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HMA/EMA will establish a Joint Big Data Task Force


The European Medicines Agency (EMA) along with the heads of national competent authorities in the European Economic Area (EEA), created a new task force to explore how medicines regulators in the EEA can use big data to support research, innovation and robust medicines development to benefit human health.

The purpose of this taskforce will be to establish a roadmap and recommendations for use of big data in the assessment of medicines. The task force will be presided by the EMA and the Danish Medicines Agency, their efforts will be complemented on an ad hoc basis by external experts in big data collection analysis.

For the upcoming 1 1/2 years, the taskforce agreed on the following actions:

  • Mapping sources and characteristics of big data
  • Identifying the possible applicability and impact of big data on medicines regulation and developing recommendations on necessary changes to legislation, regulatory guidelines or data security provisions
  • Creating 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 of the EEA to consider their insights on big data initiatives

The task force is composed of representatives from the NCAs in Germany, Denmark, Spain, Finland, Hungary, Ireland, The Netherlands, Norway, Romania and UK as well as from EMA.

Such a Big Data Task Force could also provide opportunities for creating in silico standards in healthcare and is therefore certainly worth being monitored closely by the Avicenna Alliance members.