EU Taskforce of Pharma Regulators Issues its First Report on Big Data

Regulatory NewsRegulatory News
| 04 March 2019 | By Ana Mulero 

A European drug regulators’ taskforce on big data published its first report on Friday.

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) formed the HMA-EMA Joint Big Data Taskforce to harness the potential of data in development and oversight, starting with the new report. They examined clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real-world data (RWD) to inform the work and reach “an important milestone”—a definition of big data.

The taskforce’s work coincides with the global push among regulatory authorities to improve and increase the use of big data, particularly RWD. The push calls for achieving data of regulatory grade.

The new 48-page report defined the term “big data” as “extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analyzed computationally to reveal patterns, trends, and associations. In general, big data sets require advanced or specialized methods to provide an answer within reliable constraints.” It provides a few more details on this definition and points to the formation of six big data subgroups.

The report is intended to provide an overarching summary of reports generated by the six subgroups and recommendations for steps needed to further advance more robust big data to inform regulatory decision-making. It also defines the scope and outputs of the HMA-EMA Join Big Data Taskforce.

“The report is the first step to address the most important challenges facing the authorities and the life science industry when it comes to using big data,” said Nikolai Brun, medical director at the Danish Medicines Agency and chair of the European taskforce. "We have identified the most important areas, and the next step is now to find out how and when to start addressing the different challenges.”


To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe.


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