ANSM

What ANSM does

ANSM (Agence nationale de sécurité du médicament et des produits de santé) is France's national regulatory agency for medicines and health products, operating under the supervision of the French Ministry of Health as an établissement public administratif. Established in 2012 as the successor to AFSSAPS, the agency is headquartered in Saint-Denis with 501-1,000 employees and holds statutory authority over the full lifecycle of medicines, vaccines, biological products, medical devices, in vitro diagnostics, and cosmetics marketed in France. Its mandate spans pre-market authorization, manufacturing facility inspections, post-market vigilance, safety communications, and enforcement actions. ANSM serves pharmaceutical companies, medical device manufacturers, healthcare professionals, patients, patient associations, and clinical trial sponsors operating in French territory.

The agency's core technology stack comprises six coordinated vigilance networks — pharmacovigilance, matériovigilance, réactovigilance, addictovigilance, hemovigilance, and cosmétovigilance — supported by digital platforms including the Vigimater incident tracking application (covering incidents since January 2019), the Data ANSM public data portal, the public drug database (base-donnees-publique.medicaments.gouv.fr), the ReCann national registry for the medical cannabis experimentation program, and the Signalement adverse event reporting portal. These systems aggregate safety signals from 31 regional pharmacovigilance centers (CRPV), matériovigilance and réactovigilance coordinators (CRMRV), addictovigilance centers (CEIP-A), and hemovigilance coordinators (CRH-ST), and feed upward into European-level oversight via ANSM's participation in EMA scientific committees (PRAC, CHMP, CMDh, COMP, PDCO, HMPC) and collaboration with EDQM on pharmacopoeia standards.

ANSM is funded through the French state budget and does not generate commercial revenue; it charges limited administrative fees only for specific services such as lot release of immunological medicines, blood product lot certification, GMP inspection certificates for raw materials, exporter attestations, and pharmacopoeia reference substance delivery. Distribution of agency outputs flows through official bulletins, the ansm.sante.fr website, social channels (Twitter/X, YouTube, LinkedIn), email newsletters, and a press function. Notable recent enforcement actions include a €1.78 million fine against Novo Nordisk and a €108,766 fine against Eli Lilly for indirect promotion of obesity treatments, alongside expansions of compassionate access frameworks covering gene therapies (LUMEVOQ) and immuno-oncology combinations (Agenus botensilimab/balstilimab), and the launch of a fast-track clinical trial authorization pathway with potential 14-day approval for select mono-national trials.

Name

ANSM

Legal name

Agence nationale de sécurité du médicament et des produits de santé

Website

https://ansm.sante.fr

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

501–1,000 employees

Short description

ANSM is France's national regulatory agency overseeing the safety, efficacy, and quality of medicines, vaccines, biological products, medical devices, and cosmetics. It operates vigilance networks and manages market authorization, post-market surveillance, and compassionate access programs throughout France.

Ownership category

akta.pro rank

Product category

Pharmaceutical and Health Product Regulation

NAICS

Justice, Public Order, and Safety Activities (922)

akta.pro primary industry

Biologics & Vaccine Regulators (HLAJADAB)

akta.pro secondary industries

Drug Regulators (Human Pharmaceuticals) (HLAJADAA), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ)

Keywords

• Medicines regulation
• Health product safety
• Pharmacovigilance oversight
• Medical device regulation
• Drug safety authority

Headquarters

HQ city

Saint-denis

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure

Revenue model

1. Government Funding: ANSM is a French government agency funded by the state budget. The agency does not generate commercial revenue but is sustained through public funding allocated by the French government for regulatory and safety oversight functions.

Distribution channels4 records

Marketing channels7 records

Core offering

ANSM is France's national regulatory agency that authorizes, monitors, and enforces the safety of medicines, vaccines, biological products, medical devices, in vitro diagnostics, and cosmetics throughout their lifecycle. The agency conducts market authorization reviews, manufacturing facility inspections, post-market pharmacovigilance and mat\u00e9riovigilance surveillance, and publishes official safety information. It also manages compassionate and early access programs enabling patient access to investigational therapies.

Product overview

ANSM (Agence nationale de sécurité du médicament et des produits de santé) is France's national regulatory agency for health product safety, not a commercial software product company. Its digital offerings consist of regulatory information systems and public-facing web applications rather than a unified commercial product. The agency operates several web-based platforms including the Vigimater application for materiovigilance incident tracking, a Data ANSM public data portal, the Public Drug Database, the ReCann medical cannabis patient registry, and the Signalement portal for adverse event reporting. These systems serve the agency's public health mandate of facilitating access to health products while ensuring their safety throughout their lifecycle.

Differentiator

Problem solved

Functional benefit

Products and services

• Vigimater Web-based application allowing mat\u00e9riovigilance declarants to track the progress of medical device incident reports; contains incidents recorded since January 1, 2019 and is updated periodically.
• Data ANSM Public data portal providing access to aggregated and anonymized health product safety data managed by ANSM.
• Public Drug Database (Base de donn\u00e9es publique des m\u00e9dicaments) Public database of medications accessible to citizens, providing information on authorized pharmaceutical products available in France.
• ReCann (Registre \u00e9lectronique national du cannabis m\u00e9dical) Electronic national registry for tracking patients in the medical cannabis experimentation program, managed by prescribing physicians and pharmacists.
• Signalement Portal Government portal for reporting adverse drug reactions, medical device incidents, and other health product safety events by patients, healthcare professionals, and manufacturers.

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Seven partnerships are on record, tiered core.

• Regional pharmacovigilance centers (CRPV)coreOthersANSM works in coordination with 31 regional pharmacovigilance centers that evaluate adverse drug reaction reports at the local level before escalation to national oversight. These centers form the frontline of France's drug safety surveillance network.
• Regional matériovigilance and réactovigilance coordinators (CRMRV)coreOthersANSM coordinates with regional matériovigilance coordinators for medical device incident surveillance and réactovigilance coordinators for in vitro diagnostic device monitoring throughout France.
• Addictovigilance centers (CEIP-A)coreOthersCenters for evaluation and information on pharmacodependence-addictovigilance work with ANSM to monitor addiction-related risks associated with medications and substances.
• Regional hemovigilance coordinators (CRH-ST)coreOthersANSM partners with regional hemovigilance and transfusion safety coordinators to oversee blood product safety across France's healthcare facilities.
• European Medicines Agency (EMA)coreOthersANSM participates in EMA scientific committees including PRAC, CHMP, CMDh, COMP, PDCO, and HMPC, contributing to European medicines regulation while maintaining national oversight responsibilities.
• European Directorate for the Quality of Medicines (EDQM)coreOthersANSM collaborates with the EDQM on pharmacopoeia standards and quality assurance for medicines across Europe.
• Health insurance (Assurance Maladie)coreStrategic or Co-development PartnerANSM partners with the French national health insurance system on studies such as Perimed investigating unused medicines, and joint campaigns on medication safety and good usage practices.

Scale indicators1 record

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• European Medicines Agency (EMA): EU-level medicines regulator that ANSM directly contributes to via PRAC, CHMP, CMDh, COMP, PDCO, and HMPC. EMA operates centralized authorization procedures across all member states, overlapping with and partially superseding ANSM's national authority.
• U.S. Food and Drug Administration (FDA): The largest national medicines and health products regulator globally, with parallel mandates covering drug authorization, biologics, medical devices, and post-market surveillance — a direct functional analogue to ANSM at a different jurisdictional scale.

Direct peers

• Therapeutic Goods Administration (TGA Australia): Australia's national regulator for therapeutic goods, including medicines, biologicals, and medical devices. TGA shares ANSM's single-jurisdiction structure with comparable pre-market assessment and adverse event reporting systems.
• AIFA (Italian Medicines Agency): Italy's national medicines authority responsible for regulatory authorization, pharmacovigilance, and pricing/reimbursement of pharmaceuticals. A direct EU peer with similar statutory structure and oversight responsibilities as ANSM.
• Medicines and Healthcare products Regulatory Agency (MHRA): UK national regulator for medicines, medical devices, and blood products post-Brexit. MHRA operates an analogous end-to-end mandate covering pharmacovigilance, clinical trial authorization, and market access — directly comparable to ANSM's scope.
• BfArM (Federal Institute for Drugs and Medical Devices, Germany): Germany's federal regulator for human pharmaceuticals and medical devices, with parallel clinical trial authorization, pharmacovigilance, and market authorization functions to ANSM. A peer EU member-state regulator of comparable scale and remit.
• Health Canada: Canada's federal health product regulator responsible for medicines, biologics, medical devices, and cosmetics safety. Operates a comparable federal mandate to ANSM with similar pre-market authorization and post-market surveillance functions.
• AEMPS (Spanish Agency for Medicines and Health Products): Spain's national medicines and health products regulator covering authorization, pharmacovigilance, and inspection. Operates an equivalent single-country mandate to ANSM with shared EU regulatory cooperation framework.

Regional players

• Swissmedic: Swiss national regulator for therapeutic products covering medicines, medical devices, and veterinary medicines. Operates analogous pre-market authorization and pharmacovigilance functions outside the EU but with a comparable single-country regulatory mandate to ANSM.

Others

• European Directorate for the Quality of Medicines (EDQM): Council of Europe body responsible for pharmacopoeia standards and medicines quality, with which ANSM maintains an explicit collaboration. Functions as a complementary European regulatory infrastructure rather than a direct competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/ansm
• YouTubeyoutube.com/channel/UCLwzdfn_TDPGx7pv7nbDryQ
• LinkedInfr.linkedin.com/company/ansm

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about ANSM