The European Medicines Agency and the Regulation of Medicines in the European Union

Abstract Since its creation in 1994 the European Medicines Agency (EMA) has become a reference medicines regulatory authority for the European Union. It coordinates the expertise of the European regulatory network for the evaluation and post-authorization monitoring of human and veterinary medicines. The EMA provides advice to applicants throughout the development of medicines, thereby facilitating early availability of medicines. In the context of globalization of manufacturing and clinical trials the EMA has engaged in cooperation with trusted regulatory authorities throughout the world. Under the confidentiality arrangements with the FDA, EMA ensures sharing of information, pooling of expertise, leveraging of resources and avoiding duplication with the aim of bringing new effective and safe medicines earlier to patients.