European drug regulatory system is "now unattractive," says CPMP chief

The European Union's centralized procedure for the registration ofmedicinal products is running reasonably well, being fast, efficient and relatively transparent, but the mutual recognition procedure is far from satisfactory, according to Jean-Michel Alexandre, who is chairman of the European Medicines Evaluation Agency's Committee for Proprietary Medicinal Products.

Prof Alexandre told the Drug Information Association's annual Euromeeting, held in The Hague, the Netherlands, last week, that the mutual recognition procedure as it stands provides no systematic recognition of the product's first assessment, no common work on each dossier and no arbitration, which he says cripples the procedure and provides a summary of product characteristics which breaks down the product's national SPC without giving any guarantee of a better level of information.

Not compatible with EU aims/objectives