Globalization and the international trade of drugs and medical products have progressed beyond any single regulatory authority’s ability to effectively ensure the quality, safety, and effectiveness of these products. In the U.S., the importation of foreign sourced products has increased tremendously, accounting for over 80% of the active pharmaceutical ingredients. However, varying drug regulations have resulted in gaps in oversight causing differing views on the acceptable level of risk in public health leading to drug quality related deaths and other serious harms. One clear reason for this compromised system is the differences in how these products are regulated from country to country. Nevertheless, the pharmaceutical and related industries are thriving in the global marketplace. This course is intended to be the first comparative survey into the regulatory frameworks of certain key countries, both developed and developing markets, along with international institutions, such as the World Health Organization, involved in promoting the access and development of safe, effective and quality medical products. This course will also identify the major international non-governmental stakeholders, and the multi-lateral schemes and treatises in which they operate that are intended to assist in the convergence of pharmaceutical laws and regulations.