The pharmacovigilance system in practice

Directed by the French Agency for the Safety of Health Products (AFSSAPS), the French pharmacovigilance system is in charge of the surveillance of dru gs after they have been provided by AFSSAPS with official marketing authori zations that are in France either 'new drug approval certificates' (AMM) or 'temporary utilization authorizations' (ATU). About 3,700 pharmaceutical p roducts are concerned which are used either for treatment (all drugs and re medies, inclusive plasma-derived blood products), prevention (vaccines, ora l contraception), diagnosis (contrast products,...), or to modify a physiol ogic function (general or local anesthetics). At the national level, the ma in actors of the system are AFSSAPS and its National Commission, the 31 Reg ional Centers of Pharmcovigilance, all the health professionnals, and the p harmaceutical laboratories. Health professionnals are held to notify airy s uspected serious or unexpected adverse effects as quickly as possible. The analysis of data collected by the national report bank permits alerts and i nquiries about drug safety. Furthermore regional centers of pharmacovigilan ce ave responsible for drug information. The French pharmacovigilance syste m works in cooperation with the European Agency for the Evaluation of Medic inal Products. (C) 1999 Elsevier, Paris.