Chapter 2 - Regulatory agencies of the ICH: Authorities, structures, and functions

Abstract

This chapter has as its focus the three major jurisdictions and agencies of the initial International Conference on Harmonization (ICH) that regulate medicinal and medical device products for human use: United States Food and Drug Administration (FDA), the European Union European Medicines Agency (EMA), and Japan’s Pharmaceutical and Medical Device Agency (PMDA). Although they attain the same goal of making safe and effective medical products available for their respective populations, the three jurisdictions have charted their own paths through strikingly different historical contexts to construct regulatory authorities, structures, and processes to attain their common goal. Over the years, other agencies around the world have matured and expanded their reach, with many, like those of China and South Korea becoming more prominent globally.