18 - The process of drug development and approval in the United States, the European Union, and Asia

Summary

The process of drug approval in the United States is regulated by the Food and Drug Administration (FDA). The European Union (EU) includes 27 member states, and each member state has its own national regulatory agency responsible for the approval of clinical trial and marketing applications. Clinical studies to support drug development are increasingly becoming more global in nature as trial subjects are recruited from countries throughout the world. The regulatory environment is very dynamic as global health authorities grapple with innovations in science and technology in addition to changes in health policy in their respective countries. Cooperation amongst regulators in regional health authorities has also been advanced through engagement in the International Conference on Harmonization (ICH). The regulations and requirements continue to evolve as further strides are made in the understanding of diseases and the relevant tools, approaches, and therapies for the management of those diseases.