Network Data Steering Group (NDSG)

The Network Data Steering Group (NDSG) combines the former Big Data Steering Group and the Network Data Board into one data governance group. It aims to optimise data use and management in medicines regulation. This is for the benefit of public and animal health in the European Union (EU). The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) manage this group jointly.
HumanVeterinaryData on medicinesRegulatory and procedural guidanceMedicines

The joint HMA-EMA Network Data Steering Group focuses on data that the European medicines regulatory network receives, analyses or offers advice for. 

It supports the delivery of the European medicines agencies network strategy. In particular, the strategic goal to leverage data and artificial intelligence (AI) in regulating human and veterinary medicines in the EU.

For more information, see: 

Mandate, role and membership

The joint HMA-EMA Network Data Steering Group aims to:

  • maximise data use, exchange and interpretation;
  • improve access to data and evidence generation;
  • leverage use of artificial intelligence for better decision-making.

It also advises HMA and EMA Management Board on the implementation of the European medicines agencies network strategy to 2028. 

The steering group's mandate is available below. It includes detailed information on the steering group's role and membership.

Mandate of joint HMA-EMA Network Data Steering Group

Reference Number: EMA/419729/2024

English (EN) (237.57 kB - PDF)

First published:
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HMA-EMA Network Data Steering Group: membership list

English (EN) (102.44 kB - PDF)

First published: Last updated:
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For more information, see:

Workplan

The Network Data Steering Group workplan for 2026-2028 is available, serving to optimise use of data and artificial intelligence.

The workplan sets out how the European medicines regulatory network plans to leverage large volumes of regulatory and health data as well as new tools. This will encourage research and innovation. It will also support regulatory decision-making for safe, effective and high-quality medicines that reach patients faster.

Concrete planned deliverables include:

  • Developing the Network's data analytics and data standardisation frameworks - this will guide investment in data, analytics and standards
  • Supporting the implementation of the European health data space regulation through Darwin EU and key future legislation (e.g. Biotech Act) - this will help prepare the Network for upcoming developments
  • Launching Darwin EU 2.0 and strengthening strategic engagement on real-world evidence - this will generate evidence that addresses knowledge gaps and provides insights into the use, safety and benefits of medicines
  • Transitioning the clinical study data analysis pilot to the routine submission of clinical study data for centrally authorised medicines - this will support the implementation of the new pharmaceutical legislation
  • Developing artificial intelligence guidance for clinical development and pharmacovigilance, together with a roadmap aligned with the Biotech Act - this will support the Network's experts and assessors
  • Enabling discovery and access to Network data assets and advancing the implementation of EMA’s Product Management Service (PMS), the network’s source of product master data for all EU medicines - this will support EU-wide use cases

EMA and Heads of Medicines Agencies (HMA) first published this workplan in May 2025. 

It was last updated in May 2026.

Network Data Steering Group workplan 2026-2028: Data and artificial intelligence in medicines regulation

English (EN) (625.01 kB - PDF)

First published:
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Select the expandable panel below to see the previous version of the workplan, and other related documents.

Network Data Steering Group workplan 2025-2028

English (EN) (809.88 kB - PDF)

First published: Last updated:
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Overview of Network Data Steering Group (NDSG) change management activities 2025-2026

English (EN) (112.68 kB - PDF)

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Network Data Steering Group (NDSG) 2025 annual report

Reference Number: EXT/345765/2025

English (EN) (556.83 kB - PDF)

First published:
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Meetings

Select the expandable panel below to access the Network Data Steering Group meeting minutes: 

HMA-EMA joint Network Data Steering Group meeting - 13 January 2026

Adopted Reference Number: EMA/8958/2026

English (EN) (239.3 kB - PDF)

First published:
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HMA-EMA joint Network Data Steering Group meeting - 8 December 2025

Adopted Reference Number: EMA/323786/2025

English (EN) (225.53 kB - PDF)

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HMA-EMA joint Network Data Steering Group meeting - 6 November 2025

Adopted Reference Number: EMA/323786/2025

English (EN) (190.34 kB - PDF)

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HMA-EMA joint Network Data Steering Group meeting - 6 October 2025

Adopted Reference Number: EMA/323786/2025

English (EN) (188.86 kB - PDF)

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HMA-EMA joint Network Data Steering Group meeting - 17 July 2025

Adopted Reference Number: EMA/241078/2025

English (EN) (203.17 kB - PDF)

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HMA-EMA joint Network Data Steering Group meeting - 28 May 2025

Adopted Reference Number: EMA/198426/2025

English (EN) (226.58 kB - PDF)

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HMA-EMA joint Network Data Steering Group kick-off meeting - 28/29 January 2025

Reference Number: EMA/46938/2025

English (EN) (259.07 kB - PDF)

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HMA-EMA joint Network Data Steering Group meeting - 4 March 2025

Adopted Reference Number: EMA/87142/2025

English (EN) (181.74 kB - PDF)

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HMA-EMA joint Network Data Steering Group meeting - 31 March 2025

Adopted Reference Number: EMA/122343/2025

English (EN) (184.69 kB - PDF)

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HMA-EMA joint Network Data Steering Group meeting - 30 April 2025

Adopted Reference Number: EMA/156282/2025

English (EN) (181.09 kB - PDF)

First published:
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Former steering group and task force

The joint HMA-EMA Network Data Steering Group supersedes the joint HMA-EMA Big Data Steering Group that operated between December 2019 and January 2025.

The previous steering group had replaced the HMA-EMA Big Data Task Force that functioned between 2017 and 2019.

Select the expandable panel below for related information, including on work plans, annual reports and meeting minutes:

Mandate: HMA-EMA joint Big Data Steering Group

Reference Number: EMA/96120/2023

English (EN) (157.22 kB - PDF)

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Membership list: HMA-EMA joint Big Data Steering Group

English (EN) (135.15 kB - PDF)

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Priority recommendations of the HMA-EMA joint Big Data Task Force

English (EN) (87.38 kB - PDF)

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HMA-EMA Joint Big Data Taskforce Phase II report: Evolving data-driven regulation

Reference Number: EMA/520966/2019

English (EN) (1.69 MB - PDF)

First published:
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Workplan 2023-2025: HMA-EMA joint Big Data Steering Group

English (EN) (1.02 MB - PDF)

First published: Last updated:
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Change management activities delivery plan - HMA-EMA joint Big Data Steering Group

English (EN) (82.31 kB - PDF)

First published: Last updated:
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Big Data Steering Group (BDSG): 2024 report

Reference Number: EMA/471579/2024

English (EN) (540.29 kB - PDF)

First published:
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Big Data Steering Group (BDSG): 2023 report

Reference Number: EMA/569310/2023

English (EN) (269.35 kB - PDF)

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Big Data Steering Group (BDSG): 2022 report

Reference Number: EMA/826814/2022

English (EN) (281.09 kB - PDF)

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Big Data Steering Group (BDSG): 2021 report

Reference Number: EMA/40400/2022

English (EN) (382.67 kB - PDF)

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Big Data Steering Group (BDSG): 2020 report

Reference Number: EMA/48625/2021

English (EN) (528.47 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 11 December 2024

Adopted Reference Number: EMA/475371/2024

English (EN) (228.57 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 4 October 2024

Adopted Reference Number: EMA/478208/2024

English (EN) (224.27 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 6 September 2024

Adopted Reference Number: EMA/423417/2024

English (EN) (214.68 kB - PDF)

First published:
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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 19 July 2024

Adopted Reference Number: EMA/339502/2024

English (EN) (258.18 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 24 June 2024

Adopted Reference Number: EMA/296385/2024

English (EN) (230.88 kB - PDF)

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Minutes – HMA-EMA joint Big Data Steering Group teleconference - 27 May 2024

Adopted Reference Number: EMA/51677/2024

English (EN) (200.45 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 22 April 2024

Adopted Reference Number: EMA/51677/2024

English (EN) (203.03 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 22 March 2024

Adopted Reference Number: EMA/51677/2024

English (EN) (205.15 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 26 February 2024

Adopted Reference Number: EMA/51677/2024

English (EN) (247.94 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 30 January 2024

Adopted Reference Number: EMA/51677/2024

English (EN) (243.93 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 5 December 2023

Adopted Reference Number: EMA/130876/2023

English (EN) (291.59 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 30 October 2023

Adopted Reference Number: EMA/130876/2023

English (EN) (231.5 kB - PDF)

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Minutes - HMA-EMA joint Big Data Steering Group teleconference - 29 September 2023

Adopted Reference Number: EMA/130876/2023

English (EN) (234.21 kB - PDF)

First published:
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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 March 2026.

9 March 2026

Publication of the Network Data Steering Group workplan for 2026-2028

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