The European Medicines Agency (EMA) has set up a task force to study how to use the vast amount of electronic health data – known as Big Data – in drug evaluation. High volume (clinical, genomic, social networking or adverse reactions) data has the potential to contribute significantly to the way they evaluate the benefits and risks of drugs during their life cycle. The Danish Medicines Agency will lead the working group composed of experts from the regulatory agencies of the European Economic Area (EEA). In addition, they will have external experts in Big Data analysis.
They will also make recommendations on necessary legislative changes and data security provisions . In addition, they hope to create a road map for the development of the capabilities of Big Data in the evaluation of applications for marketing authorisations or clinical trials for the competent national authorities. Finally, they will collaborate with other regulatory agencies and partners outside the EEA to consider their vision of Big Data initiatives.