The European pharmacovigilance: regulatory aspects

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.