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Recommendations made by EMA to unlock big data potential

Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.

In a new report, the joint big data task force of the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) have proposed ten priority actions for the European medicines regulatory network to evolve its approach to data use and evidence generation, in order to make the best use of big data to support innovation and public health.

Big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine as well as help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems, the task force said.

The rapidly changing data landscape forces regulators to evolve and change the way they access, manage and analyse data and to keep pace with the rapid advances in science and technology.

“I look forward to working with the European Commission (EC) 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, Executive Director of the EMA.

Big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine”

The report highlights which of the ten recommendations it sees as priorities. This includes the establishment of an EU platform to access and analyse healthcare data from across the EU. This platform would create a European network of databases of verified quality and content with the highest levels of data security. It would be used to inform regulatory decision-making with robust evidence from healthcare practice, the report explained.

The joint task force has also encourgaed the development of skills to process and analyse big data within the network through training to enhance the capacity of regulators to assess applications for the authorisation of medicines that use big data sources as part of the evidence on benefits and risks. It proposes establishing a learning initiative to track and review outcomes of these types of submissions.

The report also emphasises the need to ensure data is managed and analysed within a secure and ethical governance framework and in active dialogue with key EU stakeholders including patients, healthcare professionals, industry, Health-Technology Assessment bodies (HTAs), payers, device regulators and technology companies.

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