Harmonizing Pharmaceutical Regulation Among the United States, the European Union, and Japan: The ICH Initiative

Abstract

The United States, the European Union and Japan comprise 75% of the world's pharmaceutical market and generate 90% of all pharmaceutical research. Recognizing the need for and benefits of harmonized testing standards the United States, the European Union and Japan formed a joint initiative between the industry and regulators called the International Conference on Harmonization (ICH). The ICH initiative has been underway for over a decade now. This paper will examine the disparate pharmaceutical regulatory regimes of the U.S., the EU, and Japan and will explore the ICH effort and its progress thus far. Part I of this paper overviews the current regulation of new pharmaceuticals in the United States, the European Union, and Japan. Based on these overviews, it will be apparent that the regulatory agencies of these three regions have already made some progress in harmonizing international standards. Part II explores the forces at work behind harmonization and discusses the potential benefits of pharmaceutical harmonization. Part III explains the ICH initiative including the mechanics of the ICH process and its implementation in the three ICH regions. Part IV of the paper addresses problems inherent in, and barriers to the achievement of the goals of the ICH. Finally, Part V of the paper discusses the accomplishments of the ICH thus far and evaluates its impact on the drug review process.