Abstract
Since the European Medicines Agency was created in 1995, it has engaged in dialogue with its various stakeholders, including patients and other representatives of civil society. The establishment of the Patients' and Consumers' Working Party represented a key step forward in the formalization of this interaction. The working party has played a crucial role in facilitating the integration of patients and consumers in various regulatory activities. This article describes how this group operates and gives a detailed overview of the interaction between the agency and the patients' and consumers' organizations focusing on the main achievements to date.