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.

Updated on 1 April 2025

The European Medicines Agency (EMA) continues to have an important role to play in leveraging data to support public health in the European Union (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, see:

• European medicines agencies network strategy
• Substance and product data management services

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 consultation until 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 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:

• 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

• Product Management Service (PMS) information day 2025 (21/05/2025)
• 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