The system of pharmacovigilance established in the EU aims to promote the safe use of medicines in clinical use thereby protecting public health. During the 1990s existing pharmacovigilance systems in Member States have been brought together to form a Community-wide system that currently covers a population of about 350 million people. The main challenges of the next decade include preparing for expected EU enlargement and the increasing expectations of consumers. In order to meet these challenges, and to efficiently add further value in the protection of public health, the system is continuing to evolve, particularly in response to scientific progress and technological developments.

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