27 November 2019 - Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation.
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have established a joint task force to investigate the potential role of ‘big data’ in the context of medicines development and regulation in the European Union (EU).
'Big data' is a widely-used term without a commonly-accepted definition. The HMA/EMA Task Force on Big Data defines big data as ‘extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends, and associations. In general, big data sets require advanced or specialised methods to provide an answer within reliable constraints’.