Drug safety and pharmaceutical regulation in the age of global development

Abstract

As the drug development landscape becomes more globalized, the trade-off between global and local development pathways has become an increasingly important issue. Trade-offs are observed in a variety of consequences, including the resources and time required for development and the impact on patient health. From a public health perspective, studies suggest that the choice of global development pathways for new drugs by pharmaceutical companies may have a significant impact on drug efficacy and safety in Japan. In particular, the fact that dose-finding or confirmatory Phase III studies in Japan have led to improved post-marketing safety demonstrates the potential value of collecting local evidence. The global vs. local trade-off has been overlooked because we lack the concepts and tools to discuss it rigorously in the current drug evaluation science. We need to build a framework for drug evaluation science for a new generation.