'Big data' is a widely-used term without a commonly-accepted definition.

HMA and EMA define big data as extremely large datasets which:

  • may be complex, multi-dimensional, unstructured and heterogeneous;
  • are accumulating rapidly;
  • may be analysed computationally to reveal patterns, trends, and associations.

For more information, see: 

Mandate and membership

The joint HMA-EMA Big Data Steering Group advises the EMA's Management Board and the HMA on prioritisation and planning of actions to implement the ten recommendations from the final report of the former HMA-EMA Big Data Task Force.

This steering group supersedes the former task force, which operated from 2017 until December 2019.

Multi-annual workplan

A workplan is available aiming to increase the utility of big data in regulation, from data quality to assessment and decision-making.

It is patient-focused and guided by advances in science and technology.

It outlines key deliverables and activities for each priority recommendation.

The steering group reviews the workplan annually to cover any emerging topics.

Annual reports

Annual reports are available summarising the key activities and accomplishments of the steering group during the year in question.

They can be accessed via the expendable panel below:

Meeting minutes

The steering group normally convenes once per month.

Its meeting minutes are available via the expandable entry below:

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