La politica regolatoria del farmaco in Europa: I limiti da superare

Everybody acknowledges the merits of the Emea and the progress the European system has permitted in evaluating and approving medicinal products. Nevertheless, the system established in 1995 is ripe for updating and improvement in the light of experience to date, which suggests that the proposed means are not sufficient to fulfil this commitment. Some limitations of the procedures suggested by the European Community Regulations seem to hamper achievement of the real aims. The scientific community needs to identify the problems and propose and debate solutions with the politicians concerned in order to enable the European regulatory authority to fulfil its commitment to the defence of public health.