• Tilo Netzer.
• Merck KGaA, Regulatory Strategy, Frankfurter Strasse 250, 64271 Darmstadt, Germany. tilo.netzer@merck.de
• Eur. J. Cancer. 2006 Mar 1; 42 (4): 446-55.

AbstractIn the European Union (EU) 20 anticancer agents have been successfully authorised via the Centralised Procedure since its implementation in 1995. Public information on these 20 agents has been reviewed in order to evaluate the effectiveness of the available regulatory mechanisms to facilitate the marketing authorisation of such drugs in the EU. These mechanisms include orphan drug legislation, exceptional circumstances provision and the accelerated evaluation procedure. Based on the fact that the EU orphan drug legislation was not implemented before the year 2000 no conclusions on its effectiveness to facilitate oncology drug development can be drawn today. Much more data are available on the effects of the exceptional circumstances provision, which was used in 6 out of 10 cases over the past four years. An analysis of the clinical data packages indicates that this provision allows authorisation of innovative oncology drugs based on smaller clinical data sets than required for full approval. The accelerated evaluation procedure was used in only one case and significantly reduced the scientific review time at the EU agencies. However, this mechanism does not influence the administrative time at the authorities, which accounted for almost one-third of the overall duration of the EU marketing authorisation procedures for oncology drugs. Revision of the EU drug legislation brings about some changes to the above-described provisions, with the potential for an improvement in the current situation. Thus, its implementation offers the chance to reduce the time that innovative oncology agents take to reach the market, although -- based on experience with the current procedures -- more effort is likely to be required to achieve this goal.

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