Global Regulation of the Pharmaceutical Sector (3 credits)

Global sales of pharmaceuticals total more than $600 billion annually, with the United States constituting the world’s largest pharmaceutical market. This course addresses legal regulation of the pharmaceutical sector, from research and development to manufacturing and distribution. The principal focus is on U.S. law, including the FDA regulatory system. In addition, the course examines foreign regulation, such as the European pharmaceutical regulatory system, and the role of multilateral agencies, including the World Health Organization. Prerequisites: None