FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Finds Europe’s Regulators Unprepared for Big Data

March 13, 2019
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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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