The future EMEA data bank. The technical challenge and the expectations of a response to the problems of information on medicines

Article type: Research Article

Authors: Wagner, Hans-Georg

Affiliations: European Medicines Agency, EMEA

Abstract: The new regulation on pharmaceuticals, (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 reinforces the legal basis for a European database on medicinal products. Legislators and other stakeholders have great expectations of this database. This paper reviews the legal base for this database, lists other drivers for its implementation, and examines the benefits of such a database for the different stakeholders. It describes the scope of the database in terms of data elements, data sources, data users and data usage. The paper discusses the current implementation plan and addresses technical and other challenges to its successful construction and routine use.

Journal: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 81-93, 2005