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New law introduces tougher rules on drug regulation in France

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d8309 (Published 22 December 2011) Cite this as: BMJ 2011;343:d8309
  1. Paul Benkimoun
  1. 1Paris

The lower house of the French parliament, the National Assembly, adopted the government’s bill to overhaul the safety of medicines on 19 December—a move that the minister of health said aimed to prevent scandals such as the one surrounding Servier’s antidiabetes drug benfluorex.

The law establishes a new agency, the National Agency for Medicines and Health Products Safety (Agence Nationale de Securité du Médicament (ANSM)), that will take over from AFSSAPS (Agence Française de Securité Sanitaire des Produits de Santé). AFSSAPS has been under fire for having left benfluorex (Mediator) on the market for 30 years despite evidence of harm for many years and …

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