The term big data refers to tremendously large sets of information which involve specific computational tools to enable their examination and exploitation. These data might come from electronic health records from millions of patients, genomics, social media, clinical trials or impulsive adverse reaction reports, to name just a few. The massive volume of data has the potential to contribute suggestively to the way the assistances and risks of medicines are evaluated over their entire lifecycle.
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 provision research, innovation and robust medicines development in order to benefit human and animal health.
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:
- planning foundations and features of big data;
- exploring the potential applicability and influence of big data on medicines regulation and emerging endorsements on necessary changes to regulation, regulatory guidelines or data security requirements;
- formation of a roadmap for the growth of big data aptitudes for the assessment of applications for marketing authorizations or clinical trials in the national proficient specialists;
- Teamwork with other regulatory authorities and partners outside the EEA to consider their understandings on big data enterprises.
Dated: 23rd March 2017
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002718.jsp&mid=WC0b01ac058004d5c1