How can big data be used to support assessment of medicines? Creation of an European task force to provide recommendations on the subject

As the result of development of new technology in the health area, a large volume of electronic data has been generated. These data include information from health records, clinical trials, adverse events reports and have the potential to contribute to the benefit/risk assessment of medicines during their development, marketing authorisation (MA) assessment and post-market surveillance.

However, analysis and exploitation of these data is quite challenging as it requires specific tools to generate information useful for regulatory assessment while protecting patient confidential data.

The European Medicine Agency (EMA) and the Heads of Medicines Agencies (HMA) have created a new task force to investigate the challenges the use of big data present. Over the next 18 months, the group is expected to provide:

  • A list of existing relevant sources and format of big data.
  • Conclusions on applicability of big data and their impact on the current legislation, guideline, data protection system.
  • Recommendations on changes to the regulation.
  • A roadmap for the use of big data in regulatory assessment by competent authorities (MAs, clinical trial applications (CTAs)).


The task force will collaborate with regulatory authorities from other countries (US FDA, Health Canada) and partners (members of the International Coalition of Medicines Regulatory Authorities (ICMRA) to seek their opinion on big data initiatives.

The group is chaired by the Danish Medicine Agency (DKMA) and the EMA and is composed of representatives from 11 European countries.

Click here to access the original article on the EMA website.