Regulation for the Modern Era of Medical Innovation

As scientific and technological innovation advances, regulatory frameworks keeping pace confront new challenges, including the need to modernize how evidence is generated and evaluated, how standards are applied to emerging therapies, and how new technologies can be deployed to make reviews more efficient. At the same time, greater alignment across countries could reduce duplication of effort and make global development more efficient while preserving each regulator’s authority over approval decisions. Where are regulatory approaches in greatest need to modernize? What would it take to build a system better equipped for the next generation of medical innovation?