National Agency for the Safety of Medicines and Health Products (ANSM)
Mission
Support / Regulation
Type of actor
Institutional player
Fields of intervention
Health / Social care / Medical Device
Intervention zone
National
What is the ANSM?
The Agence nationale de sécurité du médicament et des produits de santé (ANSM) is a public institution under the supervision of the Ministry of Health. It ensures the safety of health products and promotes access to therapeutic innovation, on behalf of the French Government. It works alongside health professionals to serve patients in consultation with their respective representatives present in all the Agency's bodies.
Through its assessment, expertise and monitoring policy, the ANSM ensures that the health products available in France are safe, effective, accessible and properly-used.
Missions
Its missions are to:
- authorise the approval of new medicines and biologics
- monitor all health products throughout their life cycle
- study the impacts of their use
- collect and analyse side effect reports
- engage in product quality control at its laboratories
- inspect manufacturing and distribution sites
The ANSM is heavily involved in European and international work. Its activities are very much part of European procedures and its work is coordinated with the European Medicines Agency, the European Commission and the other national agencies of the European Union. It also collaborates with international health organisations.
I have a project, how can contacting the ANSM be of use to me?
- To identify the regulatory framework for my health product
- To access documentation, regulations and doctrine related to the development of my health product
- To prepare an application for authorisation.
At what stage of my project should I contact the ANSM?
The ANSM's Innovation and Guidance Desk (GIO) provides visibility on the steps at which the project leader can enlist its services. See GIO infographic
Découvrir l'ANSM en vidéo
J’ai un projet, en quoi entrer en contact avec l'ANSM m’est utile ?
- Pour identifier le cadre règlementaire de mon produit de santé ;
- Pour accéder à la documentation, réglementation et doctrine liée au développement de mon produit de santé;
- Pour préparer une demande d’autorisation.
À quelle phase de mon projet entrer en contact avec l'ANSM ?
Le Guichet Innovation et Orientation de l’ANSM donne de la visibilité sur les étapes auxquelles le porteur de projet peut faire appel à ses services. Cf infographie du GIO.
Finance-t-elle des projets ?
Non.
Find out more
Practical Guide
Frequently asked questions about the ANSM.
Who is the right person to contact?
The procedure platform of the Innovation and Guidance Desk will select the right person to address your problem (regulatory, scientific, etc.): https://www.demarches-simplifiees.fr/commencer/ansm-guichetinnovationorientation-v1.
Do you charge for your services?
Access to the Innovation and Guidance Desk is free of charge, but some other services (e.g. applications for authorisation) may be subject to a fee.
Can the ANSM support my project individually?
The public-service mission of the ANSM is to provide knowledge about what is expected in terms of health safety and regulatory requirements. While the response will be tailored to the specifics of your product and your questions, it does not provide a general opinion on development as a private consulting agency would.
How do I prepare my application to the ANSM?
You will be asked a number of questions to help you define your request to the ANSM's Innovation and Guidance Desk. The details of your answer will determine who will be assigned to you.
Make sure you have read the online resources on the ANSM website and the regulations in force governing your health product, in particular European Regulation 2017/745 for medical devices.
147 Boulevard Anatole France 93200 Saint-Denis
