The French Pharmacovigilance System

The French Pharmacovigilance System has a number of features that make it stand out: it is based upon a network of 31 Regional Pharmacovigilance Centres, co-ordinated by the Pharmacovigilance Unit of the French Agency (AFSSAPS). Regional Pharmacovigilance Centres and AFSSAPS are connected via a national database, which contains adverse drug reactions (ADRs) reported by healthcare professionals. All reports are assessed before entry into the national database, with a common imputability method. The French organisation is based on a decentralised collection and validation of safety data through the Regional Pharmacovigilance Centres and a centralised evaluation and decision-making process at the AFSSAPS.

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