HMA-EMA joint Big Data Steering Group: Mandate | pdf (June 2023)
Task force to establish roadmap and recommendations for use of big data in assessment of medicines | EMA News Release
Role of big data for evaluation and supervision of medicines in the EU | EMA News Release (February 2019)
The steering group is composed of representatives from the NCAs (7 - hum + vet), EC, eHealth Network (1), EU-IN (1), EU Network Telematics governance (1), CHMP (1), PRAC (1), SAWP (1), CVMP (1), EU Patient associations (1), EU HCP associations (2) and EMA (3 – IT, analytics, communications).
The task force is co-chaired by the HMA and EMA representatives:
- Co-chair: Nikolai Brun, DKMA, DK
- Co-chair: Peter Arlett, EMA
HMA-EMA joint Big Data Steering Group: membership list | pdf
Email: Jolanta.Palepsaitiene@ ema.europa .eu
- HMA/EMA Joint Big Data Steering Group Workplan 2022-2025 | pdf
- HMA/EMA Joint Big Data Steering Group 2022 report | pdf
- HMA/EMA Joint Big Data Steering Group 2021 report | pdf
- HMA/EMA Joint Big Data Steering Group 2020 report | pdf
- HMA/EMA Joint Big Data Steering Group workplan | pdf
Document adopted on 27 July 2020
- HMA/EMA Joint Task Force on Big Data - Annex IV Survey for Pharmaceutical Industry | pdf
- HMA/EMA Joint Task Force on Big Data - Annex IV Survey for National Competent Authorities | pdf
- HMA/EMA Joint Task Force on Big Data - Annex V Survey results | pdf
- HMA/EMA Joint Task Force on Big Data - Summary report | pdf
Task Force subgroups reports from Phase I
- Clinical Trial and Imaging Subgroup | pdf
- Observational data subgroup | pdf
- Genomics subgroup | pdf
- Spontaneous ADR subgroup | pdf
- Data analytics subgroup | pdf
- Bioanalytical Omics subgroup | pdf
- Social media/M-health data subgroup | pdf
- Survey design and analysis | pdf
- HMA/EMA Joint Task Force on Big Data - Phase II report Evolving Data Driven Regulation | pdf
- Priority recommendations of the HMA/EMA joint Big Data Task Force | pdf
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.
- The strategy is a key deliverable of the Big Data Steering Group workplan.
EMA and HMA published the strategy in December 2021 and will maintain it over time to reflect any changing priorities or new requirements.
Use of real-world evidence