French 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 ANSM?
The Agence nationale de sécurité du médicament et des produits de santé (ANSM) is a public body under the authority of the French Ministry of Health. On behalf of the State, it ensures the safety of healthcare products and promotes access to therapeutic innovation.
Missions
- Authorize the marketing of drugs and biological products;
- Monitor all healthcare products throughout their life cycle;
- Study the impacts of their use;
- Collect and analyze reports of adverse reactions;
- Control product quality in 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 carried out in coordination with the European Medicines Agency, the European Commission and other national agencies of the European Union. It also collaborates with international health organizations.
Discover ANSM on video
I have a project. How can contacting ANSM help 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 authorization.
At what stage of my project should I contact ANSM?
The ANSM's Guichet Innovation et Orientation provides visibility on the stages at which project developers can call on its services. Cf GIO infographic.
Does it finance projects?
No
Accessible resources
Practical Guide
All the questions you need to ask about ANSM.
Do you charge for your services?
Access to the innovation and guidance desk is free, but certain other services (authorization requests) may be subject to a fee.
Can ANSM provide individual support for my project?
As a public service, ANSM's mission is to provide knowledge on expectations in terms of health safety and regulatory requirements. While its response is tailored to the specifics of your product and your questions, it does not provide a global opinion on development as a private consultancy would.
The ANSM's mission is to provide knowledge on expectations in terms of health safety and regulatory requirements.How do I prepare my application to ANSM?
You will be asked a number of questions to help you define your request to ANSM's Guichet Innovation et Orientation. The accuracy of your response will determine the contact person assigned to you.
Make sure beforehand that you have familiarized yourself with the online resources on the ANSM website as well as the regulations in force governing your healthcare product, in particular European Regulation 2017/745 for medical devices.
147 Boulevard Anatole France 93200 Saint-Denis
The ANSM: A key player in healthcare innovation and safety
The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) plays a crucial role in France's healthcare ecosystem. Headquartered in Saint-Denis, with branches in Lyon and Paris, the agency ensures patient safety while facilitating access to therapeutic advances.
Supporting innovation
The ANSM has set up the Guichet Innovation et Orientation (GIO) to support carriers of innovative projects. This service offers:
- Personalized regulatory advice
- Support at key stages of development
- Assistance with strategic planning
The GIO has already accompanied more than 700 innovative projects since 2020, facilitating innovators' decision-making. ANSM stakeholders also inform the decision-making process with their expertise and knowledge of the field.
From development to marketing
The ANSM is involved at every stage in the life cycle of healthcare products, including drugs and medical devices:
- Clinical trial authorization: Assessment of protocol safety
- Pre-marketing assessment: Analysis of efficacy and safety data
- Post-marketing surveillance: Follow-up to detect possible adverse effects
The agency also plays a crucial role in the marketing authorization decision for healthcare products.
European collaboration
The ANSM works closely with the European Medicines Agency (EMA), offering French innovators expertise recognized at continental level.
Priority areas of innovation
The agency focuses particularly on:
- Advanced therapy drugs
- Breakingthrough medical devices
- In vitro diagnostic solutions
- Digital health technologies
Supply management
Faced with supply challenges, ANSM works to:
- Anticipate the risks of shortages
- Propose therapeutic alternatives
- Ensure continuity of treatment
Information and transparency
The ANSM is committed to providing clear and precise information on the use of healthcare products, including in vitro diagnostic devices, to healthcare professionals and the public. This transparency is essential to inform the decisions of healthcare professionals and ensure the optimal use of healthcare resources. ANSM also ensures that information is accessible to all, facilitating the effective use of healthcare products.
In parallel, the Innovation Santé 2030 plan aims to boost employment in the healthcare sector in France, by supporting innovation and creating job opportunities in biomedical research and healthcare product production. This includes medical devices and digital solutions, helping to boost employment in this key sector.