Capability Development in the European Medicines Regulatory Network: A Cross-Case Analysis of EU-Funded Joint Actions

<title>Abstract</title> <p>Background The European Medicines Regulatory Network (EMRN) operates in an increasingly complex scientific and regulatory environment, creating growing demand for coordinated capability development. EU-funded Joint Actions have become important mechanisms for strengthening regulatory capacity across Member States, yet limited evidence exists on how capability development is implemented and sustained across initiatives. Methods A qualitative cross-case study was conducted across four EU4Health Joint Actions focused on medicines regulation. Data were collected through documentary analysis and semi-structured interviews and analysed using Framework Analysis to examine training modalities, learning processes, knowledge-sharing mechanisms, and sustainability factors. Results Capability development was delivered through a combination of experiential learning, mentoring, peer exchange, and formal training. Learning was predominantly embedded within regulatory practice through activities such as joint inspections, dossier assessment, study visits, and collaborative problem-solving. Despite variation in regulatory focus and programme design, common patterns emerged across initiatives. Collectively, the Joint Actions contributed to an emerging distributed regulatory learning infrastructure that generated shared expertise, professional networks, guidance documents, training resources, and opportunities for harmonisation. However, capability-building activities were often developed independently, with limited coordination across initiatives. Sustainability was constrained by reliance on voluntary expert contributions, project-based funding, and variable application of instructional design and evaluation approaches. Conclusion Capability development within the EMRN is evolving towards a collaborative, practice-integrated learning system. Strengthening coordination, sustainable resourcing, educational expertise, and knowledge-sharing mechanisms could support the development of a more coherent, resilient, and strategically integrated capability development ecosystem across the network.</p>