Together with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to support research, innovation and robust medicines development in order to benefit human and animal health.
The term big data refers to extremely large sets of information which require specialised computational tools to enable their analysis and exploitation. These data might come from electronic health records from millions of patients, genomics, social media, clinical trials or spontaneous adverse reaction reports, to name just a few. The vast volume of data has the potential to contribute significantly to the way the benefits and risks of medicines are assessed over their entire lifecycle.
The task force, chaired by the Danish Medicines Agency and EMA, is composed of experienced staff from medicines regulatory agencies in the EEA. Their efforts will be complemented on an ad hoc basis by external experts in big data collection analysis.
The group has agreed a number of actions for the next 18 months. These include:
- mapping sources and characteristics of big data;
- exploring the potential applicability and impact of big data on medicines regulation and developing recommendations on necessary changes to legislation, regulatory guidelines or data security provisions;
- creation of a roadmap for the development of big data capabilities for the evaluation of applications for marketing authorisations or clinical trials in the national competent authorities;
- collaboration with other regulatory authorities and partners outside the EEA to consider their insights on big data initiatives.