Current French system of post-marketing drug surveillance.
The French system of drug surveillance is characterized by several original features: thirty regional centres are selected to cover all of France to collect, analyze and enter the adverse drug events in the national data bank. The system is based on a bank of well documented files submitted to a decision of imputation; the report of severe events by prescribers is mandatory; cases are collected either by spontaneous reporting (routine) or by direct request (intensive validation study); the system is being involved in studies of epidemiological type as carried out by the national system of health or a few societies of medicine as well as by the centres themselves in cooperative works on defined populations.
Albengres
E
E
Centre Hospitalier Intercommunal de Créteil, Centre Régional de Pharmacovigilance, France.
Gauthier
F
F
Tillement
J P
JP
D064420:Drug-Related Side Effects and Adverse Reactions; D005602:France; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*