As part of the United States regulatory approval process for new medicines, new uses of existing medicines and the continuous monitoring of safety, companies may be required to conduct additional studies and testing to support the safety and effectiveness of their medicines. In the European Union (EU) companies can be required to conduct additional studies and testing to support the safety and effectiveness of their medicines, or to carry out other defined activities, at any time in the life of a product, These studies, testing and other activities are referred to as post marketing commitments (PMCs). This Web site provides some general information about how post marketing commitment studies are conducted, as well as status information for post marketing commitments listed for US products and for products approved via the Centralized Authorization Procedure (CAP) in the EU.
Food and Drug Administration (FDA) information about US post marketing commitments can be found at the FDA Web site.
European Medicines Agency information about post approval commitments can be found at the European Medicines Agency website.