Pharmacovigilance in France

The French pharmacovigilance system is characterized by : a network of thirty one regional pharmacovigilance centres, located to prov ide convenient proximity to healthcare professionals; a causality assessment method, compulsory for all persons involved in pharm acovigilance, to assess the causal relationship between an adverse effect a nd one or more drugs; if necessary, an additional evaluation of the causal relationship will be p erformed using pharmaco-epidemiology methods; a Technical committee and a National Commission of Pharmacovigilance which centralise and assess all the data in order to provide a consensual advice to the relevant authorities on necessary measures, to prevent, or reduce a drug related adverse effect; in the case of an inquiry, the pharmacovigilance department of the pharmace utical company and the network of regional pharmacovigilance centers will p ool their data with the aim to exchange information and ideas.