The report ‘Evolving data-driven regulation‘ is online, it aims to inform strategic decision-making and planning by the Heads of Medicines Agencies (HMA) and European Medicine Agency (EMA) and to input to the EU Network Strategy to 2025. The report will support regulators and stakeholders seizing the opportunity for data-driven, evidence-based, robust decision-making that will underpin the development, authorisation and on-market safety and effectiveness monitoring of medicines in a rapidly evolving data and analytics landscape. The increasing volume and complexity of data now being captured across multiple settings and devices coupled to rapidly developing technology offers the opportunity to deliver a better characterisation of diseases, treatments and the performance of medicinal products in individual healthcare systems. Big Data can complement clinical trials and offers major opportunities to improve the evidence upon which we take decisions on medicines. Understanding the quality and representativeness of Big Data will allow regulators to select the optimal data set to study an important question impacting the benefit-risk balance of a medicine. Establishing the IT capability and capacity to receive, manage and analyse Big Data will enable the Network to discover insights on the safety, efficacy and use of medicines and explore the validity of claims made by the industry. Building expertise to advise, interpret and analyse Big Data will ensure the EU Network can both meet the challenges of product dossiers which include such data and, moreover, realise the public health and innovation benefits of Big Data. Guiding Big Data’s use by industry, understanding the Big Data evidence submitted, and conducting Big Data analyses will get medicines to patients more quickly and optimise their use on the market.
ELIXIR – an EJP RD member – was mentioned in this report on the potential of big data for EU’s healthcare regulatory framework.
