Definition
French agency assessing, authorising and monitoring medicines and devices
The French National Agency for the Safety of Medicines and Health Products (ANSM) is the competent authority responsible for regulating medicines, vaccines, and medical devices in France.
It oversees evaluation, market authorisation, and post-market surveillance. Its mission is to ensure quality, efficacy, and safety of health products while enabling access to therapeutic innovations.
ANSM plays a central role in compassionate and early access decisions, as well as in pharmacovigilance and risk monitoring activities.
Mission and Responsibilities
ANSM’s mission is to protect public health by evaluating, monitoring, and regulating health products. Its responsibilities include:
1. Evaluation and Authorisation
- Assessing marketing authorisation applications (AMM) for national procedures
- Authorising clinical trials conducted in France
- Granting Early Access Authorisations (AAP/AAC) for innovative therapies
- Overseeing advertising and promotional materials for medicines
2. Pharmacovigilance and Safety Monitoring
- Monitoring adverse events and emerging safety signals
- Coordinating national pharmacovigilance networks
- Implementing risk-minimisation measures and product recalls when necessary
3. Market Surveillance
- Inspecting manufacturing, distribution, and import sites
- Ensuring compliance with GMP, GDP, and other quality standards
- Controlling the quality of products placed on the French market
4. Transparency and Information
- Publishing safety communications, recommendations, and regulatory decisions
- Providing scientific and regulatory guidance to healthcare professionals and industry stakeholders
ANSM also contributes scientific expertise to European procedures coordinated by the European Medicines Agency (EMA).
Role in the European Regulatory System
France is a key participant in EU pharmaceutical regulation, and ANSM experts contribute to:
- EMA committees and working groups
- EU pharmacovigilance activities (including EudraVigilance reporting)
- Inspections and quality oversight across Member States
- Regulatory development and harmonisation initiatives
Through this collaboration, ANSM helps shape European standards and supports consistent application of EU legislation.
Products Regulated by ANSM
ANSM supervises a broad range of products, including:
- Prescription and over-the-counter medicines
- Vaccines and biologicals
- Medical devices and in vitro diagnostics
- Blood products and tissues/cells
- Cannabis for medical use (pilot programme)
- Cosmetic and tattoo products
- Raw materials used in pharmaceutical manufacturing
Importance of ANSM in Public Health
ANSM plays a strategic role by:
- Ensuring rapid access to safe, high-quality medicines
- Responding to health emergencies and shortages
- Enforcing strict quality and safety standards
- Communicating transparently with the public and healthcare community
Its decisions directly influence patient safety, therapeutic availability, and regulatory oversight in France.
