As a major player in public health serving patients’needs, ANSM acts on behalf of the State to ensure that the health products available in France are safe, effective, innovative, accessible and properly used.
We are guided by a strategy which includes four areas of focus:
- An agency that guarantees patient safety in the use of healthcare products;
- An agile agency that supports innovation;
- An agency that listens to and serves the public;
- An efficient and committed agency.
An agency that guarantees patient safety in the use of healthcare products
Guaranteeing patient safety means providing the right information to users, patients and healthcare professionals, both upstream and downstream of the use of healthcare products. We therefore disseminate information on the proper use and prescription of healthcare products. We also monitor the adverse effects reported to us, and are diversifying our sources to ensure that our monitoring is as close to the ground as possible.Guaranteeing patient safety also means guaranteeing the availability of these health products throughout France. In this context, we are actively involved in the fight against shortages. ANSM anticipates, detects and manages these situations to ensure continuity of care for patients, in liaison with all the players involved.
Guaranteeing patient safety also means working to combat emerging risks. Working with all those involved in research and public health, we do our bit to identify new risks as early as possible, so that we can act more effectively to prevent them from occurring in the first place.
An agile agency that supports innovation
The notion of innovation is essential when it comes to defining our challenges for the years ahead.We supervise and support the safe availability of innovative healthcare products, so that patients who need them can quickly access innovations that represent a major therapeutic advance or meet an uncovered medical need.
Supporting innovation means helping project sponsors to develop innovative products so that they are available to patients as soon as possible if they are of interest.
Supporting innovation also means making healthcare products available as soon as possible in a safe way for patients who have reached a therapeutic impasse. To achieve this, we are regulating early access to certain healthcare products. For example, ANSM authorises and monitors the use of unauthorised drugs or drugs used outside their marketing authorisation, and medical devices before they can be marketed.
Supporting innovation also means organising and exploiting data that can provide information to inform the ANSM's assessments and decisions. We have a great deal of data from our activities. To fulfil its missions as effectively as possible, the Agency must equip itself with decision-making tools and be in a position to use the data to which it has access in its assessments to provide the most reliable and harmonised analyses..
An agency that listens to and serves the public
It is vital that ANSM continues to be transparent in its actions and to listen to users in order to further strengthen trust and credibility as an independent and impartial regulatory authority. This will enable us to work ever more closely, effectively and accurately with the public.Through their expertise and knowledge of the field, the stakeholders present on all our bodies help to inform our decision-making process.
Being open and transparent means continuing the Agency's dynamic of openness, which over the last few years has demonstrated its ability to secure its decisions.
Transparency in ANSM's work also means publishing its work (decisions, reports, minutes of meetings) on the Internet, and producing and distributing information that is accessible to as many people as possible through a variety of channels.
Being attentive and transparent means continuing our efforts to inform users (patients, healthcare professionals) about our decisions and disseminating messages about the proper use of healthcare products to make their use ever safer, using formats and methods of disseminating messages adapted to the target audience and objective.
Finally, to meet these challenges and to be as close as possible to our users, we will be working closely with the regional health agencies (ARS).
Being attentive and transparent means that we have a regional network of stakeholders, so that we have a better understanding of the local situation and its specific features, and can act as effectively as possible, depending on the situation, for the benefit of users of the healthcare system.
An efficient and committed agency
In a constantly changing environment, and against a backdrop of constrained public resources, it is vital that the ANSM remains efficient if it is to carry out its missions successfully. This means adapting to new challenges, particularly technological ones, managing the use of our resources ever more closely, and implementing an environmentally-friendly approach, both in our internal management and in the way we carry out our missions.Guaranteeing ANSM's performance means making the most of its many assets to attract and retain the skilled staff it needs. In this way, we will continue to modernise our working practices to be ever more effective and efficient.
Guaranteeing ANSM's performance also means seeking to automate tasks to free up time and allow staff to devote their time to activities that really require their expertise and are therefore more meaningful.
Guaranteeing ANSM's performance also means pursuing its European commitment. It is impossible to talk about the Agency's performance without referring to all the work carried out at European level. Indeed, we are very involved in these bodies and will continue to play an active part in European work. This will enable us to make France's voice and its specific characteristics heard in the decision-making process, but it will also enable us to continue to share our work with the other Member States, in the interests of health safety for all European citizens.
A new Quality Policy
The Quality Policy creates the link between ANSM's strategy, which is based on its Objectives and Performance Contract (COP), and the Quality Management System, which enables the Agency's strategic orientations to be deployed across all its processes, whether they be steering, business or support processes.
Aligned with the COP, the Quality Policy takes up its strategic guidelines. It reflects our commitment to being a public health agency that is as close as possible to the expectations of our stakeholders and French citizens.
This, for the years 2024-2028, the 4 axes of the quality policy are:
Aligned with the COP, the Quality Policy takes up its strategic guidelines. It reflects our commitment to being a public health agency that is as close as possible to the expectations of our stakeholders and French citizens.
This, for the years 2024-2028, the 4 axes of the quality policy are:
- To be the guarantor of patient safety in the use of healthcare products, in order to ensure that they are available and that patients can benefit from high-quality, safe and effective healthcare products;
- To be agile and support innovation in order to make healthcare products available as soon as possible and in a safe manner, so that everyone can benefit from treatment;
- To listen to and serve the public by offering information tailored to all audiences, even those who are farthest from information;
- To be effective and committed in order to prepare for and adapt to the challenges of tomorrow, and to strengthen our influence at European level.
- Monitoring health products;
- Dealing with high-risk situations;
- Testing health products;
- Inspecting ;
- Combating shortages of medicines;
- Organising the quality control of medical devices and in vitro diagnostic medical devices;
- Examining user requests;
- Authorising new marketing authorizations applications and amendments;
- Managing facilities;
- Authorising clinical trials:
- Supporting innovation.