The vision on Big Data is a strengthened regulatory system that can efficiently integrate data analysis into its assessment processes to improve decision making. Knowing when and how to have confidence in novel technologies and the evidence generated from Big Data will benefit public health by accelerating medicines development, improving treatment outcomes and facilitating earlier patient access to new treatments.
The 4th joint HMA-EMA Big Data Steering Group (BDSG) workplan was adopted in June 2023 and covers activities until 2025.
This document introduces each topic and outlines key deliverables. The plan was informed by stakeholder and expert consultation. The document is structured in line with the key recommendations of the Big Data Task Force (see Annex I). The scope of activities under these recommendations covers mainly human medicines, however veterinary aspects are included when relevant.
Progress is delivered in line with the agreed workplan and the Network Strategy to 2025 to enable the use and establish the value of the Big Data in the development, authorisation and supervision of medicines in EU.