![]() The results obtained will be used to improve preparedness of EMA to future technologies and trends. This research demonstrates the value of collaborative, structured foresight activities. For each signal, the maturity of the technology or trend and its potential impact on medicines regulation and public health was assessed. The most impactful topics for medicines development identified using both approaches are discussed and analyzed in this publication. The strategy used by the WHO’s exercise consisted in a top-down approach led by experts including EU regulators, while the JRC adopted a bottom-up bibliometric method to which EMA contributed, providing domain knowledge for specific sectors ( 6, 7). The two different modalities of signal identification allowed a broad coverage of the innovation and public health landscape. ![]() In this research article, the outcome of horizon scanning exercises conducted by the EMA in collaboration with World Health Organization (WHO) and the European Commission’s Directorate-General Joint Research Centre (JRC) are reported. Therefore, the European Medicines Agency (EMA) adopted horizon scanning as a method for future-proofing and is actively involved in monitoring activities aimed at strengthening the European Regulatory Network preparedness. Horizon scanning is a powerful research tool for identifying, prioritizing and assessing signals of novel developments and issues concerning public health, which could have an impact in the next 3–10 years ( 4, 5). Hence the need for regulatory authorities to not only keep pace with innovation and facilitate opportunities but also to monitor potential future threats via appropriate foresight methodologies. Moreover, as highlighted by the COVID-19 pandemic, immediate and coordinated regulatory actions have been fundamental for the safe and rapid implementation of novel solutions during a crisis ( 2, 3). To make the most of this rapid pace of advancement, in addition to the medicine regulators’ gatekeeping role safeguarding medicines in the EU, they have an increasing role as facilitators or enablers of innovation, providing guidelines and scientific advice to developers prior to the evaluation of marketing authorization applications. This is especially true in medicines development, where the journey from discovery to application is finely regulated, and efficient interactions among multiple stakeholders are crucial for new technologies to be adopted ( 1). For society to benefit to the greatest extent from these innovations, however, the implementation of relevant technologies needs to be facilitated, following an utility evaluation and impact analysis. For example, economic development is driving forward research and development in areas such as biomedicine and computing, enabling bioinformatics and subsequent discovery of new medicinal products. Societal progress is enabling an increasing number of scientific breakthroughs across multiple sectors, many of which have ramifications beyond their sector of origin. For each of these trends, the expected impact and challenges for their adoption are discussed, along with recommendations for developers, regulators and policy makers. A subset of 25 technological trends, divided into three clusters were selected and reviewed from the perspective of medicines regulators. These collaborative exercises aim to inform policy-makers of new trends and increase preparedness in responding to them. This article provides the results of systematic horizon scanning exercises conducted by the Agency, in collaboration with the World Health Organization (WHO) and the European Commission’s Joint Research Centre’s (DG JRC). ![]() In this context, the European Medicines Agency uses horizon scanning to shine a light on early signals of relevant innovation and technological trends with impact on medicinal products. Awareness of these developments and their associated challenges and opportunities is essential for medicines regulators and others to translate them into benefits for society. In medicines development, the progress in science and technology is accelerating. 3Faculty of Health Medicines and Life Sciences, Maastricht University, Maastricht, Netherlands.Kolff Institute, University Medical Center Groningen, Groningen, Netherlands 2Department of Biomedical Engineering, W.J.1European Medicines Agency, Amsterdam, Netherlands. ![]() Hines 1,3* Ana Glória Cruz 1 Barbara Ziętek 1 Ralf Herold 1
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