France

France's primary regulatory authority for health products is the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), established under the Public Health Code (Code de la Santé Publique). ANSM oversees the authorization, surveillance, and control of medicines, medical devices, diagnostics, and digital health solutions marketed in France. For pharmaceuticals, market authorization may be obtained via centralized European Medicines Agency (EMA) procedures, mutual recognition or decentralized procedures, or a national procedure handled directly by ANSM. Medical devices and in vitro diagnostics are regulated under EU MDR (2017/745) and EU IVDR (2017/746), requiring CE marking through a Notified Body before market access. Digital health solutions classified as Software as a Medical Device (SaMD) follow the same MDR/IVDR framework, with additional national pathways such as the early access and reimbursement framework for digital health tools (Article 53 of the Social Security Financing Law).

Submission dossiers for pharmaceuticals must conform to the Common Technical Document (CTD) format as required under European regulatory standards. A local Responsible Person or EU-qualified legal representative is mandatory for non-EU manufacturers. France has implemented several notable reforms in recent years, including the early access authorization (Autorisation d'Accès Précoce, AAP) system introduced by the Health Innovation Law (Loi de Financement de la Sécurité Sociale 2021), which replaced the former Temporary Authorization for Use (ATU) scheme. This allows promising medicines to reach patients before formal marketing authorization under specific conditions. Additionally, the Espace Numérique en Santé (ENS) framework governs digital health interoperability, and ANSM has introduced expedited review tracks for products addressing unmet medical needs or public health emergencies.

Public procurement of health products in France is managed through a centralized and semi-centralized structure overseen by the Ministry of Health and Prevention (Ministère de la Santé et de la Prévention), in coordination with the Caisse Nationale d'Assurance Maladie (CNAM), which administers the national health insurance system. Reimbursement decisions for pharmaceuticals are informed by the Haute Autorité de Santé (HAS), which evaluates clinical benefit (Service Médical Rendu, SMR) and added therapeutic benefit (Amélioration du Service Médical Rendu, ASMR), and by the Economic Committee for Health Products (Comité Economique des Produits de Santé, CEPS), which negotiates pricing with manufacturers. Hospitals procure health products through national and regional grouping bodies, most notably UniHA (Uni-HA) and Resah, which aggregate purchasing power across public hospitals and negotiate framework contracts. The Agence Générale des Equipements et Produits de Santé (AGEPS), affiliated with the Paris Public Hospital Network (AP-HP), also plays a significant role in centralized hospital procurement.

The private sector in France represents a substantial channel, including private hospitals, outpatient pharmacies, and independent diagnostic laboratories, all operating within the reimbursement framework set by CNAM. France is a high-income country and does not typically rely on donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, USAID, or Gavi for domestic health product supply. However, French manufacturers and institutions participate in international humanitarian and development procurement through these channels for exports. France does not impose formal local manufacturing preference requirements for domestic procurement, though national resilience and sovereignty in health supply chains have become policy priorities following the COVID-19 pandemic, reflected in initiatives such as the France Relance plan and investments in domestic production capacity for critical medicines and medical countermeasures.