Navigating the Regulatory Maze Upon Process Changes

Abstract Due to a lack of global consensus regarding drug-approval and the necessity of post-marketing changes, today’s pharmaceuticals are approved one market, or one cluster of markets, at a time. This leads to fragmentation of supply, wherein only certain markets can benefit from specified sources of supply. This chapter explains why fragmentation happens, reviews the business case for postmarketing changes, and highlights the impact of divergent regulations globally, giving specific examples from the US, EU, and Japan. It concludes with an appeal for pharmaceutical companies and global regulatory agencies to work together to find ways to reduce fragmentation in order to ensure reliable, timely supply of drugs to patients in need.