European Medicines Agency discusses pharmacovigilance with French General Inspectorate of Social Affairs

News 19/05/2011

On Tuesday 17 May, the European Medicines Agency hosted a meeting with the French General Inspectorate of Social Affairs (IGAS) to discuss the current system of the safety monitoring of medicines in the European Union (EU). The meeting formed part of IGAS's ongoing review of pharmacovigilance and medicines regulation in France.

The meeting focused on:

  • the development of the systems of medicines regulation and pharmacovigilance in the EU since the Agency's establishment in 1995;
  • the initiatives taken to reinforce pharmacovigilance in the EU over recent years;
  • the opportunities provided by the new EU pharmacovigilance legislation, including strengthened pharmacovigilance and the increased promotion and protection of public health.

The meeting also provided an opportunity to discuss on the issues surrounding the withdrawal of the marketing authorisations for medicines containing benfluorex, including Mediator, from national markets.

This withdrawal followed the recommendation of the Agency's Committee for Medicinal Products for Human Use in December 2009, concluding that the medicine's benefits did not outweigh its risks, particularly the risk of damage to the heart valves. The Agency's involvement in the review of benfluorex-containing medicines started in November 2009, triggered automatically by the suspension of the marketing authorisation for benfluorex in France.

Prior to this, Member States had discussed the safety of benfluorex on a number of occasions in the Pharmacovigilance Working Party. A chronology of the discussions on benfluorex is available in the PDF iconsummary background document.

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