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 Ministry of Health and Prevention (Ministère de la Santé et de la Prévention). The legal framework is anchored in the Code de la Santé Publique, which governs the authorisation, surveillance, and post-market oversight of pharmaceuticals, medical devices, in vitro diagnostics, and digital health solutions. Pharmaceuticals may obtain market authorisation via the centralised European Medicines Agency (EMA) procedure, the decentralised procedure, the mutual recognition procedure, or a purely national procedure administered by ANSM. Medical devices and diagnostics are regulated under EU Regulations MDR 2017/745 and IVDR 2017/746 respectively, with CE marking serving as the primary market-entry mechanism, supported by ANSM's vigilance and post-market surveillance mandate. Digital health solutions (logiciels de dispositifs médicaux) follow the same MDR/IVDR classification pathways where applicable, with additional oversight from the Haute Autorité de Santé (HAS) for reimbursement eligibility assessments.

Submission dossiers for pharmaceutical products must comply with the Common Technical Document (CTD) format as adopted by the International Council for Harmonisation (ICH), and foreign applicants are required to designate an EU-based Marketing Authorisation Holder or local legal representative. For medical devices, technical documentation must align with Annex II and III requirements of MDR/IVDR, and manufacturers outside the EU must appoint an EU Authorised Representative. France has implemented notable reforms in recent years, including the early access authorisation (autorisation d'accès précoce, AAP) mechanism introduced by the Loi de financement de la Sécurité sociale (LFSS) 2021, replacing the former Autorisation Temporaire d'Utilisation (ATU) framework. This reform accelerated patient access to innovative therapies prior to full marketing authorisation. Additionally, HAS continuously updates its methodological guidance for the assessment of medical devices and digital health tools, including the PECAN (Parcours d'Evaluation pour la Certification et l'Accès Numérique) pathway for digital health products, reflecting France's commitment to structured horizon-scanning and value-based evaluation.

Public procurement of health products in France is primarily coordinated through the Ministry of Health and Prevention and the national health insurance system, the Assurance Maladie, administered by the Caisse Nationale de l'Assurance Maladie (CNAM). Reimbursement and pricing decisions for pharmaceuticals are negotiated between the Comité Economique des Produits de Santé (CEPS) and manufacturers, following a clinical and economic assessment by the Haute Autorité de Santé (HAS), specifically through its Transparency Commission (CT) for medicines and its National Commission for Medical Devices and Health Technologies (CNEDiMTS) for devices. Products are listed on the Liste des Produits et Prestations Remboursables (LPPR) for devices or on the Remboursement list for pharmaceuticals, with reimbursement rates set in relation to the product's assessed clinical benefit (Service Médical Rendu, SMR) and added clinical value (Amélioration du Service Médical Rendu, ASMR). Hospital procurement is conducted at the institutional and regional level, with university hospital consortia (groupements hospitaliers de territoire, GHT) playing an increasing role in aggregating purchasing power and conducting joint tenders under the Public Procurement Code (Code de la Commande Publique). National and regional purchasing groups, such as UniHA and the CAHPP, further centralise hospital procurement and negotiate framework agreements that individual institutions may draw upon, promoting cost efficiency and standardisation across the public hospital sector.

The private healthcare sector in France is substantial, encompassing private clinics, ambulatory care networks, and retail pharmacy chains, which procure health products through wholesale distributors and direct manufacturer agreements, operating within pricing and margin frameworks established by regulatory authorities. France is a high-income country and does not typically rely on donor-funded procurement mechanisms such as those administered by UNICEF Supply Division, the Global Fund, USAID, or Gavi; access to these channels is not a standard route to the French market. However, French public institutions and manufacturers are active participants in European joint procurement mechanisms, including those coordinated by the European Commission for pandemic-related countermeasures and strategic health reserves. France has articulated a strong policy preference for reinforcing European health sovereignty and local manufacturing capacity, as reflected in the France Relance and France 2030 investment plans, which include dedicated funding to support domestic production of active pharmaceutical ingredients (APIs), vaccines, and medical technologies. This industrial strategy creates opportunities and expectations for manufacturers to demonstrate local production or supply chain resilience commitments when engaging with public procurement authorities.