Update on National Drug and Health Products Safety Agency
Please see the following offical statement from Dominique Maraninchi (Director General) from the National Drug and Health Products Safety Agency for your information:
“I am pleased to announce the setting up of the Agence nationale de sécurité du médicament et des produits de santé (National Drug and Health Products Safety Agency) following the publication of Decree n° 2012-597 published on 29 april 2012 on the National Agency of Medicine and Health Product Safety, implementing the Law of 29 December 2011 on strengthening the safety of drugs and health products. It defines the governance, financial and accounting system of the Agency and the arrangements for setting up commissions and working groups serving within the Agency.
The ANSM takes the place of Afssaps on 1 May 2012.
It is in charge of assessing the benefits and risks of all health products throughout their life and makes its decisions in the name of the State so as to ensure patient safety. The ANSM takes on the work of Afssaps but the Law entrusts it with new tasks in the field of research, patient monitoring studies, collecting data on efficacy and tolerance and supervising temporary usage standards (RTUs - référentiels temporaires d’utilisation). It widens its sphere of action in terms of transparency, control of advertising, and patient and professional information. Its powers are strengthened.
We are proud of the new responsibilities entrusted to us and aware of the duties laid on us. Be assured that the ANSM teams are at work to meet these new challenges.
My hope that the ANSM will allow us to continue and develop our collaboration in the interests of patient safety and I thank you for your commitment to us as we aim to successfully complete this mission.”