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).

'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

Network Data Steering Group

Mandate, membership, work plan, annual reports and meeting minutes

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

Artificial intelligence

HMA-EMA joint Big Data Steering Group workplan on AI with related guidance and tools

Use of clinical study data in medicine evaluation

Clinical study data pilot for initial and post-authorisation marketing authorisation applications, with information for applicants

Data quality framework for EU medicines regulation

Guidance and recommendations to assess the quality of datasets used 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

Big data expert reports

Reports supporting EMA's regulatory decision-making work

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.

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

Draft: consultation closedConsultation dates: 15/11/2024 to 31/12/2024Reference Number: EMA/458778/2024Summary:

The European medicines regulatory network data strategy establishes a comprehensive framework to maximize the value of regulatory data while ensuring its quality, security, and ethical use. The strategy aligns with and supports the broader objectives outlined in the draft European medicines agencies network strategy to 2028, particularly in advancing data-driven decision-making and strengthening the network's digital capabilities. Comments should be provided until 31 December 2024 using this EUSurvey form.

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.

European Medicines Regulatory Network Data Standardisation Strategy

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:

• Data protection and privacy

Big data highlights newsletter

Stay up-to-date on the implementation of the Big Data Steering Group work plan with our quarterly highlights

Read highlights

Subscribe to receive Big Data Highlights by email

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

• Big Data Highlights: Issue 6 onwards

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

• Big Data Highlights: Issues 1 - 5

News and events

News announcements

• Harnessing AI in medicines regulation: use of large language models (LLMs) (05/09/2024)
• DARWIN EU® continues expanding its capacity to deliver real-world data studies (06/03/2024)
• Launch of new HMA-EMA catalogues of real-world data sources and studies (15/02/2024)
• Artificial intelligence workplan to guide use of AI in medicines regulation (18/12/2024)
• Reflection paper on the use of artificial intelligence in the lifecycle of medicines (19/07/2023)
• Use of real-world evidence in regulatory decision making – EMA publishes review of its studies (23/06/2023)
• DARWIN EU® has completed its first studies and is calling for new data partners (28/03/2023)
• DARWIN EU® welcomes first data partners (23/11/2022)
• High-quality data to empower data-driven medicines regulation in the European Union (10/10/2022)
• Big data use for public health: publication of Big Data Steering Group workplan 2022-25 (28/07/2022)
• Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making (22/07/2022)
• EMA launches pilot project on analysis of raw data from clinical trials (12/07/2022)
• Big Data strategy for veterinary medicines in the EU (13/06/2022)
• Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU (09/02/2022)
• Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
• Ten recommendations to unlock the potential of big data for public health in the EU (20/01/2020)
• Role of big data for evaluation and supervision of medicines in the EU (15/02/2019)
• Data privacy in the age of big data (19/10/2017)
• Use of big data to improve human and animal health (23/03/2017)
• How big data can be used for the development and regulation of medicines (08/11/2016)

Meetings and workshops

• Fifth EMA/HMA Big Data Stakeholder Forum (28/11/2024)
• Biannual Big Data Steering Group and industry stakeholders meeting - Oct 2024 (25/10/2024)
• Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics (24/09/2024)
• Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods (14/06/2024)
• Biannual Big Data Steering Group and industry stakeholders meeting 2024 (12/06/2024)
• Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting (01/03/2024)
• Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder workshop on Patient Registries (12/02/2024)
• Second biannual Big Data Steering Group and industry stakeholders meeting 2023 (27/11/2023)
• Joint HMA/EMA AI workshop – Smart regulation in a rapidly evolving world (20-21/11/2023)
• HMA/EMA Big Data Stakeholder Forum 2023 (04/12/2023)
• Biannual Big Data Steering Group and industry stakeholders meeting 2023 (26/05/2023)
• Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use (26-27/06/2023)
• Second bi-annual Big Data Steering Group and industry stakeholders meeting 2022 (03/11/2022)
• EU Big Data Stakeholder Forum (01/12/2022)
• Big Data Steering Group and industry stakeholders meeting 2022 (30/05/2022)
• Data quality framework for medicines regulation (07/04/2022)
• EU Big Data Stakeholder Forum (07/12/2021)
• Learnings initiative webinar for optimal use of big data for regulatory purpose (30/11/2021)
• Veterinary Big Data stakeholder forum (01-02/06/2021)
• Data Standardisation Strategy stakeholder workshop (18/05/2021)
• Joint HMA/EMA workshop on artificial intelligence in medicines regulation (19-20/04/2021)
• Technical workshop on real-world metadata for regulatory purposes (12/04/2021)
• EU big data stakeholder virtual forum (15/12/2020)
• Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges (04/05/2018)
• Workshop on identifying opportunities for 'big data' in medicines development and regulatory science (14-15/11/2016)

Veterinary big data

Find out about the the European medicines regulatory network's efforts to move towards a more data-driven culture in the regulation of veterinary medicines

Read about veterinary big data