Capability Development in the European Medicines Regulatory Network-A European Learning Needs Analysis and Survey...

The European Medicines Regulatory Network plays a critical role in safeguarding public health through the assessment and supervision of human medicines. However, rapid scientific and technological advancements have exposed capability deficits across the network, threatening timely and effective regulatory decision-making. To identify the most critical learning needs within the European Medicines Regulatory Network-specifically those related to capability gaps-the EU4Health Joint Action, IncreaseNET, conducted a learning needs analysis. This study presents a learning needs analysis conducted via two complementary approaches: stakeholder collaboration with European Medicines Agency expert committees and a network-wide survey of National Competent Authorities. The analysis identified six priority subject areas requiring urgent capability development: Advanced Therapy Medicinal Products, Biologically Active Substances, Clinical Trials, Modeling and Simulation, Pharmacokinetics, and Statistics. Additional training needs-such as Environmental Risk Assessment and Radiopharmaceuticals-were highlighted through the National Competent Authority survey. Key barriers to capability development include uneven distribution of expertise, limited time for training due to high workloads, and recruitment challenges. The study also revealed methodological variation in how learning needs analyses are conducted across the European Medicines Regulatory Network, underscoring the need for a standardized yet context-sensitive framework. IncreaseNET will pilot innovative training development strategies, including the use of pedagogical specialists, formalized training processes, and targeted expert recruitment initiatives. These efforts aim to build a more agile, capable, and resilient regulatory workforce across Europe.