ABSTRACT
The Health Product Safety Agency is one of the most respected regulatory agencies in Europe and enjoys an international reputation for its scientific expertise and independence. This chapter reviews the political, administrative, organizational, and legal influences the Agence du Medicament (AdM) on its successor agency, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS). AdM had regulatory authority to define lists of products and outline standards covering conditions of use and distribution for medicinal products and laboratory reagents. In France, prior to the in Vitro Diagnostic Directive (IVDD), reagents, or in vitro diagnostic products, were embedded in the slowly evolving regime for medicinal products after 1993. La Direction de l'Evaluation des Dispositif Medicaux (DEDIM) is the organizational unit responsible for medical devices and in vitro medical devices. Capacity building in DEDIM moved in several incremental steps and was plagued by two problems: shortage of staff and shortage of experts.
