BRUSSELS, March 23 (Xinhua) -- The European Medicines Agency (EMA) said in a statement on Thursday that it has established a task force to provide recommendations for the use of big data in assessment of medicines.
EMA worked together with Heads of Medicines Agencies (HMA) to establish this new task force to explore how medicines regulators in the European Economic Area (EEA) can use big data to support research, innovation and robust medicines development in order to benefit human and animal health, said the statement.
The HMA is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the EEA.
The task force will be chaired by the Danish Medicines Agency and EMA and is composed of experienced staff from medicines regulatory agencies in the EEA. Their efforts will be supported by external experts in big data collection analysis.
According to the statement, this task force adopted a number of actions for the next 18 months, such as 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, and collaboration with other regulatory authorities and partners outside the EEA to consider their insights on big data initiatives.
These data might come from electronic health records from millions of patients, genomics, social media, clinical trials or spontaneous adverse reaction reports, said the statement, and 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.