS data will ensure required level of data quality and consistency between national and EU-level data.

Collaboration in action
The Info-Day served as a platform for direct dialogue between EMA, NCAs, and Industry leaders. Together, participants examined how PMS can improve regulatory operations and foster greater consistency, automation, and efficiency.
Industry and NCA representatives shared their experiences, including the challenges they face and the strategies they are employing to become PMS-ready. Discussions reinforced the importance of early preparation, consensus, and data governance within and across organisations.
 

Next steps
The timeline for the gradual transition away from XEVMPD and full adoption of PMS will be shared when ready, along with specific support materials and technical guidance for stakeholders. Meanwhile, both the PMS PUI and PMS API continue to evolve, offering new functionalities for data viewing, submission, and alignment with other EMA systems.
 

For additional information

Network aligns on advancing centralised product data – NDSG recommendations endorsed in June 2025
NDSG, with input from the Regulatory Optimisation Group (ROG), has drafted key recommendations for implementing human Medicinal Product Master Data across the EU. The goal is to establish a shared centralised repository of human medicinal product information at EU level, to enhance regulatory efficiency, data quality, and healthcare delivery and supporting the product data lifecycle via a unified entry point. The recommended stepwise approach envisages a first transitional step enabling the submission of product master data in ISO IDMP/FHIR format under the Article 57 legal basis, with discontinuation of XEVMPD once consuming systems have been repointed to PMS. Later steps will see integration with PMS data with regulatory processes. These proposals were endorsed by the Heads of Medicines Agencies (HMA) and the EMA Management Board in June 2025, marking a major step toward data-driven medicines regulation in Europe.