France

France's primary regulatory authority for health products is the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), operating under the oversight of the Ministère de la Santé et de la Prévention. The legal framework is anchored in the Code de la Santé Publique, supplemented by European Union regulations and directives including Regulation (EU) 2017/745 for medical devices, Regulation (EU) 2017/746 for in vitro diagnostics, Directive 2001/83/EC for medicinal products, and the EU MDR/IVDR transition frameworks. Pharmaceuticals may obtain market authorization through the centralized European Medicines Agency (EMA) procedure, the mutual recognition procedure, the decentralized procedure, or a national procedure managed directly by ANSM. Medical devices and diagnostics must bear CE marking under the relevant EU regulations, with Notified Bodies playing a central conformity assessment role. Digital health products are additionally subject to the national certification framework for digital health tools (the Espace Numérique de Santé ecosystem), overseen by the Agence du Numérique en Santé (ANS).

Applicants seeking market access in France must submit dossiers aligned with the Common Technical Document (CTD) format for pharmaceuticals, or the relevant EU technical documentation requirements for devices and diagnostics. A locally registered legal representative within the European Economic Area is mandatory for non-EU manufacturers. France has been at the forefront of implementing the EU MDR and IVDR transition timelines and has adopted stricter post-market surveillance and clinical evidence requirements accordingly. Notable recent reforms include the acceleration of early access authorization (Autorisation d'Accès Précoce, AAP) pathways for innovative medicines and devices addressing unmet medical needs, replacing the former Autorisation Temporaire d'Utilisation (ATU) framework. The Haute Autorité de Santé (HAS) conducts subsequent health technology assessment (HTA), including the Service Médical Rendu (SMR) and Amélioration du Service Médical Rendu (ASMR) evaluations, which directly influence reimbursement eligibility and pricing negotiations with the Comité Economique des Produits de Santé (CEPS).

Public procurement of health products in France operates within a centralized national framework governed by the Ministère de la Santé et de la Prévention and the Ministère de l'Économie et des Finances, with procurement rules defined by the Code de la Commande Publique. The primary public payer and reimbursement authority is the Assurance Maladie (national health insurance system), administered through the Caisse Nationale de l'Assurance Maladie (CNAM). Hospital procurement is conducted at the institutional and grouping level, with university hospitals (CHUs) and hospital groups often pooling purchasing power through regional or national groupements d'achat (purchasing consortia) such as UniHA and the UGAP. Pricing for reimbursed pharmaceuticals is negotiated between manufacturers and the CEPS following a positive HAS opinion, while medical device reimbursement is governed by the Liste des Produits et Prestations Remboursables (LPPR). National health strategies, including the Ma Santé 2022 and Ségur de la Santé reform programs, have further shaped procurement priorities around digital health infrastructure, hospital modernization, and pandemic preparedness stockpiling coordinated by Santé Publique France.

The private healthcare sector in France is substantial, encompassing private clinics (cliniques privées), independent practitioners, and retail pharmacy networks, all of which procure health products through wholesaler-distributors and direct manufacturer agreements operating alongside the public reimbursement framework. France does not rely significantly on multilateral donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, USAID, or Gavi for its domestic health market, as it is a high-income country and a donor nation itself. However, French manufacturers and institutions engage actively with these channels for export and global health initiatives. France maintains a strategic interest in European supply chain resilience and has introduced policies incentivizing the relocation of pharmaceutical and medical product manufacturing to France and the EU, including tax incentives and public investment through the France Relance and France 2030 industrial strategies. Preference for locally or EU-manufactured products is increasingly embedded in public tender criteria, particularly for critical medicines and strategic health commodities identified following COVID-19 supply disruptions.