HMA/EMA Joint Task Force on Big Data

The mandate of the joint HMA/EMA Task Force on Big Data is to explore a number of issues regarding the emerging challenges presented by big data by:

  • Mapping relevant sources of big data and defining the main format in which they are expected to exist
  • Identifying the usability or application of big data
  • Describing the current state, future state and challenges with regard to;

    • regulatory expertise and competences
    • the need to specify legislation and guidelines
    • data analysing tools and sysytems needed to handle big data
    • regulators' responsibility for raw data analytics vs sponsor's responsibility

  • Designing a big data roadmap
  • Generating a list of recommendations as well as evaluating the usefulness of big data in the regultory setting
  • Collaborating with FDA, Health Canada and other third party country stakeholders, including ICMRA, to ensure bilateral insights on big data initiatives

Task force to establish roadmap and recommendations for use of big data in assessment of medicines | EMA News Release

Role of big data for evaluation and supervision of medicines in the EU | EMA News Release 15 February 2019

The task force is composed of representatives from the NCAs in DE, DK, ES, FI, HU, IE, NL, UK and from the EMA.

Co-chair: Nikolai Brun, DKMA, DK

Co-chair: Peter Arlett, EMA


Randi Munk-Jakobsen

Key Documents

  • HMA/EMA Joint Task Force on Big Data - Annex IV Survey for Pharmaceutical Industry | pdf
  • HMA/EMA Joint Task Force on Big Data - Annex IV Survey for National Competent Authorities | pdf
  • HMA/EMA Joint Task Force on Big Data - Annex V Survey results | pdf
  • HMA/EMA Joint Task Force on Big Data - Summary report | pdf

Task Force subgroups reports from Phase I

  • Clinical Trial and Imaging Subgroup | pdf
  • Observational data subgroup | pdf
  • Genomics subgroup | pdf
  • Spontaneous ADR subgroup | pdf
  • Data analytics subgroup | pdf
  • Bioanalytical Omics subgroup | pdf
  • Social media/M-health data subgroup | pdf
  • Survey design and analysis | pdf