Statut des anti-cancéreux, AMM européenne, quoi de neuf ?

A large number of new anticancer agents are currently under development in order to obtain marketing authorisation. By the end of 2005, centralised European submission will become mandatory for any new drug in the field of oncology. New regulations will apply to the registration of anticancer products. Some of these compounds exert their effects through mechanisms of action that do not involve direct cytotoxicity. A new version of the Guideline for Evaluation of Anticancer Medicinal Products in Man will take this fact into account and will integrate as far as possible the experience linked to the most recent procedures. This paper briefly summarizes the main regulatory changes and their corresponding scientific adaptations. [ABSTRACT FROM AUTHOR]