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 Law of 29 December 2011 (Loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé). ANSM operates under the supervision of the Ministry of Health and is responsible for the authorization, surveillance, and control of pharmaceuticals, medical devices, diagnostics, and digital health solutions. Pharmaceutical products may obtain market authorization either through the centralized European Medicines Agency (EMA) procedure, the decentralized procedure, the mutual recognition procedure, or a national procedure administered directly by ANSM. Medical devices are governed by EU Regulations MDR 2017/745 and IVDR 2017/746, with conformity assessment conducted by designated Notified Bodies and market surveillance overseen by ANSM. Digital health solutions (logiciels de dispositifs medicaux) are assessed under the same MDR/IVDR framework when they qualify as medical devices, while a national certification framework, Mon Espace Sante, supports broader digital health ecosystem integration.

For pharmaceutical submissions, France accepts dossiers in Common Technical Document (CTD) format, aligned with ICH guidelines and European regulatory standards. A local authorized representative or marketing authorization holder established within the European Economic Area is mandatory for all market authorization applications. Medical device manufacturers outside the EU must appoint an EU-authorized representative. ANSM has undertaken significant reform efforts in recent years, including the implementation of an early access authorization scheme (Autorisation d'Acces Precoce, AAP) introduced by the Health System Organization Law of 2021 (Loi de financement de la securite sociale), replacing the former Autorisation Temporaire d'Utilisation (ATU) system. This reform accelerated patient access to innovative therapies prior to full marketing authorization and introduced a revised reimbursement negotiation pathway through the Haute Autorite de Sante (HAS) and the Economic Committee for Health Products (CEPS).

Public procurement of health products in France is centrally coordinated through the Ministry of Health and Prevention (Ministere de la Sante et de la Prevention), with reimbursement and pricing decisions governed by the Haute Autorite de Sante (HAS) and negotiated pricing agreements managed by the Comite Economique des Produits de Sante (CEPS). Pharmaceuticals seeking reimbursement under the national health insurance system (Assurance Maladie) must undergo a two-stage assessment: a clinical benefit evaluation (Service Medical Rendu, SMR) and an assessment of added therapeutic benefit (Amelioration du Service Medical Rendu, ASMR) conducted by HAS. Medical devices seeking reimbursement must be listed on the Liste des Produits et Prestations Remboursables (LPPR), following a similar HAS evaluation process. Hospital procurement is conducted through regional grouping mechanisms and national frameworks managed by the Union des Groupements d'Achats Publics (UGAP) and hospital purchasing consortia such as UniHA and Resah, which aggregate demand across public hospitals and healthcare institutions to negotiate volume-based pricing and supply agreements.

The private healthcare sector in France is substantial, encompassing private clinics, specialist outpatient facilities, and pharmacy retail networks, all operating within the broader social health insurance reimbursement framework. Private procurement follows national reimbursement list prices but may involve direct negotiation for non-reimbursed products. France is a high-income country and is not a primary recipient of donor-funded procurement programs such as those managed by UNICEF Supply Division, the Global Fund, USAID, or Gavi; however, French manufacturers and distributors are active suppliers within these international procurement channels for global health markets. France maintains a strong strategic interest in domestic and European manufacturing resilience, reinforced by the European Health Union agenda and national initiatives such as the France Relance plan, which supports reindustrialization of pharmaceutical and medical device production on French territory. Local manufacturing preference is not a formal legal requirement for public procurement but is increasingly factored into strategic sourcing decisions and government-supported investment incentives.