EMA Evolves Approach to Data Use

In a report published on Jan. 20, 2020, the European Medicines Agency (EMA) announced that the joint Big Data Task Force of the EMA and the Heads of Medicines Agencies (HMA) have proposed actions to evolve the approach to big data.

The top recommendation listed in the report is the creation of a platform to access and analyze healthcare data by creating a European network of databases “of verified quality and content with the highest levels of data security.” The database, Data Analysis and Real World Interrogation Network (DARWIN), would be used to inform regulatory decision making. The report also recommends the development of guidelines and resources, the development of process and analyzation skills and training, and development of a EU network to analyze Big Data.

“I look forward to working with the European Commission and national competent authorities to see how these concrete proposals can be implemented to better harness the potential of big data. This will help to further strengthen the robustness and quality of the evidence upon which we take decisions on medicines,” said Guido Rasi, EMA's Executive Director, in a press release.

“The changes proposed will require investment to build up capacity and skills at national and EU levels. This is needed if we want to establish the EU network as a reference for data-driven decision making,” said Thomas Senderovitz, Chair of the HMA Management Group, in the release.

Source: EMA