Four decades of European medicines regulation: What have they brought us?

Article type: Research Article

Authors: Lisman, John A. | Lekkerkerker, J. Frits F.

Affiliations: Medicines Evaluation Board, The Hague, The Netherlands

Note: [] Corresponding author: J.A. Lisman, Medicines Evaluation Board, Kalvermarkt 53, 2511 CB Den Haag, The Netherlands. E-mail: [email protected].

Note: [] John Lisman is Policy Advisor to the Medicines Evaluation Board. Frits Lekkerkerker is the Chairman of the Medicines Evaluation Board. MEB is the National Competent Authority for medicinal products in the Netherlands: www.cbg-meb.nl.

Abstract: This article gives an overview of the development of the European regulatory system. In 1965 the First Directive on medicinal products was adopted. In 2005 a total revision of the system will come into force. How effective the European Union legislation and regulatory system has been and why has the focus of regulation changed over the years? A famous philosopher said that to know the future, the past has to be explored. From the history of EU pharmaceutical legislation it becomes clear why the law has become as it is.

Journal: International Journal of Risk and Safety in Medicine, vol. 17, no. 1-2, pp. 73-79, 2005