Data streams pictured as multitude of interconnecting points

Data in regulation: Big data and other sources

The European Medicines Agency (EMA) bases its regulatory decisions on different types of data. These include ‘big data’ sources like real-world evidence obtained from electronic health records and patient registries. EMA uses rigorous and transparent analytics, such as advanced artificial intelligence-driven methods, to generate insights and evidence that support decisions on the safety, efficacy, and quality of medicines.
HumanVeterinaryData on medicines

The European Medicines Agency (EMA) continues to have an important role to play in leveraging data to support public health in the EU.

This builds on its work to date as an integral part of the European medicines regulatory network. 

These data include:

  • Regulatory submissions data – that marketing authorisation holders or applicants provide to demonstrate the safety, efficacy and quality of a medicine;
  • Substance, product, organisation and referential (SPOR) master data - that are essential for the monitoring of medicines’ safety and shortages;
  • Real-world data - such as electronic health records, patient registry data or datasets from spontaneously reported suspected adverse drug reactions; these data complement the evidence from clinical trials and fill knowledge gaps regarding a medicine.

EMA helps receive, process, generate, manage and analyse such data. 

Furthermore, EMA is involved in implementing the European medicines agencies network strategy to 2028. 

A key priority in this strategy is to invest in data analytics and artificial intelligence (AI).

The overall objective is ensuring that decisions on medicines are well-informed and evidence-based.

For more information on how EMA works, see:

In this section

Real-world evidence

Information on Darwin EU, HMA-EMA catalogues of real-world data sources and studies, and use of real-world data in regulatory decision-making

Big data training curriculum

Training modules for the European medicines regulatory network to develop expertise in integrating big data analysis into decision-making processes

EU network data strategy

The European medicines regulatory network's data strategy focuses on making more effective use of data that the network is hosting. 

The strategy, available below, aims to ensure that data:

  • meet high quality standards;
  • are appropriately organised, standardised and easy to share among regulators and stakeholders.

This approach facilitates collaboration and more informed regulatory decision-making.

The strategy was available for public consultation between November and December 2024.

European Medicines Agencies Network Data Strategy - Increasing the value of data for the benefit of public and animal health

Reference Number: EMA/128369/2025

English (EN) (361.06 KB - PDF)

First published:
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Data standardisation

Data standardisation is the process of representing data in a common format to enable its exchange and shared understanding, also referred to as semantic interoperability.

This process is meant to simplify managing and analysing data, as well as the use of AI.

Data standardisation strategy  

The network's data standardisation strategy sets out principles guiding its definition, adoption and implementation of international data standards.

This strategy is meant to achieve the following:

  • Enable quicker uptake of international data standards across the EU
  • Improve data quality
  • Enable data linkage and data analysis to support medicine regulation

EMA and HMA published the strategy in December 2021. They maintain it to reflect any changing priorities or new requirements.

European Medicines Regulatory Network Data Standardisation Strategy

English (EN) (586.21 KB - PDF)

First published:
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Data standards framework: public consultation

The network is setting up a framework to manage the adoption, creation, updating, and implementation of data standards for both human and veterinary medicines. This is intended for use within the network.

This framework aims to provide a governance approach for identified data standardisation needs. In doing so, it builds on the network's data standardisation strategy.

The draft data standards framework is available for public consultation until 18 September 2026.

Provide your comments via the link below:

To find the draft framework document, go to:

Data protection

Ensuring that personal data are managed and analysed within a secure and ethical governance framework in compliance with EU data protection legislation was one of the recommended priorities of the former HMA / EMA Big Data Task Force.

EU data protection legislation includes:

  • Regulation (EU) 2016/679, known as the General Data Protection Regulation (GDPR), which applies to private and public entities in the EU Member States;
  • Regulation (EU) 2018/1725, known as the EU Data Protection Regulation (EUDPR), which applies to all EU institutions and bodies.

For more information, see:

Big data highlights newsletter

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Issues from June 2023 (Issue 6) onwards are available at the link below:

Previous issues from 2022 until June 2023 are available on EMA's website in PDF format:

News and events

Veterinary big data

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in August 2026.

24 August 2026

'Data standardisation strategy' sub-section under the 'EU network data strategy' section updated to mark the start of the public consultation on EMA's draft data standards framework.

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