Comparative Analysis of Additional Risk Minimization Measures in the Risk Management Plan in the European Union and...

In this study, we aimed to characterize differences in additional risk minimization measures within the risk management plan for medicinal products approved in both the European Union and Japan. We examined the proportion requiring additional risk minimization measures, types implemented, and content of the related educational materials. Products approved in both regions as of December 2023 were identified. Safety concerns, additional risk minimization measures, and educational materials for healthcare professionals and patients were retrieved and analyzed for each product. We compared the number and proportion of safety concerns covered by additional risk minimization measures, as well as the volume of educational materials, between the two regions. Among 259 products, additional risk minimization measures were present in 33.2% of European Union products and 73.0% of Japanese products. Direct healthcare professional communications were observed only in the European Union, whereas early post-marketing phase vigilance was characteristic of Japan. Controlled access programs were similarly implemented but rarely overlapped. Japanese educational materials covered a greater number of safety concerns and were generally more extensive, whereas European Union materials tended to be more targeted and concise. Japan applies additional risk minimization measures more broadly and gathers information into one material, whereas the European Union emphasizes selective, purpose-specific risk minimization. These differences reflect the distinct regulatory frameworks and healthcare environments. Optimizing additional risk-minimization strategies in Japan may enhance risk mitigation and resource efficiency.