"Towards a European FDA? The review of European pharmaceuticals authorization"

Broscheid, Andreas and Feick, Jürgen. (2005) "Towards a European FDA? The review of European pharmaceuticals authorization". In: UNSPECIFIED, Austin, Texas. (Unpublished)

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Abstract

In this paper, we investigate revisions to the system of European medicines authorization that were passed in early 2004. The 1993 legislation establishing the Centralized Procedure of European pharmaceuticals authorization as well as the European Medicines Evaluation Agency (EMEA) (Regulation 2309/93/EEC) provided for a report by the Commission on the experiences with this Regulation six years after the new procedures had come into effect. Following evaluatory reports by different actors, the most extensive one on behalf of the Commission prepared by Consulting firms Anderson and Cameron/McKennan, the Commission launched a broad “review” process in 2001 to revise the existing system, which ended in 2004 with the passage of several pieces of legislation. We are interested in the extent to which the 2004 reforms have expanded the Europeanization of pharmaceuticals regulation in terms of the harmonization of standards, a further shift of regulatory decision-making authority to the European level, and an increase in the "European character" of the regulatory bodies, especially EMEA (now: EMA) and its Scientific Committee, CPMP (now:CHMP). In addition, we try to identify the social, political, and institutional actors whose interests are reflected in the various policy changes, in order to get a sense of whether the changes might have been due to specific demands or whether they seem to exhibit a largely irreversible dynamic.

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