The replacement of the French Agency for the Medical Safety of Health Products (AFSSAPS) by the National Agency for Medicinal and Health Product Safety (ANSM) has been effective since early May. The creation of this new entity follows the various malfunctions that affected the former AFSSAPS in recent years, in particular the concerns about its independence in the case of the Mediator.
The decree organising the ANSM was published in the Official Journal of 29 April 2012, and another decree (1 May 2012) appointed Prof. Dominique Maraninchi as new general manager. Dominique Maraninchi had been heading the former AFSSAPS since February 2011, where he was appointed with the mission to initiate a series of projects anticipating the agency’s reorganisation.
It is not a “simple name change,” the agency said in a statement. Indeed, its powers have been strengthened and its organization and its governance have changed. The law of 29 December 2011, which created the new agency, also sets new requirements for increased transparency and more independence of the experts involved in its work. In particular, rules for managing conflicts of interest were reinforced.
The ANSM will continue the same missions as the AFSSAPS, which cover the evaluation, the inspection, control and regulation of drugs, medical devices and cosmetics.