Abstract

Drug regulatory agencies are increasingly pressed by the challenge of finding the appropriate balance between the need for rapid access to new drugs and the need to ensure comprehensive data on their benefits and risks. This dilemma is not new, but has been made more prominent by recent high-profile drug withdrawals and conflicting demands, including the need to improve the efficiency of drug development on one hand, and the need to avoid exposing patients to unnecessary risks or possibly ineffective treatments on the other. Here, we summarize the current demands by stakeholders and the scientific and regulatory issues at stake, describe existing and emerging regulatory approaches, and speculate on future directions, such as evolution of the current regulatory model from a one-off marketing authorization to a life-cycle approach.

Author affiliations

1. Hans-Georg Eichler and Francesco Pignatti are at the European Medicines Agency (EMEA), 7 Westferry Circus, Canary Wharf, London E14 4HB, UK.
2. Bruno Flamion is at the Laboratory of Physiology and Pharmacology, University of Namur, Rue de Bruxelles 61, 5000 Namur, Belgium, and the Agence Fédérale des Médicaments et des Produits de Santé, Place Victor Horta 40, 1060 Brussels, Belgium.
3. Hubert Leufkens is at the University of Utrecht, Sorbonnelaan 16, 3585 CA Utrecht, The Netherlands, and the Medicines Evaluation Board, Kalvermarkt 53, 2511 CB Den Haag, The Netherlands.
4. Alasdair Breckenridge is at the Medicines and Healthcare products Regulatory Agency (MHRA), 10-2 Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK.
5. Disclaimer: the views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMEA or any other regulatory agency, or one of its committees or working parties.

Correspondence to: Hans-Georg Eichler¹ Email: Hans-Georg.Eichler@emea.europa.eu

Published online 12 September 2008

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