Sharing data across systems: Master data on human medicines

The European Medicines Agency (EMA) and the Heads of Medicine Agencies (HMA) are working together to build a shared centralised repository of product information on human medicines marketed in the European Union (EU). This concept is based on master data, which enable data sharing across systems.

Master data in medicine regulation refers to the core information about a medicine - such as its name, ingredients, and how it is used.

This information stays the same across different systems and processes. It is essential when sharing data across systems, a process also referred to as data interoperability. 

Master data also help by:

• improving the quality and consistency of information;
• reducing duplication of work;
• supporting decision-making and evidence generation with accurate and integrated data.

The capacity to sharing data across systems is one of the pillars of the joint EMA-HMA Network Data Steering Group (NDSG)'s workplan to 2028.

Moreover, ensuring a high level of data interoperability is also a key goal of the European medicines agencies network strategy to 2028.

Product management service

The steering group recognises the product management service (PMS) system as the common source of product master data for all EU medicines.

The PMS can enable the shared repository of product information on human medicines in the EU. This is why the European medicines regulatory network is working to improve the roll-out of it PMS.

The aim is to equip the PMS to serve as a single entry point for submitting and updating information on human master data. 

This is meant to support the full lifecycle of a medicine’s data.

For more information on using data to support regulation, see:

• Data in regulation: Big data and other sources

Recommendations on human master data implementation

The Network Data Steering Group provided recommendations for human master data roll-out and data management in the PMS.

These include operational recommendations from the EMA-HMA Regulatory Optimisation Group (ROG) to support effective and efficient execution. This group represents a key initiative in advancing the European Medicines Regulatory Network's digital transformation. It focuses on aligning EMA's IT systems and services, the so-called Network Portolio, with the IT strategies of national competent authorities. 

The steering group's recommendations aim to equip the shared repository to support the product data lifecycle. A unified entry point for initial and subsequent data submissions is central to this vision.

For more information on the steering group's recommendations, as well as human master data principles and benefits, see:

Medicinal Product master data for better regulation and better health - Network Data Steering Group (NDSG) recommendations for human Product Master Data implementation and data management

AdoptedReference Number: EMA/135628/2025

Building the shared repository

EMA and HMA envisage several phases in setting up the shared repository of product information on human medicines in the EU:

• Master data submission - to enable the submission of product master data in a format that upholds the standards of the International Organisation for Standardisation (ISO) for the identification of medicinal products (IDMP) and the Fast Healthcare Interoperability Resources (FHIR), in line with Article 57
• Decommissioning the Extended EudraVigilance medicinal product dictionary (XEVMPD) - once all related systems have been redirected to the product management service (PMS)
• Integrating PMS data with regulatory processes - to further enhance data consistency and regulatory efficiency 

As of July 2018, EMA publishes data from the Article 57 database on all medicines authorised in the European Economic Area (EEA). This is in line with Regulation (EC) No 726/2004.