Foundation of a new French Health Regulation Authority

The existing French health authority has been re-organised. In this context, the ANSM (Agence nationale de sécurité du médicament et des produits de santé) has been officially created. The notification of the regulation in the French official journal from 29 April 2012 is part of the new law, dated 29 December 2011, reinforcing the safety of health products (medicinal products and healthcare products). This measure entered into force on 1st May 2012. The new authority replaces the AFSSAPS (Agence française de sécurité sanitaire des produits de santé) and takes on its mission, rights and obligations. In addition, it has been given new responsibilities in the fields of research, patients care studies, collection of data regarding efficacy and tolerance, and monitoring of temporary recommendations for use.

Professor Dominique Maraninchi, ex General Director of the AFSSAPS, has become General Director of the new authority ANSM. Professor Maraninchi - 62 years old - was Professor for cancer research of the University Aix-Marseille and has led the Paoli-Calmettes Institute - the regional institute on combating cancer in Marseille - 16 years long. He was president of the administrative board of the National Institute for Cancer Research between 2006 and 2011. In February 2011, he became the head of the AFSSAPS and started immediately several projects to anticipate the action plan of the new authority. He also launched a re-structuring project to strengthen the efficacy and pro-activity of the new body.

In this context, a re-evaluation programme has been developed on the risk/ benefit balance of certain medicinal products. The re-structuring of measures regarding temporary authorisations for use has also begun and the policy on dealing with interest conflicts has been strengthened.

Next July, Dominique Maraninchi will present to the administration board the milestones of the ANSM strategy - in particular the regulations and the functioning of the new committees.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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