Data streams pictured as multitude of interconnecting points

Big data

Every day, vast amounts of data are generated that have the potential to inform and improve medicines regulation. In response, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) established a joint steering group to plan and prioritise actions that leverage big data to support innovation and public health in the European Union (EU).
HumanVeterinaryCorporateData on medicinesInnovationResearch and development

'Big data' is a widely-used term without a commonly-accepted definition.

The former HMA-EMA big data task force, which the steering group replaced in 2019, defined big data as extremely large datasets which:

  • may be complex, multi-dimensional, unstructured and heterogeneous;
  • are accumulating rapidly;
  • may be analysed computationally to reveal patterns, trends, and associations.

In general, big data sets require advanced or specialised methods to provide an answer within reliable constraints.

A single dataset may not strictly meet the definition of big data but, when pooled or linked with other datasets, they become sufficiently large or complex to analyse to assume the characteristics of big data.

Sources include real-world data (such as electronic health records, insurance claims data and data from patient registries), genomics, clinical trials, spontaneous adverse drug reaction reports, social media and wearable devices.

Medicines regulators are increasingly using insights derived from big data to assess the benefit-risk of medicines across their lifecycle.

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 draft data strategy was available for public consultationuntil 31 December 2024.

This strategy focuses on making more effective use of data that the EU network is hosting. 

It aims to ensure that data meet high quality standards, and are also appropriately organised, standardised and easy to share among regulators and stakeholders. 

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

The previous Big Data Steering Group and European Network Data Board (currently combined into the Network Data Steering Group) co-developed this draft strategy.

Data standardisation strategy

The European medicines regulatory network's data standardisation strategy sets out principles to guide the definition, adoption and implementation of international data standards by the network.

It aims to:

  • 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 and will maintain it over time to reflect any changing priorities or new requirements.

Data protection

Ensuring that personal data are managed and analysed within a secure and ethical governance framework in compliance with EU data protection legislation is one of the recommended priorities of the 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

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

Share this page