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.

Access the ANSM website

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

GIOgio 2

What can the ANSM do for project leaders?

Topics involved

  • Medical devices:
  • Therapeutic, diagnostic, in vitro diagnostic, technical platforms, medical software.

Accessible resources (database, observatory)

Does it fund projects?

No

Link to innovators and entrepreneurs

Discussion and early dialogue between the Agency's teams and innovators in the field of medical devices (manufacturers, academia, start-ups...), in accordance with the ethical framework set by the ANSM.

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.

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