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:

Data in regulation: Big data and other sources

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: 04/10/2024

HMA-EMA Network Data Steering Group: membership list

English (EN) (103.02 KB - PDF)

First published: 04/04/2025Last updated: 24/07/2025

For more information, see:

European medicines agencies network strategy

Workplan

The Network Data Steering Group workplan for 2025-2028 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:

Strengthening the network’s data analytics capabilities - this aims to generate high-quality evidence using both established and novel methods
Expanding the coordination centre on Data Analysis and Real World Interrogation Network (DARWIN EU) - this will help deliver evidence that helps fill knowledge gaps and understand the use, safety and benefits of medicines
Advancing the implementation of EMA's Product Management Service (PMS), recognised as 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) published this workplan in May 2025.

Network Data Steering Group workplan 2025-2028

English (EN) (809.88 KB - PDF)

First published: 07/05/2025Last updated: 22/07/2025

Overview of Network Data Steering Group (NDSG) change management activities 2025-2026

English (EN) (112.68 KB - PDF)

First published: 18/09/2025

Meetings

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

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

AdoptedReference Number: EMA/241078/2025

English (EN) (203.17 KB - PDF)

First published: 29/09/2025

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

Reference Number: EMA/198426/2025

English (EN) (226.58 KB - PDF)

First published: 24/07/2025

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)

First published: 06/05/2025

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

AdoptedReference Number: EMA/87142/2025

English (EN) (181.74 KB - PDF)

First published: 06/05/2025

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

AdoptedReference Number: EMA/122343/2025

English (EN) (184.69 KB - PDF)

First published: 06/05/2025

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

AdoptedReference Number: EMA/156282/2025

English (EN) (181.09 KB - PDF)

First published: 16/06/2025

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)

First published: 14/09/2020Last updated: 14/06/2023

Membership list: HMA-EMA joint Big Data Steering Group

English (EN) (135.15 KB - PDF)

First published: 11/09/2020Last updated: 10/09/2024

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

English (EN) (87.38 KB - PDF)

First published: 20/01/2020

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

English (EN) (1.02 MB - PDF)

First published: 28/07/2023Last updated: 20/06/2024

Change management activities delivery plan - HMA-EMA joint Big Data Steering Group

English (EN) (82.31 KB - PDF)

First published: 07/06/2024Last updated: 09/10/2024

Big Data Steering Group (BDSG): 2024 report

Reference Number: EMA/471579/2024

English (EN) (540.29 KB - PDF)

First published: 16/12/2024

Big Data Steering Group (BDSG): 2022 report

Reference Number: EMA/826814/2022

English (EN) (281.09 KB - PDF)

First published: 13/01/2023Last updated: 18/01/2023

Big Data Steering Group (BDSG): 2021 report

Reference Number: EMA/40400/2022

English (EN) (382.67 KB - PDF)

First published: 15/03/2022

Big Data Steering Group (BDSG): 2020 report

Reference Number: EMA/48625/2021

English (EN) (528.47 KB - PDF)

First published: 12/03/2021

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

AdoptedReference Number: EMA/475371/2024

English (EN) (228.57 KB - PDF)

First published: 14/01/2025Last updated: 17/02/2025

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

AdoptedReference Number: EMA/478208/2024

English (EN) (224.27 KB - PDF)

First published: 27/11/2024

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

AdoptedReference Number: EMA/423417/2024

English (EN) (214.68 KB - PDF)

First published: 13/11/2024

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

AdoptedReference Number: EMA/339502/2024

English (EN) (258.18 KB - PDF)

First published: 27/11/2024

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

AdoptedReference Number: EMA/296385/2024

English (EN) (230.88 KB - PDF)

First published: 12/08/2024

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

AdoptedReference Number: EMA/51677/2024

English (EN) (200.45 KB - PDF)

First published: 13/08/2024

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

AdoptedReference Number: EMA/51677/2024

English (EN) (203.03 KB - PDF)

First published: 10/06/2024

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

AdoptedReference Number: EMA/51677/2024

English (EN) (205.15 KB - PDF)

First published: 29/04/2024

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

AdoptedReference Number: EMA/51677/2024

English (EN) (247.94 KB - PDF)

First published: 11/04/2024Last updated: 16/04/2024

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

AdoptedReference Number: EMA/51677/2024

English (EN) (243.93 KB - PDF)

First published: 07/03/2024

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

AdoptedReference Number: EMA/130876/2023

English (EN) (291.59 KB - PDF)

First published: 09/02/2024

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

AdoptedReference Number: EMA/130876/2023

English (EN) (231.5 KB - PDF)

First published: 21/12/2023

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

AdoptedReference Number: EMA/130876/2023

English (EN) (234.21 KB - PDF)

First published: 03/11/2023