ABSTRACT
The economics of pharmaceutical development have a significant impact on the strategy for global marketing approval of new drugs. This is particularly true when sponsors develop and register a drug in one country and then seek marketing approval for the new drug product from regulatory bodies in
a different country or region. Although the drug development process may be similar in different regions, differences due to culture, medical practice, demographics, and other factors can impact how and how rapidly new drugs gain access to different markets. For instance, such differences could complicate the registration process when sponsors seek U.S. Food and Drug Administration (FDA) registration of a pharmaceutical product for the U.S. market based on data gathered outside the United States. A thorough understanding of the issues involved and careful execution of the U.S. regulatory strategy can help make the process manageable.
