[The European pharmacovigilance: regulatory aspects].

UNLABELLED

ESTABLISHMENT: The European pharmacovigilance system has been operating since 1995 when the European Agency for the Evaluation of Medicinal Products as well as two new European registration procedures were established.

STRUCTURE

This system is very similar to the French organization and is based on a decentralized collection and validation of safety data by member states and a centralized evaluation and decision making process at the European Agency for the Evaluation of Medicinal Products performed by the Committee for Proprietary Medicinal Products (CPMP) and its Pharmacovigilance Working Party. A EUROPEAN SYSTEM: In light of the experience gained, the European pharmacovigilance system moved to an interactive system which relies on a close cooperation between member states ensuring the common evaluation and management of safety concerns.