Big data are extremely large, rapidly accumulating datasets captured across multiple settings and devices. Coupled to rapidly developing technology, big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine. The rapidly changing data landscape forces regulators to evolve and change the way they access, manage and analyse data and to enable the rapid advances in science and technology.

The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA), established in 2017, is composed of experienced medicines regulators and data experts. The first phase of their work – published in early 2019 – reviewed the landscape of big data and identified opportunities for improvements in the operation of medicines regulation. Recently the HMA and the EMA task force published a report, including practical suggestions.

The report proposes ten priority actions for the European medicines regulatory network in order to make a better use of big data to support innovation and public health.

The most ambitious of these top ten recommendations is the establishment of an EU platform to access and analyse healthcare data across the European Union. It would be used to inform regulatory decision-making with robust evidence from healthcare practice.

The report also emphasises the need to ensure data are 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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