A new entity, the French National Agency for the safety of medicine, health products and cosmetics (ANSM) replaces the French Agency for the safety of sanitary of health products (Afssaps). The Agency press release states that “it has the same missions, rights and obligations," in order to “increase the sanitary safety of medicines and health products," along with a new approach of governance and a new organization to assure “increased missions and prerogatives.”
The Agency issued this press release on 30 April, after the 29 April 2012 Journal Officiel issue (Official Journal) has published the decree dealing with the ANSM governance. Indeed, this decree makes it possible to apply one of the major points of the 29 December 2011 law, and the ANSM is implemented on May 1.
“
This substitution goes far beyond only a change of the name
,” the press release explains.
In fact, it implies several changes:
• a new approach of governance, with a Management Board and a Scientific Board,
• a new internal organization that makes it possible to synergize all the scientific and technical expertises,
• new missions and prerogatives: increased resources, a better control on prescriptions and advertisement, a sanitary police,
• new requirements in terms of transparency and independence of the experts that work for the Agency,
•a reinforced share of the information with all the public (health professionals, patients and public at large.)
Thanks to its increased financial means and displaying its new graphic identity, the new Agency has begun to implement its new work: programme to evaluate again the benefit/risk ratio of some medicines, a new frame for the temporary authorizations for …
