The Big Data Steering Group (BDSG) has adopted the report on its 2023 activities. Significant progress in the transformation to data-driven regulation continued in 2023, in line with the European medicines agencies network strategy to 2025 and the 4th BDSG workplan 2023-2025. This also includes the AI workplan 2023-2028 for the European medicines regulatory network to guide the use of AI in medicines regulation in Europe to 2028.