Current French system of post-marketing drug surveillance
Albengres, E.; Gauthier, F.; Tillement, J.P.
International Journal of Clinical Pharmacology Therapy and Toxicology 28(7): 312-314
1990
ISSN/ISBN: 0174-4879 PMID: 2387656 Document Number: 358601
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.