FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Finds Europe’s Regulators Unprepared for Big Data

March 13, 2019

European regulators are not prepared to embrace advanced analytics for drug development and they may not understand the gravity of the problem, claims a new report by an EMA task force.

The EMA teamed up with the Heads of Medicines Agency — a network of medicines agencies of the European Economic Area — to analyze Big Data in drug development and found that there is “very limited expertise in big data analytics at national level, but this partly reflects a belief that such expertise is not needed at the current time.”

More than half of national regulators have access to big data sets, such as real-world or observational data, but only six of the regulators reported that they had any collaborative relationship with academic centers.

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